Prostate Cancer

Condition: Prostate Cancer, Obesity

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT04167722

Sponsor: Imperial College London

Phase:

Eligibility:

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

Inclusion Criteria:

• All men undergoing radical prostatectomy at Charing Cross Hospital

Exclusion Criteria:

• Patients unable to consent

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Condition: Prostate Cancer

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT03408964

Sponsor: Andrea Alimonti

Phase:

Eligibility:

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

Inclusion Criteria:

• General inclusion criteria (for entering all groups)
• Age ≥ 18 years
• Histological diagnosis of prostate adenocarcinoma at different stages of disease (see Section 6.2) for which a treatment is indicated
• Written Informed Consent Inclusion criterion only for entering Group 0 • Patients with a known diagnosis of CSPC or CRPC Inclusion criterion only for entering Group 1a • Patients that underwent biopsies for a suspect of PC, but resulted negative for cancer Exclusion Criteria: General exclusion criteria (for entering all groups)
• Active infection requiring treatment
• Decrease of general condition
• Concomitant severe comorbities
• Difficult socioeconomic conditions making regular follow up unfeasible.
• Need of concomitant steroids at study entry and during the study
• Diagnosis of second tumor in the previous 5 years Exclusion criterion only for entering Group 0 • No antibiotic treatments in the previous 2 months before enrollment Exclusion criteria only for entering Group 1
• Previous radical surgery and / or radical radiotherapy
• Previous hormonal treatments

Exclusion Criteria:

• General exclusion criteria (for entering all groups)
• Active infection requiring treatment
• Decrease of general condition
• Concomitant severe comorbities
• Difficult socioeconomic conditions making regular follow up unfeasible.
• Need of concomitant steroids at study entry and during the study
• Diagnosis of second tumor in the previous 5 years Exclusion criterion only for entering Group 0 • No antibiotic treatments in the previous 2 months before enrollment Exclusion criteria only for entering Group 1
• Previous radical surgery and / or radical radiotherapy
• Previous hormonal treatments Exclusion criteria only for entering Group 2
• No antibiotic treatments in the previous 2 months before enrollment (only in patients enrolling also for metagenomics and metabolomics)
• Previous hormonal treatments for advanced disease Exclusion criterion only for entering Group 3 • No antibiotic treatments in the previous 2 months before enrollment (only in patients enrolling also for metagenomics and metabolomics analyses)

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Condition: Neoplasms Prostate, Cancer of the Prostate

Study Type: Observational [Patient Registry]

Clinical Trials Identifier NCT 8-digits: NCT02381990

Sponsor: Urological Research Network, LLC

Phase:

Eligibility:

• Age: minimum 55 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• Men between 55 and 65 years of age with a clinical diagnosis of prostate cancer with Low or Intermediate risk prostate cancer, and <50% positive core rate by prostate lobe
• Men older than 65 years of age with clinical diagnosis of prostate cancer <50% positive core rate by prostate lobe
• Absence of extra-capsular extension
• Absence of seminal vesicle invasion
• Absence of regional or distant metastatic disease
• Multiparametric MRI of the prostate performed either before the biopsy or >10 weeks after prostate biopsy
• Treated with Cryotherapy of the prostate
• Treatment based on co-registration between MP-MRI and Prostate Ultrasound

Exclusion Criteria:

• Prior treatment of prostate cancer in the form of surgery.
• Performance status greater than 0 based on ECOG criteria
• Mental status impairment

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Condition: Prostate Cancer, Radiotherapy Side Effects, Volatile Organic Compounds, DNA Damage

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT04081428

Sponsor: NHS Lothian

Phase:

Eligibility:

• Age: minimum 18 Years maximum 80 Years
• Gender: Male

Inclusion Criteria:

• Low risk prostate cancer T1-2, PSA<10ng/ml, Gleason score (GS) 3+3=6
• Intermediate risk prostate cancer T1-T2, PSA 10-20ng/ml,GS ≤7(3+4=7 only)
• World Health Organisation (WHO) performance status 0-2
• Prostate volume ≤90cc
• International Prostate Symptom Score (IPSS) ≤20
• Peak urinary flow rate (Q-max) >10cc/sec
• Urinary residual <250mls total
• No prior Trans Urethral Resection of the Prostate (TURP)
• No previous pelvic radiotherapy
• Able to give informed consent
• Aged between 18-85 years of age

