Prostate Cancer

Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT06074510

Sponsor: Lantheus Medical Imaging

Phase: Phase 4

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• 1. Patients must have the ability to understand and sign an approved informed consent form (ICF) 2. Patients must have the ability to understand and comply with all protocol requirements 3. Patients must be ≥ 18 years of age 4. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 5. Patients with life expectancy of at least 13 months as determined by the investigator 6. Patients must have confirmed favorable intermediate risk (FIR) adenocarcinoma of the prostate per 2023 NCCN guidelines. FIR risk group confirmation includes all the following:
• 1 intermediate risk factor (cT2b-cT2c or ISUP Grade Group 2 or PSA 10-20 ng/mL)
• ISUP Grade Group 1 or 2
• <50% biopsy cores positive (e.g., <6 of 12 cores) Note: Date of the prostate biopsy should be no sooner that 2 weeks and no later than 3 months prior to PYLARIFY PET imaging

Exclusion Criteria:

1. Patients administered any high energy (>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to Day 1 (PYLARIFY imaging)
2. Previous Prostate cancer treatment including radiation, androgen deprivation therapy, brachytherapy, surgery, prostate ablation, hormonal therapies or investigational therapy
3. Known hypersensitivity to the components of PYLARIFY or its analogs
4. Patients with any medical condition or other circumstances that, in the opinion of the investigator, compromise the safety or compliance of the subject to produce reliable data or complete the study
5. Patients who have any radiographic evidence of T3, N1 or M1 disease on SOC imaging (if performed)

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Condition: Bladder Cancer, Breast Cancer, Colon Cancer, Endometrial Cancer, Ovarian Cancer, Rectal Cancer, Prostate Cancer, Renal Cell Carcinoma, Kidney Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05056077

Sponsor: University of California, San Francisco

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

Inclusion Criteria:

1. INCLUSION CRITERIA FOR CANCER SURVIVORS:
2. >= 18 years of age.
3. Diagnosis of bladder, breast, colon, endometrial, kidney (renal cell carcinoma), ovarian, prostate, or rectal cancer.
4. Completed all cytotoxic chemotherapy, immunotherapy, targeted therapies, or radiation (if indicated) prior to enrollment. Hormonal treatments for breast and prostate cancer are allowed.
5. Owns a smart phone that has access to the Internet and can receive daily text messages.
6. Able to speak and read English or Spanish
7. Have a support person >= 18 years of age who speaks English or Spanish and is willing to provide informed consent and support the participant throughout the study.
8. >= 4 weeks since a major surgery to start of intervention (removal of port or catheter (cath) is not major surgery; reversal of ostomy is major surgery and will require at least 4 weeks prior to enrollment).
9. Readiness, as determined by the Physical Activity Readiness Questionnaire (PAR-Q). If there are any indications that home-based exercise might be unsafe based on PAR-Q, the patient will not be enrolled until confirmation from the patient's provider is received via email and/or phone that they are safe to exercise. Providers do not need to be contacted if patients answer 'yes' to 'Is your doctor currently prescribing any medication for your blood pressure or for a heart condition? INCLUSION CRITERIA FOR SUPPORT PERSONS:
10. Identified by a cancer survivor participant who has consented to participate in Tools To Be Fit as their support person.
11. 18 years of age or older.
12. Speaks and reads English or Spanish.
13. Consents to complete two online surveys and four 1-on-1 health coaching calls during the 48 week study. Exclusion Criteria: EXCLUSION CRITERIA FOR CANCER SURVIVORS:
14. People with potential contraindications to home-based exercise based on the PAR-Q for whom the investigator is unable to obtain physician clearance.
15. ACS guideline score of > 4 out of 6 at enrollment based on self-reported diet, BMI, and physical activity. Our screening survey will ask participants to report their height and weight; usual intake of foods in the ACS guidelines (e.g., red and processed meat, fruits, vegetables, grains); and the Godin Leisure Time Exercise Survey.
16. Used a physical activity tracker and a diet tracking app for >= 1 week in the past 3 months; these are components of our digital health tool kit.
17. Planned major surgery during the study period (removal of port or cath or dermatological procedures excluded)
18. Scheduled to receive any form of cancer therapy during the study period with the exception of hormonal treatments for breast and prostate cancer, which are allowed.
19. History of severe cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. Examples include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility.
20. History of psychiatric disorders that would preclude participation in the study intervention (e.g., untreated major depression or psychosis, substance abuse, severe personality disorder) or prevent the patient from giving informed consent.
21. Participating in another weight loss, physical activity or dietary intervention clinical trial. Co-enrollment in some trials involving pharmacologic therapy is allowed. Participants are also allowed to pursue weight loss and physical activity programs on their own, as long as these programs are not provided as part of a clinical trial.
22. Currently pregnant or trying to become pregnant during the study period.
23. Living outside the United States during screening and/or the 48-week study period.

Exclusion Criteria:

1. EXCLUSION CRITERIA FOR CANCER SURVIVORS:
2. People with potential contraindications to home-based exercise based on the PAR-Q for whom the investigator is unable to obtain physician clearance.
3. ACS guideline score of > 4 out of 6 at enrollment based on self-reported diet, BMI, and physical activity. Our screening survey will ask participants to report their height and weight; usual intake of foods in the ACS guidelines (e.g., red and processed meat, fruits, vegetables, grains); and the Godin Leisure Time Exercise Survey.
4. Used a physical activity tracker and a diet tracking app for >= 1 week in the past 3 months; these are components of our digital health tool kit.
5. Planned major surgery during the study period (removal of port or cath or dermatological procedures excluded)
6. Scheduled to receive any form of cancer therapy during the study period with the exception of hormonal treatments for breast and prostate cancer, which are allowed.
7. History of severe cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. Examples include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility.
8. History of psychiatric disorders that would preclude participation in the study intervention (e.g., untreated major depression or psychosis, substance abuse, severe personality disorder) or prevent the patient from giving informed consent.
9. Participating in another weight loss, physical activity or dietary intervention clinical trial. Co-enrollment in some trials involving pharmacologic therapy is allowed. Participants are also allowed to pursue weight loss and physical activity programs on their own, as long as these programs are not provided as part of a clinical trial.
10. Currently pregnant or trying to become pregnant during the study period.
11. Living outside the United States during screening and/or the 48-week study period. EXCLUSION CRITERIA FOR SUPPORT PERSONS:
12. None.

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Condition: Metastatic Castration-resistant Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT06228053

Sponsor: Syntrix Biosystems, Inc.

