Prostate Cancer

Condition: Prostate Cancer, Localized Malignant Neoplasm

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT01766492

Sponsor: Georgetown University

Phase:

Eligibility:

• Age: minimum 18 Years maximum 99 Years
• Gender: Male

Inclusion Criteria:

• Histologically confirmed adenocarcinoma of prostate
• Signed study-specific consent
• Prostate Specific Antigen (PSA) within 60 days of registration

Exclusion Criteria:

• Prior pelvic radiotherapy
• Prior radical prostate surgery
• Medical or psychiatric illness that would interfere with treatment or follow up
• Implanted hardware adjacent to the prostate that would prohibit appropriate treatment planning and/or treatment delivery

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Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03574571

Sponsor: Memorial Sloan Kettering Cancer Center

Phase: Phase 3

Eligibility:

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

Inclusion Criteria:

• Willing and able to provide written informed consent (ICF) and HIPAA authorization for the release of personal health information. A signed informed consent must be obtained before screening procedures are performed. NOTE: HIPAA authorization may be either included in the informed consent or obtained separately.
• Males 18 years of age and above
• Histological or cytological proof of prostate cancer
• Documented progressive mCRPC based on at least one of the following criteria: 1. PSA progression defined as 25% increase over baseline value with an increase in the absolute value of at least 1.0 ng/mL that is confirmed by another PSA level with a minimum of a 1 week interval and a minimum PSA of 1.0 ng/mL. 2. Soft-tissue progression defined as an increase ≥ 20% in the sum of the LD of all target lesions based on the smallest sum LD since treatment started or the appearance of one or more new lesions. 3. Progression of bone disease (evaluable disease) or two or more new bone lesions by bone scan.
• Two or more bone lesions
• ECOG 0- 1
• Normal organ function with acceptable initial laboratory values within 14 days of randomization:
• Albumin > 30 g/L
• ANC ≥ 1.5 x 10^9/L
• Hemoglobin ≥ 10 g/dL
• Platelet count ≥ 100 x 10^9/L
• Creatinine ≤ 1.5 x the institutional upper limit of normal (ULN)
• Bilirubin ≤ ULN (unless documented Gilbert's disease)
• SGOT (AST) ≤ 1.5 x ULN
• SGPT (ALT) ≤ 1.5 x ULN
• WBC count ≥ 3 x 10^9/L
• Subjects must agree to use a medically acceptable method of birth control (e.g., spermicide in conjunction with a barrier such as a condom) or sexual abstinence for the duration of the study, including 30 days after the last dose of study drug. Sperm donation is prohibited during the study and for 30 days after the last dose of study drug. Female partners must use hormonal or barrier contraception unless postmenopausal or abstinent.
• Serum testosterone < 50 ng/dL. Subjects must continue primary androgen deprivation with an LHRH analogue (agonist or antagonist) if they have not undergone orchiectomy.
• All acute toxic effects of any prior treatment have resolved to NCI-CTCAE v4.0 Grade 1 or less.
• Willing and able to comply with the protocol, including follow-up visits and examinations

Exclusion Criteria:

• Received any other investigational therapeutic agents or other anticancer therapies within 4 weeks prior to randomization.
• Received external beam radiotherapy within the 4 weeks prior to randomization.
• Has an immediate need for external beam radiotherapy.
• Has received any systemic bone-seeking radiopharmaceutical in the past.
• Has received any prostate cancer directed chemotherapy in the castration resistant setting. Subjects who have received up to 6 prior doses of docetaxel in the castration sensitive setting are permitted if they have not experienced disease progression within 36 weeks of last treatment with docetaxel.
• Has received four or more systemic anticancer regimens for mCRPC.
• Treatment with docetaxel or abiraterone for non-castrate metastatic disease is permissible and does not count towards the lines of therapy for mCRPC
• A 'line' is a regimen. Combinations of hormones and other types of therapies count as single lines.
• Has known Grade ≥3 docetaxel-related toxicities or docetaxel toxicity related dose interruption or discontinuation.
• Has received blood transfusions or growth factors within the last 4 weeks prior to randomization.
• Symptomatic nodal disease (i.e., scrotal, penile, or leg edema).
• Has visceral metastases with ≥ 3 lung and/or liver metastases or individual lesion ≥2 cm, as assessed by CT scan or MRI of the chest/abdomen/pelvis within the last 8 weeks prior to randomization.
• Symptomatic loco-regional disease that causes ongoing Grade 3 or Grade 4 urinary or rectal symptoms.
• Subjects with a "currently active" second malignancy other than non-melanoma skin cancers or non-invasive bladder cancers or other in-situ or non-invasive malignancies. Subjects are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for ≥ 3 years.
• Has imminent or established cord compression based on clinical findings and/or MRI.
• Known bone marrow dysplasia
• Has received any of the following in the 4 weeks prior to randomization: 5-alpha-reductase inhibitors, herbal medications, natural hormonally active foods (e.g., phytoestrogens) or other food supplements known to alter PSA in humans
• Any other serious illness or medical condition that would, in the opinion of the investigator, make this protocol unreasonably hazardous, including but not limited to:
• Uncontrolled infection
• NYHA III or IV heart failure
• Crohn's disease or those with ulcerative colitis who have not undergone a colectomy
• Known active infection with HIV, Hepatitis B or Hepatitis C

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Condition: Castration-resistant Prostate Cancer, Homologous Recombination Deficiency