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• 1. Signed and dated Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent form prior to beginning study and undergoing procedures. 2. Diagnosis of mCRPC with (a) any histology, (b) measurable disease at enrollment, and (c) currently on or previously on abiraterone with prednisone in either the mCRPC or mHSPC settings, and with:
• rising PSA (a rising PSA requires at least 3 measurements obtained at least 1 week apart showing increase from nadir with the last level above 2 ng/mL by local testing); or
• progression of new or existing bone or soft tissue metastatic lesions by CT, MRI or bone scan;
• no abiraterone washout necessary. 3. Availability of archival tumor tissue for pathologic review and correlative studies. Tumor tissue (localized or metastatic) does not need to be received but rather identified and available (slides and blocks) upon later request for future pathologic review and possible correlative studies. 4. Castrate levels of serum total testosterone (<50 ng/dl) OR ongoing documented ADT. 5. Karnofsky performance status of 70 or higher. 6. ≥ 18 years of age 7. Life expectancy of ≥ 6 months 8. Recovered to ≤ Grade 2 toxicity from prior therapy (per CTCAE Version 5.0) 9. Adequate bone marrow function:
• Absolute neutrophil count (ANC) ≥ 1.2 × 109/L without any growth factors in prior 7 days
• Hemoglobin ≥ 9.0 g/dL with no blood transfusion in the prior 14 days
• Platelet count ≥ 75 × 109/L with no platelet transfusion in the prior 7 days Adequate hepatic function:
• Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for Gilbert's syndrome)
• AST (serum glutamic oxaloacetic transaminase [SGOT]) / ALT (serum glutamic pyruvate transaminase [SGPT]) ≤ 3 × institutional ULN Adequate renal function:
• Creatinine clearance per Cockcroft-Gault equation (or institutional equivalent) of ≥ 50 mL/min 10. Willingness of patients who are not surgically sterile or with partners who are not postmenopausal to use medically acceptable methods of birth control for the duration of the study treatment, including 90 days after the last dose of study drug. 11. Willing and able to provide written informed consent and HIPAA authorization for the release of personal health information.

Exclusion Criteria:

• 1. Prior systemic anticancer treatment:
• Prior treatment with docetaxel or marketed antibody within 4 weeks of first dose of study treatment
• Prior radium-223 therapy within 6 weeks
• Prior PSMA-Lu177-617 therapy within 4 weeks 2. Prior receipt of (a) ketoconazole or any second-generation AR antagonist (e.g., enzalutamide, apalutamide, darolutamide), (b) 2 or more chemotherapy regimens with docetaxel or (c) any chemotherapy other than docetaxel. 3. Current presence of liver metastases on imaging. 4. Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease. 5. Major surgery requiring general anesthesia within 3 weeks of starting study treatment (limited biopsy or line placement is acceptable) 6. Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. 7. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention. 8. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. 9. Congestive heart failure (New York Heart Association Class III or IV) or unstable angina pectoris; previous history of myocardial infarction within one year prior to study entry, uncontrolled hypertension, or uncontrolled arrhythmias. 10. Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. 11. Has known active untreated CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment greater than prednisone 10 mg daily (or equivalent) for at least 14 days prior to first dose of study intervention. 12. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed. 13. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. 14. Has an active infection requiring systemic therapy. 15. Has a known uncontrolled Human Immunodeficiency Virus (HIV) infection based on detectable HIV viral load and abnormal CD4 count of <350/mm3. 16. Has a known active Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. 17. Has a known active TB (Bacillus Tuberculosis) infection. 18. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. 19. Has known current psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 20. Has had an allogenic tissue/solid organ transplant. 21. Concomitant medication(s) known to be (a) a strong inhibitor or inducer of CYP3A4, or (b) QT prolonging as defined in the drug's approved label, with the exception of drugs that are considered absolutely essential for the care of the subject or if the Investigator believes that beginning therapy with such medication is vital to an individual subject's care while on study, and in either case, there is no alternative drug (if exceptions apply contact Syntrix medical monitor prior to enrollment). 22. ECG demonstrating a QTc interval > 470 msec or patients with congenital long QT syndrome. 23. Coronary artery bypass, angioplasty, vascular stent, myocardial infarction, angina or congestive heart failure in the last 6 months.

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Condition: Prostate Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04597359

Sponsor: ECOG-ACRIN Cancer Research Group

Phase: Phase 2

Eligibility:

• Age: minimum 21 Years maximum N/A
• Gender: All

Inclusion Criteria:

• INCLUSION CRITERIA FOR PREREGISTRATION (STEP 0: SCREENING)
• Patient must have biopsy-proven (consisting of >= 12 tissue cores) adenocarcinoma of the prostate with cancer present in at least one biopsy core in the most recent biopsy using initial transrectal ultrasound (TRUS) biopsy or TRUS biopsy followed by multiparametric magnetic resonance imaging (mpMRI) of the prostate and a confirmatory targeted biopsy
• Patient must be on active surveillance (very low, low and favorable intermediate risk as defined by the National Comprehensive Cancer Network [NCCN])
• Patient must be scheduled for a follow up prostate biopsy 6 months after the initiation of treatment on this study
• Patient must have a serum PSA < 10 ng/mL or prostate specific antigen density (PSAD) < 0.15 ng/mL/ g obtained within 30 days of registration
• Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Patient must be willing to abstain from consumption of any supplements containing green tea catechins
• Patient must be willing to restrict tea consumption to less than three (3) servings of hot tea or three (3) servings of iced tea per week (serving size of 8 oz)
• Patient must be willing to discontinue current vitamin/mineral supplement use and use one provided by study
• Patient must be willing to take study agent or placebo at the dose specified with meals
• Patient must have the ability to understand and the willingness to sign a written informed consent document
• Absolute neutrophil count >= 1,200/mm^3 (>= 1.2 k/uL) (obtained within 30 days prior to registration)
• Platelets >= 75,000/mm^3 (>= 75 k/uL) (obtained within 30 days prior to registration)
• Total bilirubin =< 1.2 mg/dL (or =< 3.0 mg/dL for patients with Gilbert's syndrome) (obtained within 30 days prior to registration)
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 1.5 x upper limit of normal (ULN) (obtained within 30 days prior to registration)
• Serum creatinine =< 1.5 x ULN (obtained within 30 days prior to registration)
• Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
• Sexually active males must use an accepted and effective method of double barrier contraception (vasectomy must be combined with a physical barrier method) or abstain from sexual intercourse for the duration of their participation in the study
• Patients must have archived formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen available for Gleason score confirmation and % Ki-67 expression (5% or more) in tumor tissue for eligibility and stratification. Tumor tissue can be submitted any time during screening
• Tumor tissue specimen has been collected and is ready to ship to H. Lee Moffitt Cancer Center & Research Institute
• H. Lee Moffitt Cancer Center & Research Institute will perform Gleason score confirmation and % Ki-67 expression (5% or more) in tumor tissue and notify the Eastern Cooperative Oncology Group-American College of Radiology Imaging Network (ECOG-ACRIN) Operations Office and submitting institution within 3-4 business days of receipt of the tumor tissue specimen
• INCLUSION CRITERIA FOR RANDOMIZATION (STEP 1)
• Patient must meet all Step 0

Eligibility Criteria:

• at the time of their registration to Step 1
• Patient must have Gleason score (3+3) or predominant Gleason pattern 3 (3+4), =< 33% of biopsy cores, and =< 50% involvement of any biopsy core
• Patient must have % Ki-67 expression of 5% or more in tumor tissue Exclusion Criteria:

Exclusion Criteria:

• EXCLUSION CRITERIA FOR PREREGISTRATION (STEP 0: SCREENING)
• Patient must not have had prior treatment for prostate cancer, including focal therapy, with surgery, irradiation, local ablative (i.e., cryosurgery or high-intensity focused ultrasound), or androgen deprivation therapy
• Patient must not have a history of renal or hepatic disease, including history of hepatitis B and C
• Patient must not have prostate cancer with distant metastases
• Patient must not have undergone treatment of hormone therapy, immunotherapy, chemotherapy and/or radiation for any malignancies within the past 2 years. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
• Patient must not receive any other investigational agents while on this study
• Patient must not have a history of allergic reactions attributed to tea or other compounds of similar chemical or biologic composition to green tea extracts

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Condition: Prostate Cancer, Prostate Cancer Metastatic

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT06171139

Sponsor: University of California, San Francisco

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

1. Stage 1:
2. Age 18-years-old or older
3. Identifies as Black or African American, by either chart documentation or participant self-report. Mixed-race including Black or African American is included.
4. Metastatic prostate cancer, by either chart documentation or participant self-report. Pathology report not needed.
5. Able to understand study procedures and to comply with them for the entire length of the study.
6. Able to understand a written information sheet and willing to verbally consent.
7. Fluent in English (reading, writing, and speaking) Stage 2:
8. Age 18-years-old or older
9. Identifies as Black or African-American, by either chart documentation or participant self-report. Mixed-race including Black or African-American is included.
10. Metastatic prostate cancer, by either chart documentation or participant self-report. Pathology report not needed.
11. Able to understand study procedures and to comply with them for the entire length of the study.
12. Fluent in English (reading, writing, and speaking).
13. Anticipated discussion of TGT within 0-90 days of enrollment, per treating oncology provider's discretion. TGT involves use of any cancer genetic sequencing (whether standard-of-care or part of a research protocol) via any one of the following:
14. Somatic DNA testing of already-collected tissue.
15. Somatic DNA testing of tissue to be collected in the future via biopsy, surgery, or other procedure.
16. Blood-based DNA testing to evaluate for circulating tumor DNA.
17. Able to understand a written informed consent document and willing to sign it.

Exclusion Criteria:

1. Contraindication to any study-related procedure or assessment in either stage.

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Condition: Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8, Solid Tumor, Adult, Solid Tumor, Metastatic Castration-resistant Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04927663

Sponsor: Rahul Aggarwal

Phase: Phase 1

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

1. 1.

Disease Characteristics:

• by cohort, as defined by:
• COHORT A: Histologically confirmed metastatic solid tumor malignancy.
• COHORT B: Metastatic castration-resistant prostate cancer with progression on systemic therapies by PCWG3.
• COHORT C: Metastatic advanced solid tumor malignancy other than prostate adenocarcinoma with at least one metastasis on conventional imaging. 2. The subject is able and willing to comply with study procedures and provide signed and dated informed consent. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Age 18 years or older at the time of study entry. 5. Adequate organ function, as defined by: 1. Serum creatinine =< 1.5 x upper limit of normal (ULN) OR estimated creatinine clearance > 50 ml/min 2. Total bilirubin =< 1.5 x ULN 3. Hemoglobin >= 8.0 g/dL 4. Platelet count >= 50,000/microliter 5. Absolute neutrophil count >= 1000/microliter

Exclusion Criteria:

1. Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
2. Concurrent treatment with any dose of systemic glucocorticoids within 7 days prior to cycle 1 day 1 (C1D1).
3. History of adrenal insufficiency requiring use of systemic glucocorticoid replacement.
4. History of Cushing's disease or Cushing's syndrome.
5. Any condition that, in the opinion of the principal investigator, would impair the patient's ability to comply with study procedures.
6. Contra-indication to MRI (e.g. pacemaker placement, severe claustrophobia) (applicable only for patients scheduled for PET/MRI).

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Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05617040

Sponsor: Barinthus Biotherapeutics

Phase: Phase 1/Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• 1. Males aged 18 years and above at the time of signing the informed consent. 2. Histologically or cytologically confirmed adenocarcinoma of the prostate. 3. Has undergone primary therapy for prostate cancer (radical prostatectomy and/or definitive external beam radiation and/or brachytherapy). Salvage external radiation therapy (XRT) following radical prostatectomy >6 months prior to Day 1 is allowed. 4. No further local therapy to prostate or systemic therapy for prostate cancer and no metastasis-directed therapy for PSA positron emission tomography (PET) positive lesions planned within 4 months after the first dose of VTP-850. 5. Serum testosterone >175 ng/dL. 6. Nonmetastatic (M0) disease and no evidence of prostatic bed recurrence verified by whole body bone scintigraphy and either CT or MRI. Note that a positive PSMA PET does not exclude the participant if the conventional scans are negative. 7. Serum PSA of >0.3 ng/mL for participants with prior radical prostatectomy (with or without salvage radiotherapy), or serum PSA of 2 ng/mL above nadir for participants with prior external beam radiation or brachytherapy. 8. PSA doubling time ≤12 months. 9. Not planning to start ADT for at least 4 months after Day 1. 10. Eastern Cooperative Oncology Group (ECOG) Score 0 or 1. 11. Baseline laboratory parameters must meet the following criteria:
• Haemoglobin ≥110 g/L
• White cell count ≥2.0×10^9/L
• Absolute neutrophil count ≥1.5×10^9/L
• Lymphocytes ≥0.9×10^9/L
• Platelets ≥100×10^9/L
• Creatinine ≤1.5×upper limit of normal (ULN) OR calculated creatinine clearance ≥50 mL/min by the Cockcroft Gault formula
• Total bilirubin ≤1.5×ULN, (total bilirubin >1.5×ULN is acceptable if total bilirubin is fractionated and direct bilirubin <35%)
• Alanine aminotransferase ≤1.5×ULN
• Aspartate aminotransferase ≤1.5×ULN
• Troponin T within normal range
• HbA1c <7 % 12. Agrees to the following during the trial for at least 65 days after the last dose of VTP-850:
• Refrain from donating sperm PLUS, either
• Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent OR
• Agrees to use a male condom when having sexual intercourse with a woman of childbearing potential, and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak. 13. Agrees to comply with all scheduled visits, VTP-850 administration plan, laboratory tests, lifestyle considerations and other trial procedures