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03522064

Sponsor: St Vincent's Hospital, Sydney

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

1. Males with histologically confirmed adenocarcinoma of the prostate
2. Confirmed HRD (Homologous recombination defect) in germline and/or somatic DNA analysis (tumour or blood), by a validated assay (see Appendix 1). Mutations in HR genes not listed in appendix 1 will be considered in literature suggests pathogenicity. A maximum of 10 uncharacterised or heterozygous mutations will be included.
3. Age ≥ 18 years
4. ECOG performance status ≤ 1
5. Rising PSA confirmed on two sequential tests ≥1 week apart and a minimum value of 2 ug/L despite castrate levels of testosterone
6. Serum testosterone < 1.7 nmol/L and on an LHRH agent or post orchidectomy ≥ 1 year.
7. Washout of ≥ 4 weeks from prior line of treatment, radiotherapy or surgery (aside from LHRH agent)
8. Adequate bone marrow function (platelets > 100 x 109/L, ANC > 1.5 x 109/L, Hb >100)
9. Adequate liver function (ALT/AST < 1.5 x ULN, bilirubin < 2 x ULN)
10. Adequate renal function (creatinine clearance > 50 ml/min)
11. Adequate cardiac function and reserve after cardiology assessment
12. Archived tissue sample available or willingness to undergo fresh biopsy
13. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments
14. Signed, written informed consent

Exclusion Criteria:

1. Contraindications to investigational product
2. Pain due to metastatic prostate cancer requiring opioid analgesics
3. Evidence of disease progression in sites or extent that, in the opinion of the investigator, would put the patient at risk from testosterone therapy and its potential for initial tumour flare (eg: femoral metastasis at risk of fracture, ureteric obstruction due to nodal disease or cord compression due to spinal metastases).
4. Previous treatment with platinum chemotherapy and/or a PARP inhibitor. However up to 8 men with prior treatment to these agents will be included as an exploratory cohort.
5. Life expectancy of less than 3 months.
6. Brain metastases or leptomeningeal disease
7. History of thromboembolic event and not currently on anticoagulation
8. Prior myocardial infarction or unstable angina within 2 years of study entry
9. Haematocrit ≥ 50%, untreated severe obstructive sleep apnoea or poorly controlled heart failure (NYHA >1)
10. History of another malignancy within 5 years prior to registration. Patients with a past history of adequately treated carcinoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or superficial transitional cell carcinoma of the bladder are eligible. Patients with a history of other malignancies are eligible if they have been continuously disease free for at least 5 years after definitive primary treatment.
11. Concurrent illness, including severe infection that may jeopardize the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety.
12. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse.

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Condition: Prostate Adenocarcinoma, Prostate Cancer, Localized Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03821246