Exclusion Criteria:

1. Any other prior malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
2. Unstable medical condition, drug or alcohol abuse, or medical or psychiatric condition that in the opinion of the investigator would affect the safety of the participant or the evaluation of the data or interfere with adherence to the trial requirements.
3. Significant history of or current cardiovascular, respiratory, renal, gastrointestinal, endocrinological, haematological or neurological disorders constituting a risk when taking the trial intervention or interfering with the interpretation of data; cardiac event or heart failure in the previous 6 months.
4. Current or chronic history of liver disease. This includes but is not limited to: hepatitis virus infections, cirrhosis, drug- or alcohol-related liver disease, non alcoholic steatohepatitis, autoimmune hepatitis, hemochromatosis, Wilson's disease, α-1 antitrypsin deficiency, primary biliary cholangitis, primary sclerosing cholangitis or any other liver disease considered clinically significant by the investigator. (Note that history of hepatitis C infection, Gilbert's syndrome or non alcoholic fatty liver not associated with steatohepatitis are not exclusions. In line with Exclusion Criterion 10, active hepatitis C infection is exclusionary.)
5. Active autoimmune disease that has required systemic treatment in past 2 years with use of disease modifying agents, chronic corticosteroids (>14 days) or immunosuppressive drugs. Hormone replacement therapy (e.g., thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is allowed.
6. History of severe allergy to eggs or history of severe reaction to any previous vaccination that required medical attention.
7. Medical history that could increase the participant's risk of reaction to a vaccine, including but not limited to capillary leak syndrome, transverse myelitis, multiple sclerosis, Guillain Barré syndrome, significant thrombocytopenia, thrombosis with thrombocytopenia syndrome (also termed vaccine-induced thrombotic thrombocytopenia), heparin-induced thrombocytopenia, or hereditary angioedema, acquired angioedema or idiopathic angioedema.
8. Any immunocompromised state, or history of solid organ or stem cell transplantation.
9. Active infection requiring parenteral antibiotic therapy or causing fever (temperature ≥38.0˚C) within 7 days prior to Day 1, or unexplained fever (temperature ≥38.0˚C) within 7 days prior to Day
10. Known history of infection with hepatitis B virus, or human immunodeficiency virus, or active hepatitis C virus infection (antibody and RNA positive).
11. Received XRT following radical prostatectomy within 6 months prior to Day
12. Received ADT outside of the initial primary therapy
13. Prior chemotherapy or immunotherapy (including vaccines or checkpoint inhibitors) or experimental agent or participation in a clinical trial for prostate cancer with the exception of those taking part as primary treatment option.
14. Received a vaccine with adenovirus vector within 3 months prior to Day
15. Received any live vaccine within 30 days prior to Day 1, or planned vaccination to occur within 3 months after Day
16. Received any non-live/inactivated vaccine within 14 days of Day 1 or planned non-live vaccination to occur within 10 weeks after Day
17. Administration of immunoglobulins and/or any blood products within 28 days prior to Day
18. Condition requiring systemic treatment with corticosteroids or other immunosuppressive medications within 14 days of first dose of VTP-8
19. Note that adrenal replacement doses are permitted. Inhaled and topical corticosteroids are allowed.
20. Received an investigational product or investigational surgical procedure in the 3 months prior to Day 1 or planned use during the trial period, or participation at any time in clinical trial for prostate cancer with exception of those taking part as primary treatment.
21. Any significant cardiovascular conditions per the investigator within 6 months before study entry including but not limited to: myocardial infarction, stroke, New York Heart Association class III or IV heart failure, thromboembolic events, major cardiovascular or cerebrovascular procedures, history of cardiac valvular disease or other structural heart disease or any other condition that in the investigator's opinion puts the participant at unacceptable risk to enter the study.
22. Participant with QT interval corrected for heart rate (QTc) determined using Fridericia's formula (QTcF; QTcF = QT/[R-R interval {RR}^0.33]) > 470 msec and any other ECG findings deemed clinically significant at screening.
23. Uncontrolled hypertension that, in the opinion of the Investigator, puts participant at increased risk of a cardiovascular event at the time of screening.
24. Uncontrolled dyslipidemia that, in the opinion of the Investigator, puts participant at increased risk of cardiovascular event at the time of screening.

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Condition: Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT06053658

Sponsor: M.D. Anderson Cancer Center

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

Inclusion Criteria:

• 1. Patients with histologically or cytologically confirmed metastatic non-clear cell renal cell carcinoma of papillary, chromophobe, oncocytic neoplasms, unclassified, or not otherwise specified (NOS) as clear cell. Medullary carcinoma of the kidney and collecting duct tumors are NOT allowed 2. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 3. Up to 1 systemic line of therapy (either monotherapy or combination) including prior immunotherapy (anti-PD1, PD-L1, or CTLA-4) and multi-tyrosine kinase inhibitors in non-metastatic or metastatic setting is allowed. A washout period of 5 half lives or 21 days, whichever one is shorter, will be required for patients that have received previous systemic therapy. 4. Age ≥18 years. 5. Eastern Cooperative Oncology Group (ECOG) Appendix 1 performance status ≤2 (Karnofsky ≥60%). 6. Patients must have adequate organ and marrow function as defined below: 1. absolute neutrophil count ≥1,000/mcL 2. platelets ≥100,000/mcL 3. total bilirubin ≤ institutional upper limit of normal (ULN) 4. AST ≤3 × institutional ULN 5. (ALT) ≤3 × institutional ULN 6. creatinine ≤1.5 × institutional ULN 7. eGFR ≥30 ml/min 7. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. 8. For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. 9. Patients with treated brain metastases (at least 4 weeks have passed from treatment) are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression. 10. Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy. 11. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. 12. Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better. 13. The effects of combination tivozanib and nivolumab on the developing human fetus are unknown. For this reason and because tyrosine kinase inhibitors and immunotherapy agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (refer to MDA Policy CLN 1114) This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:
• Postmenopausal (no menses in greater than or equal to 12 consecutive months).
• History of hysterectomy or bilateral salpingo-oophorectomy.
• Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
• History of bilateral tubal ligation or another surgical sterilization procedure. Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device, Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. 14. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of combination tivozanib and nivolumab administration. 15. Participants or their legally acceptable representative (LAR) must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal participant care.

Exclusion Criteria:

1. Prior tivozanib therapy.
2. Prior nivolumab therapy.
3. Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 1) with the exception of alopecia.
4. Patients who are receiving any other investigational agents.
5. History of allergic reactions attributed to compounds of similar chemical or biologic composition to tivozanib or nivolumab.
6. Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg on 2 or more antihypertensive medications, documented on 2 consecutive measurements taken at least 2 hours apart. Anti-hypertensives must not have been increased 30 days prior to enrollment.
7. History of autoimmune disorders except for the following:
8. Patients with vitiligo or alopecia
9. Hypothyroidism (e.g. following Hashimoto syndrome) that is stable on thyroid hormone replacement
10. Any chronic skin condition that does not require systemic therapy
11. Patients without active autoimmune disease requiring treatment in the last 3 years may be included after consultation with study MDA lead Principal Investigator
12. Active human immunodeficiency virus (HIV) infection unless patients are on effective anti-retroviral therapy with undetectable viral load within 6 months.
13. Has evidence of any other medical conditions, psychiatric condition, physical examination or laboratory findings that may interfere with the planned treatment, affect subject compliance or place the subject at high risk from treatment-related complications in the opinion of the local principal investigator (PI).
14. Current systemic corticosteroid use greater than prednisone 10 mg daily or equivalent.
15. Pregnant women are excluded from this study because tivozanib and nivolumab are agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with tivozanib and nivolumab, breastfeeding should be discontinued if the mother is treated with tivozanib and nivolumab.
16. Receiving concomitant CYP3A inducers.

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Condition: Prostate Carcinoma, Recurrent Prostate Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04857502

Sponsor: Jonsson Comprehensive Cancer Center

Phase: Early Phase 1

Eligibility:

• Age: minimum N/A maximum N/A
• Gender: Male

Inclusion Criteria:

• Men with PCa (primary or recurrent disease)
• Men who received a 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) for staging or restaging
• Men with evidence of lymph nodes (LNs)-positive disease on 68Ga-PSMA-11 PET/CT
• Men who are scheduled for pelvic LN dissection (PLND)
• Men who can provide oral and written informed consent
• Men who can comply with study procedures

Exclusion Criteria:

• Patients who started any PCa treatment between study enrollment and surgery
• Technically inaccessible nodal location

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Condition: Prostate Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT06128525

Sponsor: University of Southern California

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• Adult men diagnosed with prostate cancer and undergoing prostatectomy as treatment of choice
• Index lesion visible on multiparametric MRI confirmed by targeted biopsies using KOELIS Trinity (registered trademark)
• Patient suitable for intravenous (IV) sedation or general anesthesia and TMA
• Free, informed, and written consent, dated and signed before the enrollment and before any exam required by the trial

Exclusion Criteria:

• Past medical history of prostate surgery
• Past medical history of radiotherapy or pelvic trauma
• Past treatment for prostate cancer (PCa) (radiation, ablation, androgen deprivation therapy [ADT], chemotherapy)

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Condition: Malignant Neoplasm of Prostate

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT06437496

Sponsor: First Affiliated Hospital of Fujian Medical University

Phase: Early Phase 1

Eligibility:

• Age: minimum 18 Years maximum 90 Years
• Gender: Male

Inclusion Criteria:

• confirmed treated or untreated prostate cancer patients;
• 68Ga-AAZTA-093 and 68Ga-PSMA-11/68Ga-PSMA-617 PET/CT within 1 week;
• signed written consent.

Exclusion Criteria:

• known allergy against PSMA;
• any medical condition that in the opinion of the investigator may significantly interfere with study compliance.

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Condition: Prostate Cancer, Malignant Neoplasm of Prostate, Secondary Malignant Neoplasm of Prostate

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT06150417

Sponsor: Case Comprehensive Cancer Center

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• Participant must be ≥ 18 years of age.
• Participant must have an ECOG performance status ≤ 1.
• Histologic confirmation of prostate adenocarcinoma of the prostate gland, with evidence of metastasis on imaging by conventional imaging (MRI, CT, or 99mTc bone scan) or PSMA PET/CT. Biopsy of sites of metastasis is strongly encouraged, but not required.
• There must be at least 10-15 unstained slides from 2 cores of the highest tumor cellularity available.
• Newly diagnosed disease with no prior treatment to the primary disease.
• Acceptable to have started LHRH agonist or antagonist therapy alone within the past 30 days prior to enrollment.
• In participants who undergo only conventional imaging, oligometastatic disease is defined as 1-5 discrete metastatic sites in the bone and/or extra-pelvic lymph node (LN) stations.
• Extra-pelvic LN stations are superior to the regional/pelvic LN stations. Pelvic LN stations commence at the bifurcation of the aorta and bifurcation of the proximal inferior vena cava to the common iliac veins.
• Radiographic criteria for a LN to be considered a metastatic focus is defined as short-axis diameter in the axial plane of ≥ 1.0 cm, with irregular border and/or heterogeneous morphology
• In participants who undergo PSMA PET/CT (in the presence or absence of conventional imaging), oligometastatic disease is defined as 1-10 PSMA avid bone lesions and/or extra-pelvic LN stations. The MI-RADS reporting system will be followed to guide PSMA PET interpretation
• In participants extra-pelvic nodal (M1a) disease only by PSMA PET/CT and M0 by conventional imaging (i.e. extra-pelvic LN did not meet size criteria by CT), participant must meet 2 of 3 following criteria in order to be eligible:
• 1. PSA ≥ 40
• 2. Evidence of cN1 disease (pelvic LN)
• 3. Decipher score ≥ 0.89
• Adequate organ and marrow function to receive treatment per treating physician
• Medically fit for treatment and agreeable to follow-up.
• Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