Sponsor: Lawrence Fong

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

• 1. Histologically confirmed adenocarcinoma of the prostate. a. Subjects with small cell or neuroendocrine PC are not eligible. 2. Eligible for radical prostatectomy as determined by urologic oncology surgeon, and subject consents to proceeding with radical prostatectomy. a. Deemed by urologic oncology surgeon to be appropriate for a "window-of-opportunity"study. 3. Only patients with high-risk disease are eligible for the safety lead-in for each cohort. Patients with intermediate-risk disease will be included after interim analyses is complete for the corresponding cohort and the PI has determined that it is safe to do so. 4. Availability of a representative tumor specimen that is suitable for the planned study analyses, as determined by the Principal Investigator. 1. A formalin-fixed paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or at least 15 slides containing unstained, freshly cut, serial sections should be submitted along with an associated pathology report prior to study treatment. If only 10-14 slides are available, the patient may still be eligible for the study, after Principal Investigator approval has been obtained. 2. If archival tumor tissue is unavailable or is determined to be unsuitable for required testing, tumor tissue must be obtained from a biopsy performed at screening. Refer to Section 6.3 for additional information on tumor specimens collected at screening. 5. Subjects have not received any prior systemic or locally directed therapy for PC (see exclusion criteria). 6. Age >= 18 years 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 8. Requirements for organ and marrow function:
• Hemoglobin >= 9 g/dL
• Participants must not have been transfused within 2 weeks prior to screening to meet this criterion
• Absolute neutrophil count >= 1,500/microliter (uL) without granulocyte colonystimulating factor support
• Absolute lymphocyte count >= 500/uL
• Platelets >= 100,000/uL without transfusion
• Total bilirubin < 1.5 x institutional upper limit of normal (ULN) (known Gilbert disease: < 3 x ULN)
• Alkaline phosphatase < 2 x institutional ULN
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase (SGOT)) =< 2 x institutional ULN
• Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase (SGPT)) =< 2 x institutional ULN
• International normalized ratio (INR) or activated partial thromboplastin time (aPTT) < 1.5 x institutional ULN for subjects not receiving therapeutic anticoagulation
• Creatinine clearance >= 30 mL/min (calculated using the Cockcroft-Gault formula)
• Serum creatinine <=1.6 mg/dL (141 μmol/L) in female patients and ≤1.9 mg/dL (168 μmol/L) in male patients . Patients with serum creatinine values exceeding limits may be eligible for the study if their estimated glomerular filtration rates (GFR) are >30 9. Testosterone level > 150 ng/dL. 10. Contraception: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm as defined below: 1. With female partners of childbearing potential: men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of < 1% per year during the treatment period and for 4 months after the last dose of study treatment. Men must refrain from donating sperm during the same period 2. With pregnant female partners: men must remain abstinent or use a condom during the treatment period and for 4 months after the last dose of study treatment to avoid exposing the embryo 3. Abstinence: the reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception 11. For patients receiving therapeutic anticoagulation: stable anticoagulant regimen > 3 months. 12. Ability to understand a written informed consent document, and the willingness to sign it. 13. Ability to comply with the study protocol, in the investigator's judgment. Exclusion Criteria: 1. Evidence of metastatic disease as determined by standard staging scans. a. Staging scans should be performed per urologic standard of care for patients undergoing radical prostatectomy [per American Urological Association (AUA)/National Comprehensive Cancer Network (NCCN) guidelines]. 2. Not a candidate for radical prostatectomy as determined by treating urologic oncology surgeon. 3. Any prior systemic therapy for PC, including antiandrogens, androgen deprivation therapy [gonadotropin-releasing hormone (GnRH) agonist or antagonist], chemotherapy, targeted therapy, immunotherapy, OR radiopharmaceuticals. a. Subjects who are on finasteride or dutasteride must discontinue therapy and undergo a washout period of 6 weeks to become eligible for the study. Screening procedures should begin following the washout period. 4. Prior radiotherapy for PC. 5. Any history of prior malignancy, except: 1. Non-melanoma skin cancer treated with curative intent 2. Carcinoma-in-situ (CIS) treated with curative intent, without evidence of recurrence or disease progression for 3 years 3. Appropriately treated Stage I uterine cancer 4. All other cancer: treated with curative intent and without evidence of disease on standard of care follow-up for 5 years 6. Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjogren's syndrome, Guillain-Barre syndrome, or multiple sclerosis, with the following exceptions: 1. Subjects with a history of autoimmune-related hypothyroidism who are on thyroid-replacement therapy, with a stable dose > 3 months, are eligible for the study 2. Subjects with controlled type 1 diabetes mellitus who are on an insulin regimen, with a Glycated hemoglobin (hemoglobin A1C) < 7.0 are eligible for the study. All subjects with controlled type 2 diabetes mellitus are eligible for the study 3. Subjects with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded from the study) are eligible for the study provided all of the following conditions are met:
• Rash covers < 10% of body surface area
• Disease is well controlled at baseline and requires only low-potency topical steroids
• No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months 7. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or any evidence of active, non-infectious pneumonitis requiring corticosteroids. 8. History of prior positive human immunodeficiency virus (HIV) test. 9. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (chronic or acute). 1. Subjects with a past or resolved HBV infection are eligible for this study. 2. HCV positivity is defined as having a positive HCV antibody test followed by a positive HCV ribonucleic acid (RNA) test at screening; the HCV RNA test will only be performed for subjects who have a positive HCV antibody test. 10. Significant cardiovascular disease, such as New York Heart Association class III or greater cardiac disease, myocardial infarction, or cerebrovascular accident within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina. 11. Active chronic obstructive pulmonary disease (COPD) requiring use of home oxygen (O2) or systemic steroid therapy > 10 mg prednisone (or equivalent) daily. 12. Asthma requiring systemic corticosteroids > 10 mg prednisone (or equivalent) daily. Inhaled corticosteroids for the treatment of asthma are permitted. 13. Major surgical procedure (including joint surgery) other than for diagnosis within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the course of the study. a. Placement of central venous access catheter (e.g., port or similar) is not considered a major surgical procedure and is therefore permitted. 14. Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia. 15. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications. 16. Prior allogeneic stem cell or solid organ transplantation. 17. Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during the course of the study or within 5 months after the last dose of atezolizumab. Note: Because IL-6 inhibition may interfere with the normal immune response to new antigen, patients should be brought up to date on all recommended vaccinations, except for live vaccines, prior to initiation of therapy with tocilizumab to maximize vaccine response. 18. Treatment with investigational therapy within 28 days prior to initiation of study treatment. 19. Prior treatment with adenosine-axis inhibitors, cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies, including anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), ant-PD-1, and anti-PD-L1 therapeutic antibodies. 20. Treatment with systemic immunostimulatory agents [including, but not limited to, interferon and interleukin 2 (IL-2)] within 4 weeks or five half-lives of the drug (whichever is longer) prior to initiation of study treatment. 21. Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor (TNF)- agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the course of the study, with the following exceptions: 1. Patients who receive acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study 2. Patients who receive mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma (=< 10 mg prednisone or equivalent), or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency (=< 10 mg prednisone or equivalent) are eligible for the study. 22. History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins. 23. Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation. 24. Known allergy or hypersensitivity to any of the study drugs of their excipients. 25. Previous treatment with any cell-depleting therapies, including investigational agents or approved therapies, some examples include: CAMPATH, anti-cluster of differentiation 4 (CD4), anti-cluster of differentiation 5 (CD5), anti-cluster of differentiation 3 (CD3), anti-Cluster of Differentiation 19 (CD19) and anti-Cluster of Differentiation 20 (CD20) within 5 years prior to first dose of study treatment. 26. Treatment with intravenous gamma globulin, plasmapheresis or Prosorba column within 6 months of baseline. 27. Previous treatment with tocilizumab (an exception to this criterion may be granted for single dose exposure upon application to the Sponsor-Investigator on a case-by-case basis). 28. Any previous treatment with alkylating agents such as chlorambucil, or with total lymphoid irradiation within 5 years prior to first dose of study treatment. 29. History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies. 30. Evidence of serious uncontrolled concomitant, nervous system, pulmonary, renal, hepatic, endocrine (include uncontrolled diabetes mellitus) or gastrointestinal disease (including complicated diverticulitis, ulcerative colitis, or Crohn's disease). 31. Any history of recent serious bacterial, viral, fungal, or other opportunistic infections. 32. Primary or secondary immunodeficiency (history of or currently active) unless related to primary disease under investigation. 33. Any medical or psychological condition that in the opinion of the principal investigator would interfere with safe completion of the trial. 34. Pregnant women or nursing (breast feeding) mothers. 35. Neuropathies or other conditions that might interfere with pain evaluation unless related to primary disease under investigation. 36. Patients with lack of peripheral venous access Additional Exclusion Criteria for Cohort B (atezolizumab + etrumadenant): 37. Treatment with known P-glycoprotein (P-gp) substrates with a narrow therapeutic window, administered orally (e.g., digoxin) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment. 38. Treatment with known strong CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, phenobarbital, and St. John's Wort) and strong CYP3A4 inhibitors (eg,clarithromycin, grapefruit juice, itraconazole, ketoconazole, posaconazole, telithromycin,and voriconazole) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment. 39. Treatment with known breast cancer resistance protein (BCRP) substrates with a narrow therapeutic window, administered orally (e.g., prazosin, rosuvastatin) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment. Additional