• Participants with the presence of any of the following:
• Castration resistant prostate cancer (CRPC).
• Evidence of visceral or intracranial metastases.
• Participant receiving any other investigational agents for cancer.
• Participant is participating in a concurrent treatment protocol for cancer.
• Unable to lie flat during or tolerate PET/MRI, PET/CT or SBRT.
• Prior definitive treatment to the primary prostate cancer or pelvis.
• Participant with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled diabetes (HgA1c > 10), active pituitary or adrenal dysfunction, or psychiatric illness/social situations that would limit compliance with study requirements
• History of another active malignancy within the previous 2 years, except for non-melanoma skin cancer.
• Active Crohn's disease or ulcerative colitis despite medical management.
• Refusal to sign informed consent.
• Any condition that in the opinion of the investigator would preclude participation in this study

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Condition: Cancer Of Prostate

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05361798

Sponsor: National Cancer Institute (NCI)

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• Participants must have histologically or cytologically confirmed localized intermediate or high risk prostate cancer:
• Intermediate risk
• Gleason 7 disease, PSA less than 10
• High Risk
• Gleason 8-10, PSA>10, Extracapsular Extension
• Participants must require treatment with SBRT to the prostate and ADT.
• Pre-treatment tissue availability (collected <= 1 year to initiation of study therapy) for biomarker analysis is mandatory for enrollment. If tissue is determined to be of insufficient/unsuitable quality/quantity, a pre-treatment biopsy prior to initiation of study therapy will be required.
• Male age >= 18 years old
• ECOG performance status < 2
• Participants must have adequate organ and marrow function as defined below:
• absolute neutrophil count >= 1,500/mcL, without CSF support
• platelets >= 100,000/mcL
• AST(SGOT)/ALT(SGPT) <= 2.5 X institutional upper limit of normal
• Hgb >= 10g/dL (pRBC transfusions are not allowed to achieve acceptable Hgb)
• Total bilirubin <= 1.5 x upper limit of normal (ULN), OR in participants with Gilbert s syndrome, a total bilirubin <= 3.0
• Serum albumin >= 2.8 g/dL
• Creatine <= 1.5 X institutional ULN OR
• Creatinine clearance >= 50 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal by 24h urine
• PT/INR and aPTT <= 1.5 X institutional ULN
• Testosterone greater than 100 ng/dL.
• Men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) after study entry and for 6 months after completion of radiation treatment or immunotherapy (if taken, whatever is last)
• Participants must have prostate cancer accessible for biopsy
• Ability of participant to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• Evidence of distant metastatic disease (including clinically or pathologically positive lymph nodes or metastatic disease outside of the pelvis).
• Previous prostatectomy, focal therapy, or radiation to the prostate. Note: Previous finasteride, dutasteride, bicalutamide are allowed at PI discretion.
• Initiation of ADT or SBRT or pelvic nodal radiation irradiation prior to trial enrollment (no time limit).
• Live vaccine therapies for the prevention of infectious disease within 30 days prior to treatment administration. Seasonal flu vaccines that do not contain a live virus are permitted. Locally approved COVID vaccines are permitted.
• Contraindication to mpMRI including allergy or sensitivity to contrast agents (which cannot be alleviated by premedication)
• Contraindications for SBRT such as: rectal wall invasion, history of inflammatory bowel disease, prior radiation in the treatment field that would exceed tissue tolerance.
• Medical comorbidities that preclude the administration of androgen deprivation therapy or uncontrolled chronic or acute intercurrent illness /social situations or other illnesses considered by the Investigator as high risk for investigational drug treatment
• Participants with active immune deficiencies, chronic inflammatory conditions, active autoimmune diseases, or participants on chronic immunosuppressive therapy for whom the primary endpoint of immune response could be impacted.
• Participants requiring requiring systemic corticosteroids (>10 mg daily prednisone equivalent) or immunosuppressive medications except inhaled steroids and adrenal replacement steroid doses up to 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Participants with a history of autoimmunity that has not required systemic immunosuppressive therapy or dose not threaten vital organ function including CN, heart, lungs, kidneys, skin and GI track will be allowed
• Participants with HIV
• Active Hepatitis B or Hepatitis C infection
• Significant acute or chronic infections including tuberculosis (history of exposure or history of positive tuberculosis test; plus, presence of clinical symptoms, physical or radiographic findings)
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to M9241.
• Participants with prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast or low risk Gleason 6 prostate cancer.

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Condition: Cancer of Prostate

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT06318559

Sponsor: Fondazione del Piemonte per l'Oncologia

Eligibility:

• Age: minimum 40 Years maximum 99 Years
• Gender: Male

Inclusion Criteria:

1. Signature of the written informed consent and consent to the use of personal data
2. Age > 40 years and male sex
3. Pre-operative MRI performed according to ESUR recommendations and reporting in accordance with PiRads V.2
4. Disease with evidence of bulging or radiological T3 on pre-operative MRI
5. Histological diagnosis of acinar type prostate cancer in the area highlighted on MRI
6. Absence of bulky (>3 cm), bony or visceral retroperitoneal or pelvic lymph node metastatic lesions
7. Patients eligible for radical prostatectomy + pelvic lymphadenectomy
8. ECOG PS 0-1
9. Life expectancy ≥ 5 years
10. Patients motivated to preserve erection and with pre-operative sexual activity with IIEF >17
11. Availability of the patient's pre-operative clinical data
12. Patients must be available to carry out the visits foreseen in the follow-up of the protocol and consent to data collection

Exclusion Criteria:

1. Special histotypes of prostate cancer
2. Patients with PSA > 100 ng/ml at diagnosis
3. Inability to perform MRI (pacemaker wearers, claustrophobia...) or MRI of inadequate quality to obtain the HA3DTM 3D reconstruction
4. Concomitant treatment with other antineoplastic drugs including investigational endocrine therapies
5. Serious uncontrolled concomitant medical condition or disease including active, uncontrolled infections
6. Patients with dementia or psychiatric illness that limit compliance with study requirements or that may prevent understanding and/or signing informed consent.