Exclusion Criteria:

• ). 6. Age >= 18 years 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 8. Requirements for organ and marrow function:
• Hemoglobin >= 9 g/dL
• Participants must not have been transfused within 2 weeks prior to screening to meet this criterion
• Absolute neutrophil count >= 1,500/microliter (uL) without granulocyte colonystimulating factor support
• Absolute lymphocyte count >= 500/uL
• Platelets >= 100,000/uL without transfusion
• Total bilirubin < 1.5 x institutional upper limit of normal (ULN) (known Gilbert disease: < 3 x ULN)
• Alkaline phosphatase < 2 x institutional ULN
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase (SGOT)) =< 2 x institutional ULN
• Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase (SGPT)) =< 2 x institutional ULN
• International normalized ratio (INR) or activated partial thromboplastin time (aPTT) < 1.5 x institutional ULN for subjects not receiving therapeutic anticoagulation
• Creatinine clearance >= 30 mL/min (calculated using the Cockcroft-Gault formula)
• Serum creatinine <=1.6 mg/dL (141 μmol/L) in female patients and ≤1.9 mg/dL (168 μmol/L) in male patients . Patients with serum creatinine values exceeding limits may be eligible for the study if their estimated glomerular filtration rates (GFR) are >30 9. Testosterone level > 150 ng/dL. 10. Contraception: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm as defined below: 1. With female partners of childbearing potential: men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of < 1% per year during the treatment period and for 4 months after the last dose of study treatment. Men must refrain from donating sperm during the same period 2. With pregnant female partners: men must remain abstinent or use a condom during the treatment period and for 4 months after the last dose of study treatment to avoid exposing the embryo 3. Abstinence: the reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception 11. For patients receiving therapeutic anticoagulation: stable anticoagulant regimen > 3 months. 12. Ability to understand a written informed consent document, and the willingness to sign it. 13. Ability to comply with the study protocol, in the investigator's judgment. Exclusion Criteria: 1. Evidence of metastatic disease as determined by standard staging scans. a. Staging scans should be performed per urologic standard of care for patients undergoing radical prostatectomy [per American Urological Association (AUA)/National Comprehensive Cancer Network (NCCN) guidelines]. 2. Not a candidate for radical prostatectomy as determined by treating urologic oncology surgeon. 3. Any prior systemic therapy for PC, including antiandrogens, androgen deprivation therapy [gonadotropin-releasing hormone (GnRH) agonist or antagonist], chemotherapy, targeted therapy, immunotherapy, OR radiopharmaceuticals. a. Subjects who are on finasteride or dutasteride must discontinue therapy and undergo a washout period of 6 weeks to become eligible for the study. Screening procedures should begin following the washout period. 4. Prior radiotherapy for PC. 5. Any history of prior malignancy, except: 1. Non-melanoma skin cancer treated with curative intent 2. Carcinoma-in-situ (CIS) treated with curative intent, without evidence of recurrence or disease progression for 3 years 3. Appropriately treated Stage I uterine cancer 4. All other cancer: treated with curative intent and without evidence of disease on standard of care follow-up for 5 years 6. Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjogren's syndrome, Guillain-Barre syndrome, or multiple sclerosis, with the following exceptions: 1. Subjects with a history of autoimmune-related hypothyroidism who are on thyroid-replacement therapy, with a stable dose > 3 months, are eligible for the study 2. Subjects with controlled type 1 diabetes mellitus who are on an insulin regimen, with a Glycated hemoglobin (hemoglobin A1C) < 7.0 are eligible for the study. All subjects with controlled type 2 diabetes mellitus are eligible for the study 3. Subjects with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded from the study) are eligible for the study provided all of the following conditions are met:
• Rash covers < 10% of body surface area
• Disease is well controlled at baseline and requires only low-potency topical steroids
• No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months 7. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or any evidence of active, non-infectious pneumonitis requiring corticosteroids. 8. History of prior positive human immunodeficiency virus (HIV) test. 9. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (chronic or acute). 1. Subjects with a past or resolved HBV infection are eligible for this study. 2. HCV positivity is defined as having a positive HCV antibody test followed by a positive HCV ribonucleic acid (RNA) test at screening; the HCV RNA test will only be performed for subjects who have a positive HCV antibody test. 10. Significant cardiovascular disease, such as New York Heart Association class III or greater cardiac disease, myocardial infarction, or cerebrovascular accident within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina. 11. Active chronic obstructive pulmonary disease (COPD) requiring use of home oxygen (O2) or systemic steroid therapy > 10 mg prednisone (or equivalent) daily. 12. Asthma requiring systemic corticosteroids > 10 mg prednisone (or equivalent) daily. Inhaled corticosteroids for the treatment of asthma are permitted. 13. Major surgical procedure (including joint surgery) other than for diagnosis within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the course of the study. a. Placement of central venous access catheter (e.g., port or similar) is not considered a major surgical procedure and is therefore permitted. 14. Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia. 15. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications. 16. Prior allogeneic stem cell or solid organ transplantation. 17. Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during the course of the study or within 5 months after the last dose of atezolizumab. Note: Because IL-6 inhibition may interfere with the normal immune response to new antigen, patients should be brought up to date on all recommended vaccinations, except for live vaccines, prior to initiation of therapy with tocilizumab to maximize vaccine response. 18. Treatment with investigational therapy within 28 days prior to initiation of study treatment. 19. Prior treatment with adenosine-axis inhibitors, cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies, including anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), ant-PD-1, and anti-PD-L1 therapeutic antibodies. 20. Treatment with systemic immunostimulatory agents [including, but not limited to, interferon and interleukin 2 (IL-2)] within 4 weeks or five half-lives of the drug (whichever is longer) prior to initiation of study treatment. 21. Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor (TNF)- agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the course of the study, with the following exceptions: 1. Patients who receive acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study 2. Patients who receive mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma (=< 10 mg prednisone or equivalent), or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency (=< 10 mg prednisone or equivalent) are eligible for the study. 22. History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins. 23. Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation. 24. Known allergy or hypersensitivity to any of the study drugs of their excipients. 25. Previous treatment with any cell-depleting therapies, including investigational agents or approved therapies, some examples include: CAMPATH, anti-cluster of differentiation 4 (CD4), anti-cluster of differentiation 5 (CD5), anti-cluster of differentiation 3 (CD3), anti-Cluster of Differentiation 19 (CD19) and anti-Cluster of Differentiation 20 (CD20) within 5 years prior to first dose of study treatment. 26. Treatment with intravenous gamma globulin, plasmapheresis or Prosorba column within 6 months of baseline. 27. Previous treatment with tocilizumab (an exception to this criterion may be granted for single dose exposure upon application to the Sponsor-Investigator on a case-by-case basis). 28. Any previous treatment with alkylating agents such as chlorambucil, or with total lymphoid irradiation within 5 years prior to first dose of study treatment. 29. History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies. 30. Evidence of serious uncontrolled concomitant, nervous system, pulmonary, renal, hepatic, endocrine (include uncontrolled diabetes mellitus) or gastrointestinal disease (including complicated diverticulitis, ulcerative colitis, or Crohn's disease). 31. Any history of recent serious bacterial, viral, fungal, or other opportunistic infections. 32. Primary or secondary immunodeficiency (history of or currently active) unless related to primary disease under investigation. 33. Any medical or psychological condition that in the opinion of the principal investigator would interfere with safe completion of the trial. 34. Pregnant women or nursing (breast feeding) mothers. 35. Neuropathies or other conditions that might interfere with pain evaluation unless related to primary disease under investigation. 36. Patients with lack of peripheral venous access Additional Exclusion Criteria for Cohort B (atezolizumab + etrumadenant): 37. Treatment with known P-glycoprotein (P-gp) substrates with a narrow therapeutic window, administered orally (e.g., digoxin) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment. 38. Treatment with known strong CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, phenobarbital, and St. John's Wort) and strong CYP3A4 inhibitors (eg,clarithromycin, grapefruit juice, itraconazole, ketoconazole, posaconazole, telithromycin,and voriconazole) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment. 39. Treatment with known breast cancer resistance protein (BCRP) substrates with a narrow therapeutic window, administered orally (e.g., prazosin, rosuvastatin) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment. Additional Exclusion Criteria for Cohort C (atezolizumab + tocilizumab): 40. Known active infection or history of recurrent bacterial, viral, fungal, mycobacterial or other infections, including, but not limited to, TB (i.e., has signs and symptoms of TB) and atypical mycobacterial disease, hepatitis B and C, and herpes zoster, but excluding fungal infections of nail beds.