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Condition: Local Recurrence of Malignant Tumor of Prostate

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03438552

Sponsor: UNICANCER

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• Biochemical recurrence occurring at least 2 years after external radiotherapy for prostatic adenocarcinoma by the Phoenix definition (PSA nadir + 2 ng/mL)
• T1-T2c and PSA ≤20 ng/mL and Gleason score ≤7 at initial diagnosis of prostate cancer before the initial/first treatment.
• Recurrence of prostatic adenocarcinoma proven by histology following radiotherapy by transrectal or transperineal sextant biopsies of the two lobes of the prostate, with a minimum of 12 biopsies, irrespective of Gleason score. Biopsies of the seminal vesicles are optional.
• Clinical stage T1-T2 on relapse; unilateral extracapsular extension (T3a) on MRI permitted except posteriorly relative to the rectum
• Estimated clinical target volume (CTV) / prostate volume < 0.5 based on imaging and biopsies
• Pelvic and prostatic assessment by multiparametric MRI- Absence of pelvic or metastatic recurrence proven by choline PET scan
• Performance status World Health Organization (WHO) 0-1
• PSA level ≤10 ng/mL at baseline (before salvage-SBRT)
• PSA doubling time >10 months
• International Prostate Cancer Score (IPSS) ≤12
• Uroflowmetry with a maximum flow rate >10 mL/s, a postvoid residual urine volume <150 mL, and a urine volume >150 mL.
• No other anti-cancer treatment since the external radiotherapy administered as first-line treatment
• No other anti-cancer treatment planned for the current recurrence
• No contraindication to fiducial marker implants; haemostatic disorders must be corrected before implantation
• Age >18 years
• Life-expectancy greater than or equal to 5 years (Lee scale)
• Patient registered with a health insurance system
• Patient who has signed the informed consent form
• Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests, and other study procedures indicated in the protocol.

Exclusion Criteria:

• Lymph node or metastatic spread
• Late post-radiotherapy urinary or gastrointestinal toxicity of grade ≥2 (following primary radiotherapy)
• Other cancers in the last 5 years except for non-melanoma-type skin cancer
• History of inflammatory bowel disease
• Anticoagulant treatment
• Contraindications to undergoing MRI
• Prostate volume >80 cc
• Transurethral resection of the prostate (TURP) in the 6 months before registrations
• Presence of rectal telangiectasia grade 3 classified by the Vienna Rectoscopy Score (obligatory rectoscopy)
• Previous rectal surgery
• Patients unable to undergo medical follow-up in the study for geographical, social or psychological
• Person deprived of their liberty or under protective custody or guardianship
• Patients enrolled in another therapeutic study All patients during the SBRT planning with a ratio of clinical target volume (CTV) / prostate volume >0.5 will be withdrawn from the study. These patients will be considered as not evaluable and will not be treated within the context of the study.

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Condition: Primary Malignant Neoplasm of Prostate (Diagnosis)

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT04797039

Sponsor: Mayo Clinic

Phase:

Eligibility:

• Age: minimum 30 Years maximum 100 Years
• Gender: Male

Inclusion Criteria:

• Patients with "biopsy proven" Gleason7 prostate cancer referred to Urology and/or Interventional Radiology for treatment
• Surgery and/or Radiation is not a desirable alternative therapy at the time of enrollment
• Tumor size is < 2 cm at its largest diameter
• Tumor does not encompass the rectal wall or external urethral sphincter
• Patient is able to undergo MRI

Exclusion Criteria:

1. •

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Condition: Prostatic Neoplasm, Prostatic Cancer

Study Type: Observational [Patient Registry]

Clinical Trials Identifier NCT 8-digits: NCT04484701

Sponsor: British Columbia Cancer Agency

Phase:

Eligibility:

• Age: minimum 19 Years maximum 99 Years
• Gender: Male

Inclusion Criteria:

• Eastern Cooperative Oncology Group performance status of 2 or less.
• Subjects with high risk prostate cancer (CAPRA score 6 or higher) being considered for curative-intent surgery or radiation therapy (including brachytherapy)
• Subjects with biopsy confirmed prostate cancer being considered for curative-intent surgery or radiation therapy (including brachytherapy), who have unconfirmed suspicious findings on conventional medical imaging staging examinations.
• Subjects with biochemical recurrence or persistence of prostate cancer following initial curative treatment by radical prostatectomy, with two consecutive PSA values >0.2 ng/ml measured more than 6 weeks after radical prostatectomy. If subjects received subsequent systemic therapy, the most recent PSA measurement prior to PET/CT imaging must be greater than 0.2 ng/mL.
• Subjects with biochemical recurrence or persistence of prostate cancer following initial curative treatment by radical prostatectomy and subsequently treated by salvage radiotherapy or pelvic node dissection, with two consecutive PSA values >0.2 ng/ml. If subjects received subsequent systemic therapy, the most recent PSA measurement prior to PET/CT imaging must be greater than 0.2 ng/mL.
• Subjects with biochemical recurrence of prostate cancer after initial curative therapy with radiation therapy (including brachytherapy), or non-standard local ablative therapy (such as high frequency ultrasound, cryoablation, focal laser ablation, etc.), with a PSA level >2 ng/mL above the nadir after radiation therapy.
• Subjects with advanced castration sensitive or castration resistant prostate cancer being considered for localized treatment (surgery, brachytherapy, radiotherapy) of recurrent or oligometastatic prostate cancer. Castration resistance is defined as a PSA level > 1.0 ng/mL, with 2 consecutive rises above the nadir, in the presence of castrate levels of testosterone (< 1.7 nmol/L).
• Subjects with metastatic or castration resistant prostate cancer being evaluated for systemic therapy administered in therapeutic clinical trials. The PSA level must be > 1.0 ng/mL, with 2 consecutive rises above the nadir, in the presence of castrate levels of testosterone (< 1.7 nmol/L). Exclusion Criteria:
• Medically unstable (e.g. acute illness, unstable vital signs)
• Unable to lie supine for the duration of imaging
• Unable to provide written consent
• Exceeds safe weight limit of the PET/CT bed (204.5 kg) or unable to fit through the PET/CT bore (diameter 70 cm)

Exclusion Criteria:

• Medically unstable (e.g. acute illness, unstable vital signs)
• Unable to lie supine for the duration of imaging
• Unable to provide written consent
• Exceeds safe weight limit of the PET/CT bed (204.5 kg) or unable to fit through the PET/CT bore (diameter 70 cm) Exclusion criteria for the use of furosemide Subjects can still participate in the research study and undergo the [68Ga]Ga-PSMA-11 scan if they are unable or unwilling to receive a furosemide injection.
• Subjects with end stage renal disease.
• Subjects with documented history of severe progressive chronic kidney disease (glomerular filtration rate less than 30 mL/min/1.73 m2).
• Subjects with hypersensitivity to furosemide (Lasix).
• While cross-reactivity between sulfonamide antibiotics and non-antibiotics has been disproven, subjects who have a history of sulfonamide antibiotics or sulfonylureas may be at a higher risk of allergic reaction to furosemide due to a higher general predisposition to allergic reactions. In those instances, the administration of furosemide is left at the discretion of the local site investigator after discussion with the study subject.
• Subjects with severe hypokalemia, hyponatremia, hypovolemia, dehydration or hypotension.
• Subjects with untreated bladder outlet obstruction or lower urinary tract symptoms, who have a history of obstructive episodes that required hospitalization, emergency department visits and/or bladder catheterization for relief of symptoms.