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Condition: Castration Levels of Testosterone, Metastatic Prostatic Adenocarcinoma, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03678025

Sponsor: SWOG Cancer Research Network

Phase: Phase 3

Eligibility:

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

Inclusion Criteria:

• STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: All patients must have a histologically or cytologically proven diagnosis of adenocarcinoma of the prostate. Patients with pure small cell carcinoma* (SCC), sarcomatoid, or squamous cell carcinoma are not eligible. (*morphology must be consistent with SCC; synaptophysin or chromogranin positive by immunohistochemical staining is insufficient to diagnose SCC).
• STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: Patients must have an intact prostate. No prior local therapy for prostate adenocarcinoma is allowed (e.g., brachytherapy, high-intensity focused ultrasound [HIFU], cryotherapy, laser ablative therapies). Any prior therapy for benign conditions, such as obstruction, are acceptable (e.g., transurethral resection of the prostate, greenlight laser ablation, microwave ablation).
• STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: Patients must have evidence of metastatic disease on technetium bone scan and computed tomography (CT) or magnetic resonance imaging (MRI) within 42 days prior to starting standard systemic therapy. Metastatic disease that is detected by positron emission tomography (PET) scan only (sodium fluoride [NaF], prostate-specific membrane antigen [PSMA], anti-1-amino-3-18F-fluorocyclobutane-1-carboxylic acid [FACBC], carbon [C]11) but not conventional imaging (technetium [Tc]99 bone scan, CT or MRI) or solitary metastases by conventional imaging, must be confirmed histologically or cytologically.
• STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: Patients with known brain metastases are not eligible. Brain imaging studies are not required for eligibility if the patient has no neurologic signs or symptoms suggestive of brain metastasis. If brain imaging studies are performed, they must be negative for disease.
• STEP 1 REGISTRATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients must have received no more than 28 weeks of standard systemic therapy (SST). SST is defined as current National Comprehensive Cancer Network (NCCN) guidelines for metastatic prostate cancer.
• STEP 1 REGISTRATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients must not have progressed while on SST.
• STEP 1 REGISTRATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients with oligometastatic prostate cancer may receive metastasis directed therapy to up to four sites of disease prior to randomization.
• STEP 1 REGISTRATION: CLINICAL/LABORATORY CRITERIA: Patients must have a complete physical examination and medical history within 28 days prior to registration.
• STEP 1 REGISTRATION: CLINICAL/LABORATORY CRITERIA: Patients must have a PSA documented prior to initiation of SST and within 28 days prior to registration. Any additional PSAs measured while receiving SST should be recorded.
• STEP 1 REGISTRATION: CLINICAL/LABORATORY CRITERIA: Patients must have a testosterone lab documented within 28 days prior to randomization. Any additional testosterone labs measured while receiving SST should be recorded as well as pretreatment initiation if available.
• STEP 1 REGISTRATION: CLINICAL/LABORATORY CRITERIA: No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, adequately treated stage 0, I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years.
• STEP 1 REGISTRATION: SPECIMEN SUBMISSION CRITERIA: Patients must be offered the opportunity to participate in translational medicine studies and specimen banking for future studies.
• STEP 1 REGISTRATION: QUALITY OF LIFE CRITERIA: Patients who can complete Patient-Reported Outcome instruments in English, Spanish or French, must participate in the quality of life studies.
• STEP 1 REGISTRATION: REGULATORY CRITERIA: Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
• STEP 2 RANDOMIZATION: DISEASE-RELATED CRITERIA: As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.
• STEP 2 RANDOMIZATION: DISEASE-RELATED CRITERIA: Patients must have no evidence of disease progression during the 28 weeks of SST by PSA measure, bone scan and CT or MRI or symptomatic deterioration (as defined by physician discretion) within 28 days prior to randomization.
• STEP 2 RANDOMIZATION: DISEASE-RELATED CRITERIA: Patients must have consultation with a urologist and have surgically resectable disease regardless of definitive treatment intent or randomization.
• STEP 2 RANDOMIZATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients must have received between 22 and 28 weeks of SST as measured from the date of first hormonal therapy or surgical castration. SST is defined by current NCCN guidelines for metastatic prostate cancer.
• STEP 2 RANDOMIZATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients must not be planning to receive docetaxel after randomization.
• STEP 2 RANDOMIZATION: PRIOR/CONCURRENT THERAPY CRITERIA: Any toxicities from SST must have resolved to =< grade 1 (Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) prior to randomization.
• STEP 2 RANDOMIZATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients may have received elective metastasis directed therapy to oligometastatic sites (=< 4 sites). All treatment must be completed prior to randomization.
• STEP 2 RANDOMIZATION: CLINICAL/LABORATORY CRITERIA: Patients must have a PSA performed within 28 days prior to randomization.
• STEP 2 RANDOMIZATION: CLINICAL/LABORATORY CRITERIA: Patients must have a testosterone < 50 ng/dL within 28 days prior to randomization.
• STEP 2 RANDOMIZATION: CLINICAL/LABORATORY CRITERIA: Patients must have a Zubrod performance status of 0 ? 1 within 28 days prior to randomization.

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Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03482089

Sponsor: Tongji Hospital

Eligibility:

• Age: minimum 18 Years maximum 75 Years
• Gender: Male

Inclusion Criteria:

1. Age ≤75, at the time of randomization
2. Newly diagnosed primary prostatic adenocarcinoma confirmed by pathological examination of biopsy；diagnosed within 6 months prior to randomization
3. Untreated for surgery, radiotherapy, or androgen deprivation therapy
4. Eastern Cooperative Oncology Group (ECOG) performance status 0- 2; American Standards Association (ASA) classification I-III
5. A life expectation of at least 10 years
6. Tumor stage (T, M, N): Clinical T4N0M0 with bladder invasion (confirmed by MRI)
7. Eligible for either treatment of cystoprostatectomy or radiotherapy
8. Signed informed consent should be obtained from both the patient or one authorized legal relative.

Exclusion Criteria:

1. Patients with a history of other cancer diagnoses except non-melanoma skin cancer
2. Patients with pelvic surgery
3. Patients with severe systemic diseases
4. severe kidney function -glomerular filtration rate (GFR) < 30 ml/min or elevated liver transaminases above > 10 upper limit of normal (ULN)
5. Patients who are not able comply with scheduled follow-up visits and examinations with the consideration of patients' physical or mental condition

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Condition: Prostate Cancer Metastatic

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03655886

Sponsor: University Hospital, Ghent

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

• Male ≥18y
• Histologically proven PC
• Newly diagnosed metastatic PC as assessed by standard imaging (CT and bone scintigraphy)
• ECOG 0-1 (2 if related to local PC symptoms)
• Eligible for local treatment
• Written informed consent and able and willing to comply with protocol requirements

Exclusion Criteria:

• Previous systemic treatment for PC except ADT started within 3 months before randomization
• Previous radiotherapy to the pelvis interfering with prostate irradiation
• Previous surgery in the pelvis interfering with radical prostatectomy
• Symptoms related to metastatic lesions, persisting for at least 2 weeks after initiation of ADT
• Metastatic brain disease, leptomeningeal disease or imminent spinal cord compression
• Previous or current malignant disease which is likely to interfere with LoMP II treatment or assessment
• Psychological disorder intervening with understanding the information or the informed consent

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Condition: Prostate Cancer, Cardiovascular Disease

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03127631

Sponsor: McMaster University

Eligibility:

• Age: minimum 45 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• 1. A man with a diagnosis of prostate cancer that is either:
• new (i.e. the diagnosis was made within 1 year of the enrolment visit) or
• treated with Androgen Deprivation Therapy for the first time within 6 months prior to the enrolment visit, or
• to be treated with Androgen Deprivation Therapy for the first time within 1 month after the enrolment visit

Exclusion Criteria:

1. Patients will be excluded if they fulfill any of the following:
2. are unwilling to provide consent or
3. are <45 years of age, or
4. prostate cancer was found incidentally following cystectomy for bladder cancer
5. Patients will be eligible for RADICAL PC1, but will not be eligible for RADICAL PC2 if they:
6. see a cardiologist every year, or
7. both take a statin and have systolic blood pressure ≤130mmHg

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Condition: Prostate Cancer

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT01961713

Sponsor: Massachusetts General Hospital

Phase:

Eligibility:

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

Inclusion Criteria:

• Male
• 18 years of age or older
• Pathologically confirmed diagnosis of prostate adenocarcinoma
• Non-metastatic prostate cancer
• Planned radical prostatectomy at Massachusetts General Hospital

Exclusion Criteria:

• Patients must not have received prior radiation therapy, hormone therapy, or other medical therapy for prostate cancer prior to prostatectomy. Post-prostatectomy therapy at the discretion of the patient's treating physician(s) is allowed.
• Patients must not have metastatic prostate cancer
• No prior or current diagnosis of epithelial malignancy, except for skin cancer (squamous cell carcinoma or basal cell carcinoma)