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Condition: Prostatic Neoplasms

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05714774

Sponsor: Hospices Civils de Lyon

Eligibility:

• Age: minimum 50 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• Patient who has been clearly informed of the study and has agreed, with sufficient time for reflection, to participate by signing the study informed consent form.
• Male aged ≥ 50 years,
• PSA ≤ 15 ng/mL
• diagnosis of localized prostate cancer (stage T1 or T2) with a Gleason score of ≤ 7
• Focal, hemiablation or ablation HIFU treatment validated in Multidisciplinary Concerted Meeting
• Patient enrolled in Medicare or equivalent plan.
• Interpretable preoperative multiparametric MRI performed within 180 days prior to surgery

Exclusion Criteria:

• an ASA score >3
• brachytherapy for prostate cancer
• Person of full age protected by law (person under guardianship or curatorship).
• Contraindication to HIFU treatment as defined in the Focal One instructions for use :
• Multiple intraprostatic calcifications inducing, on ultrasound, a shadow cone in the prostate preventing the penetration of ultrasound and therefore the realization of the treatment.
• Presence of permanent radioactive implants in the rectal wall.
• Presence of an implant (stent, catheter) located less than 1 cm from the treatment area.
• Fistula of the urinary tract or rectum.
• Anal or rectal fibrosis, anal or rectal stenosis or other abnormalities making insertion of the Focal One® catheter difficult.
• Anatomical abnormality of the rectum or rectal mucosa.
• Patient with an artificial sphincter, penile prosthesis or intraprostatic implant, such as a stent.
• History of inflammatory bowel disease.
• Current urogenital infection (infection should be treated prior to HIFU treatment).
• Patient allergic to latex with known severe reactionsCounter-indications to anesthesia

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Condition: Prostate Cancer, Cancer of Prostate

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04887935

Sponsor: Washington University School of Medicine

Phase: Phase 1

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• Histologically or cytologically confirmed localized prostatic adenocarcinoma. Patients with primarily neuroendocrine/small cell histology will be excluded.
• Patients with high risk or very high risk prostatic adenocarcinoma as defined by NCCN criteria.
• High risk is defined by NCCN as meeting at least one of the following criteria:
• T3a
• grade group 4 or 5
• PSA > 20
• Very high risk is defined by NCCN as meeting at least one of the following criteria:
• T3b-T4
• primary Gleason pattern 5
• 2-3 high risk features **> 4 cores with grade group 4 or 5
• Willing and able to undergo prostate MRI at baseline, with a measurable prostate lesion present.
• Planning to undergo radical prostatectomy as primary treatment for localized prostate cancer.
• At least 18 years of age.
• ECOG performance status ≤ 1
• Adequate bone marrow and organ function as defined below:
• Leukocytes ≥ 3.0 K/cumm
• Absolute neutrophil count ≥ 1.5 K/cumm
• Platelets ≥ 100 K/cumm
• Total bilirubin ≤ 1.5 x institutional upper limit of normal (IULN)
• AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
• Estimated glomerular filtration rate eGFR ≥ 30 mL/min/1.73m^2
• Agreement to adhere to Lifestyle Considerations throughout study duration
• Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria:

• Current or previous treatment with SGLT2i or thiazolidinedione.
• Currently receiving regularly scheduled systemic steroids in the form of prednisone or dexamethasone (more than 10 mg prednisone daily or equivalent). Topical steroid ointments or creams for occasional skin rash is allowed.
• A history of other malignancy with the exceptions of malignancies for which all treatment was completed at least 2 years before registration with no evidence of disease and locally treated skin squamous or basal cell carcinoma.
• History of stroke or transient ischemic attack in the last 5 years.
• Patients with type 1 diabetes mellitus will be excluded or patients with insulin-requiring diabetes mellitus will be excluded. Only patients with well-controlled type 2 diabetes mellitus will be allowed.
• Screening HbA1c > 10%, unless approved by endocrinologist.
• Currently receiving any other investigational agents.
• A history of allergic reactions attributed to compounds of similar chemical or biologic composition to dapagliflozin.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, peripheral arterial disease, ketoacidosis, severe kidney disease (estimated glomerular filtration rate eGFR < 30 mL/min/1.73m2), symptomatic hypotension, and chronic/frequent urinary tract infections or yeast infections.
• Patients with HIV are eligible unless their CD4+ T-cell counts are < 350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended.
• Any evidence of pelvic instrumentation (i.e. hip arthroplasty) that would obscure and/or limit prostate MRI evaluation at the discretion of the investigator, or any type of medical device that would be incompatible with MRI imaging.

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Condition: Prostatic Neoplasms

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT03805919

Sponsor: National Cancer Institute (NCI)

Phase:

Eligibility:

• Age: minimum 30 Years maximum 75 Years
• Gender: Male

Inclusion Criteria:

• Persons assigned male at birth between the ages of 30-75 years.
• Documented germline variant (i.e. pathogenic/likely pathogenic variant) in prostate cancer risk-related gene from a CLIA certified laboratory: BRCA1 and BRCA2, MMR genes (MLH1, MSH2, MSH6, PMS2, and EPCAM) associated with Lynch syndrome, as well as HOXB13, ATM, NBN, TP53, CHEK2, PALB2, RAD51C, RAD51D, BRIP1, or FANC (FANCA, FANCB, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCI, FANCL, and FANCM).
• Prognosis of >5 years survival if affected by another cancer
• Ability of subject to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

• Prior diagnosis or treatment for prostate cancer
• Known contraindication to MRI:
• Participants unable to fit through MRI scanner (radiologist discretion)
• Allergy to MR contrast agent
• Participants with pacemakers, cerebral aneurysm clips, shrapnel injury, or implantable electronic device
• Active concomitant medical or psychological illnesses that may increase the risk to the subject or inability to obtain informed consent, at the discretion of the principal investigator.

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