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Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02016248

Sponsor: MemorialCare Health System

Eligibility:

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

Inclusion Criteria:

1. Histologically proven prostate adenocarcinoma
2. Biopsy within 12 months of date of registration
3. Clinical Stage I-IV, MX-M0 (AJCC 6th Edition) M-stage determined by physical exam, CT, MRI, or Bone Scan. Bone scan not required for Monotherapy Risk Group patients unless clinical findings suggest possible osseous metastases. Bone Scan and contrast CT of the abdomen should be done patients in the Boost Risk Group patients.
4. Prostate volume: ≤ 100 cc (recommended not required) Determined using: volume = π/6 x length x height x width Measurement from CT or ultrasound ≤90 days prior to registration.
5. ECOG performance status 0-1
6. No prior prostatectomy or cryotherapy of the prostate
7. No prior radiotherapy to the prostate or lower pelvis
8. No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion.
9. Completion of patient questionnaires
10. Consent signed

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Condition: Prostate Cancer

Study Type: Observational [Patient Registry]

Clinical Trials Identifier NCT 8-digits: NCT03151629

Sponsor: Prostate Cancer Clinical Trials Consortium

Phase:

Eligibility:

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

Criteria: • Willing and able to provide written informed consent and privacy authorization for the release of personal health information. NOTE: Privacy authorization may be either included in the informed consent or obtained separately. - Males 21 years of age and above - Histological or cytological confirmed prostate adenocarcinoma from TRUS biopsy, radical prostatectomy or TURP Or Documented histopathology or cytopathology of prostate adenocarcinoma from a biopsy of a metastatic site Or Metastatic disease typical of prostate cancer (i.e., involving bone or pelvic lymph nodes or para-aortic lymph nodes) AND a serum concentration of PSA >20ng/mL at the time of initial prostate cancer diagnosis - No previous diagnosis of a second, non-prostate malignancy that requires additional systemic therapy except cancer in situ of bladder and basal cell cancer of skin

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Condition: Locally Recurrent Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03073278

Sponsor: Royal North Shore Hospital

Eligibility:

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

Inclusion Criteria:

• Men > 4yrs from external beam radiotherapy (EBRT) meeting the Phoenix definition of biochemical failure or men > 5yrs from EBRT if neo-adjuvant and/or adjuvant androgen deprivation therapy (ADT) also used
• Recurrence localised to less than 1 lobe of prostate on both PMSA and multi-parametric MRI (less than equal to cT2a)
• Recurrence must be biopsy proven, with positive biopsies limited to the PET and MRI suspicious region.
• Life expectancy at least 10yrs from time of SBRT
• PSA < 10

Exclusion Criteria:

• Recurrence in immediate proximity to rectum (unless able to have hydrogel)
• Grade 3 or more toxicity from previous EBRT
• Contra-indicated for fiducial insertion
• GS 8,9 or 10 disease previously (relative
• consider if decent disease free interval)

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Condition: Prostatic Neoplasms, Prostate Cancer

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT02899312

Sponsor: British Columbia Cancer Agency

Phase:

Eligibility:

• Age: minimum 19 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• Known PC with a biochemical recurrence (BR) after initial curative therapy with radical prostatectomy, with a documented history of failure of PSA to fall to undetectable levels (PSA persistence) or undetectable PSA after radical prostatectomy with a subsequent detectable PSA that increased on 2 or more determinations (PSA recurrence). The patient may have received treatment following documentation of PSA persistence or PSA recurrence. The most recent PSA measurement must be greater than 0.4 ng/mL.
• Participants with findings on other examinations (such as plain x-ray, CT, MRI or bone scintigraphy and others) that are suspicious for metastatic disease but not conclusively diagnostic of metastatic disease.
• Known PC with BR after initial curative therapy with radiation therapy (including brachytherapy), with a PSA level >2 ng/mL above the nadir after radiation therapy.
• Castration resistant PC with a minimum PSA of 2.0 ng/mL with 2 consecutive rises above the nadir and castrate levels of testosterone (<1.7 nmol/L). Treatment does not need to be discontinued before the 18F-DCFPyL scan.
• Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less.

Exclusion Criteria:

• Medically unstable (eg. 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)

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Condition: Renal Tumor Histology, Cutaneous Leiomyoma, Kidney Cancer

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT00050752

Sponsor: National Cancer Institute (NCI)

Phase:

Eligibility:

• Age: minimum 2 Years maximum N/A
• Gender: All

Inclusion Criteria:

• Patients suspected or known to have phenotype or genotype suggestive of Hereditary Leiomyomatosis and Renal Cell Cancer Syndrome (HLRCC), such as:
• Cutaneous leiomyoma and kidney cancer
• Cutaneous leiomyoma and uterine leiomyoma
• Multiple cutaneous leiomyoma
• Kidney cancer and uterine leiomyomata
• Renal tumor histology consistent with HRLRCC including, but not limited to: Collecting Duct and/or Papillary, Type II
• All patients and parents/guardians, for children younger than 18 years of age, must sign an informed consent document indicating their understanding of the investigational nature and the risks of this study before any protocol related studies are performed. Patients under the age of 18 but who are age 13 or older will be asked to sign an assent document prior to participation.
• Participants must be >= 2 years of age.
• A relative (related by blood) of a patient with a confirmed or suspected diagnosis of HLRCC.

Exclusion Criteria:

1. None

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Condition: Malignant Neoplasms, Hereditary Neoplastic Syndromes, Kidney Cancer, Renal Cancer, Bladder Cancer

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT00026884

Sponsor: National Cancer Institute (NCI)

Phase:

Eligibility:

• Age: minimum 2 Years maximum N/A
• Gender: All

Inclusion Criteria:

• Adult and minor patients with biopsy-proven malignant disease
• Adult and minor patients suspected of having a malignant disease
• Patients who have or are suspected of having an inherited genitourinary malignant disorder
• Participants must be >= 2 years of age
• Family members (related by blood) of patients who have or are suspected of having a malignant disease or an inherited genitourinary malignant disorder.
• All patients and guardians, for children younger than 18 years of age, must sign an informed consent document indicating their understanding of the investigational nature and the risks of this study before any protocol related studies are performed. Patients under the age of 18 but who are age 13 or older will be asked to sign an assent document prior to participation.

Exclusion Criteria:

• Subjects whose co-morbidities preclude surgical intervention.

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Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT00969111

Sponsor: Proton Collaborative Group

Eligibility:

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

Inclusion Criteria:

• Prostate cancer treated primarily with open, laparoscopic or robotically assisted prostatectomy.
• Maximum PSA value of 20 ng/ml.

Exclusion Criteria:

• Evidence of distant metastasis (M1).
• Prior systemic chemotherapy for any reason.
• Previous irradiation to the pelvis that would compromise the ability to deliver the prescribed study treatment.
• Active inflammatory bowel disease (Crohn's disease, diverticulitis or ulcerative colitis) affecting the rectum. (Non-active diverticulitis and Crohn's disease not affecting the rectum are allowed).
• History of hip replacement.
• Prior or concurrent cancer, other than non-melanomatous skin cancer, unless disease free for at least 5 years.
• Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its use during radiation.

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Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01407263

Sponsor: Memorial Sloan Kettering Cancer Center

Phase: Phase 3

Eligibility:

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

Inclusion Criteria:

• Patients do not have to be eligible for both modifications to be included in the study. Lymphadenectomy vs no lymphadenectomy:
• Patients 21 years or older scheduled for radical prostatectomy for treatment of prostate cancer with one of the consenting surgeons at MSKCC Hemostatic agent vs. no hemostatic agent
• Patients 21 years or older scheduled for minimally invasive radical prostatectomy for the treatment of prostate cancer with one of the consenting surgeons at MSKC Exclusion Criteria: Lymphadenectomy vs no lymphadenectomy
• Presence of positive/suspicious pelvic nodes on MRI, CT or PSMA scan (positive/suspicious defined as a pelvic node >15mm in short axis on CT or MRI, a PSMA avid node, or a node with abnormal morphology such as roundness or irregularity or loss of fatty hilum)
• Any prior pelvic radiation therapy used to treat prostate cancer Hemostatic agent vs. no hemostatic agent
• No additional

Exclusion Criteria:

• Lymphadenectomy vs no lymphadenectomy
• Presence of positive/suspicious pelvic nodes on MRI, CT or PSMA scan (positive/suspicious defined as a pelvic node >15mm in short axis on CT or MRI, a PSMA avid node, or a node with abnormal morphology such as roundness or irregularity or loss of fatty hilum)
• Any prior pelvic radiation therapy used to treat prostate cancer Hemostatic agent vs. no hemostatic agent
• No additional exclusion criteria

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Condition: Prostate Cancer, Breast Cancer, Lung Cancer, Ovarian Cancer, Lymphoma

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT01441089

Sponsor: National Cancer Institute (NCI)

Phase:

Eligibility:

• Age: minimum 3 Years maximum N/A
• Gender: All

Inclusion Criteria:

1. Patients with cancer, other tumors, or tumor predisposition syndromes currently enrolled in NIH intramural research program therapeutic trials. Ability of participant or Legally Authorized Representative (LAR) to understand and be willing to sign the informed consent document. Age >= 3 years old

Exclusion Criteria:

1. N/A

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Condition: Prostate Cancer, Breast Cancer, Colon Cancer, Lung Cancer, Liver Cancer

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT00034216

Sponsor: National Cancer Institute (NCI)

Phase:

Eligibility:

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

Inclusion Criteria:

1. Patients with a known or suspected malignancy and healthy volunteers 18 years of age and older are eligible. Performance status of ECOG 0, 1, 2, or 3 for admission to this protocol. Ability to understand and the willingness to sign a written informed consent document. INCLUSION FOR APHERESIS: Note: Effective with Amendment CC, participants will no longer be asked to undergo apheresis. This content is being retained for historical reference. Hemoglobin greater than or equal to 10 mg/dL and platelet count > 75,000/mm(3) Weight greater than 25 kg HIV negative Prothrombin Time within normal limits Partial Thromboplastin Time within normal limits Medically indicated central line in place or adequate peripheral venous access

Exclusion Criteria:

1. None.

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Condition: Prostate Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02739659

Sponsor: Shanghai Proton and Heavy Ion Center

Eligibility:

• Age: minimum 20 Years maximum 85 Years
• Gender: Male

Inclusion Criteria:

• Pathologically confirmed adenocarcinoma of the prostate
• No lymph node and distant metastasis
• Age ≥ 20 and < 85 years of age
• Karnofsky Performance Score ≥70
• No previous pelvic radiation therapy (RT)
• No previous prostatectomy
• No previous invasive cancer (within 5 years before the prostate cancer diagnosis)except for skin non-melanoma cancer
• Ability to understand character and individual consequences of the clinical trial
• Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial

Exclusion Criteria:

• No pathologically confirmed adenocarcinoma of the prostate
• Pelvic lymph node metastasis (N1)
• Distant metastasis (M1)
• Urinary obstructive symptoms (IPSS > 20)
• Previous pelvic radiotherapy
• Previous prostatectomy
• Severe systemic disorders
• Concomitant disorders including: chronic urinary or intestinal inflammatory conditions (for example, ulcerous recto-colitis, Crohn disease), anti-coagulant treatment (warfarin, heparin)
• Previous malignancy except for skin non-melanoma cancer or 3-year disease free interval from previous malignancy like non muscle invasive bladder cancer
• Non conformity of the radiotherapy dose distribution when compared to the dose constraints
• Psychiatric disorders or any other condition that can make unreliable the informed consent

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