Exclusion Criteria:

• Inflammatory bowel disease
• Previous androgen deprivation therapy
• History of urinary retention

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Condition: Prostate Cancer, PSA, Infection

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04081636

Sponsor: Albany Medical College

Eligibility:

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

Inclusion Criteria:

• All patients who are scheduled to undergo prostate biopsy for suspected prostate cancer as part of their regular medical care
• Either with or without an MRI

Exclusion Criteria:

• Patients with no access to rectum (due to previous rectal surgery)
• Any abnormalities of the perineal skin (e.g. infection)
• Patients whose procedure requires sedation or general anesthesia

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Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04083937

Sponsor: University Hospital Heidelberg

Eligibility:

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

Inclusion Criteria:

• histology-proven prostate cancer with Gleason Score and PSA-value;
• indication for prostate bed irradiation (adjuvant/ salvage) after prostatectomy;
• Karnofsky-Index ≥ 70%
• age ≥ 18 years

Exclusion Criteria:

• androgen deprivation therapy
• lymphatic spread
• macroscopic tumor/ R2
• stage IV (M1)
• previous irradiation

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Condition: Prostate Adenocarcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04175431

Sponsor: University of Washington

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

• Patient must have histologically or cytologically documented evidence of prostate adenocarcinoma
• Patient must previously have undergone radical prostatectomy
• Patient must previously have undergone either adjuvant or salvage radiation therapy to the prostatic fossa +/- whole pelvis
• Patient must have a prostate specific antigen (PSA) >= 0.2 and < 10 ng/mL. If there is only one PSA value that has risen to >= 0.2 with this biochemical recurrence, a second PSA value must be confirmed to be within >= 0.2 and < 10 ng/mL at least 2 weeks from the first value and within 28 days of enrollment
• PSA doubling time must be calculated utilizing either all PSA measurements > 0.1 ng/mL from most recent biochemically-recurred (BCR) or the most recent 3 PSA measurements > 0.1 ng/mL (if the latter, all 3 PSA measurements must be > 2 weeks apart to be used in the calculation). PSA doubling time must be > 3 months and < 18 months. The Memorial Sloan Kettering PSA doubling time calculator should be used
• Patient must have no previous evidence of radiographically detectable metastatic prostate cancer by conventional CT and bone scan imaging
• Patient must have total testosterone level > 120 ng/dL demonstrated within 42 days of enrollment
• Patient must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Absolute neutrophil count (ANC) >= 1.0 X 10^9/L
• Platelet count >= 100 X 10^9/L
• Hemoglobin >= 9 g/dL
• Potassium >= 3.5
• Serum bilirubin =< 1.5 X upper limit of normal (ULN) or =< 3 X ULN for patients with documented Gilbert's syndrome
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 X ULN
• Creatinine clearance (Cr Cl) >= 30 mL/min as estimated by the Cockcroft-Gault criteria or as determined by 24 hour Cr Cl measurement
• Patient must be >= 18 years of age on day of signing informed consent
• Patient must be able to understand and authorize informed consent

Exclusion Criteria:

• Chronic active hepatitis B or C
• History of a second, non-prostate malignancy that required systemic therapy in the last 2 years except cancer in situ of bladder and non-melanomatous cancers of the skin
• Patient with a serious underlying medical condition that would otherwise impair the patient's ability to undergo fluciclovine or PSMA PET/CT imaging or receive subsequent treatment
• Any condition that would alter the patient's mental status, prohibiting understanding and/or authorization of informed consent
• Expected lifespan of less than 12 weeks
• Inability to lay still for imaging
• Weight > 300 lbs. (due to equipment specifications)
• Any other underlying medical condition that, in the opinion of the investigator, would impair the ability of the patient to receive or tolerate the planned treatment and/or follow up

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Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01567800

Sponsor: University Health Network, Toronto

Eligibility:

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

Inclusion Criteria:

• Age => 18 years
• Histologic diagnosis of adenocarcinoma of the prostate
• Bulky intermediate risk, high risk or metastatic prostate cancer Bulky intermediate risk: cT1-2 with >50% of diagnostic biopsy cores containing cancer and Gleason 6 or 7 and prostate specific antigen (PSA) >10 and ≤20 OR High risk: cT1-2 with Gleason score ≥8; or cT1-2 with PSA >20; or cT3 OR N+ and/or M1 disease OR Newly diagnosed hormone-refractory prostate cancer
• Intention to treat using radiotherapy +/- concurrent and adjuvant hormonal therapy
• Intention to treat with radiotherapy, hormonal therapy, other systemic treatment for prostate cancer, or a combination of these according to the Princess Margaret Genitourinary Site policies.
• Previous or concurrent anti-cancer therapy for the PET FAZA target lesion allowed
• Ability to provide written informed consent to participate in the study

Exclusion Criteria:

• Inability to lie supine for more than 60 minutes
• Patients taking the drug disulfiram (Antabuse)
• Contraindications for MRI: only applicable in cases where the PET FAZA target lesion is identified as the prostate gland. Patients with target lesions at other anatomic sites will not undergo MR imaging.
• Patients weighing > 136 kg

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Condition: Prostate Cancer, Prostate Neoplasm

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03232164

Sponsor: University of Wisconsin, Madison

Phase: Early Phase 1

Eligibility:

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

Inclusion Criteria:

• Prostate cancer pathologically proven by prostate biopsy (newly diagnosed for Sub-Study 1 and 4)
• Prostate biopsy histology grade ≥ Gleason 1, 6, 3+4, or 4+3; positive biopsy >2 cores
• Any PSA permitted
• Two consecutive rising PSA values (Sub-Study 3 only)
• Castrate-levels of testosterone
• total testosterone < 50 ng/dL (Sub-Study 3 only)
• Patients considered as candidates for and medically fit to undergo prostatectomy
• At least 7 days after most recent prostate biopsy
• Imaging evidence of suspected metastatic disease, including CT, bone scan, MRI, ultrasound or other PET modalities (Sub-Study 3 only)
• New diagnosis of prostate cancer undergoing additional biopsy evaluation (Sub--Study 4 only)
• Karnofsky performance status of at least 70 (Sub-Study 4 only)
• General health and anatomy suitable to undergo transrectal ultrasound-MRI fusion biopsy of the identified lesions and standard 12 core sextent biopsy (Sub-Study 4 only)

Exclusion Criteria:

• Prior pelvic external beam radiation therapy or brachytherapy
• Chemotherapy for prostate cancer
• Androgen deprivation therapy for prostate cancer
• Investigational therapy for prostate cancer (Sub-Study 3 Only)
• Unable to lie flat during or tolerate PET/CT
• Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.
• No prostatectomy scheduled more than 12 hours post imaging (Sub-Study 1 only)
• Serum creatinine > 2 time the upper limit of normal
• Total bilirubin > 3 times the upper limit of normal
• Liver Transaminases > 5 times the upper limit of normal

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Condition: Hormone Refractory Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02955082

Sponsor: Institute of Cancer Research, United Kingdom

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

1. All study participants will be assessed according to the part 1 and/ or part 2 inclusion criteria depending on which part of the study they enter initially. For Part 1 (genetic screening) of the study:
2. Age ≥ 18 years.
3. Recorded diagnosis of prostate cancer with or without histological confirmation. Patients who have not previously undergone a prostate (or metastatic) biopsy but are confirmed to have a raised PSA (>80ng/ml at any time), metastatic disease on imaging and have undergone treatment for mCRPC are eligible.
4. Castration-resistant disease defined as biochemical or radiological progression on/after treatment with orchidectomy or LHRH analogues as per PCWG3 criteria.
5. Confirmed metastatic disease on conventional imaging methods such as CT, bone scan or PET imaging.
6. Current or previous treatment includes at least one of the following:
7. Docetaxel (either in hormone sensitive or resistant setting; Patients who have completed treatment with or are currently undergoing Cabazitaxel chemotherapy are also eligible)
8. Androgen receptor-directed therapy (e.g., Enzalutamide, Abiraterone)
9. Adequate renal function measured by calculated GFR (Cockcroft-Gault) >30ml/min. If a participant had renal dysfunction that is expected to improve, they may be considered for part 1 of the study.
10. Adequate haematological function to allow study entry in line with local hospital practice or at the investigator's discretion.
11. WHO performance status 0-2 as assessed and documented by study doctor.
12. Life expectancy >12 weeks
13. Participants with stable, treated brain metastases will be eligible providing informed consent can be given and that other sites of measurable disease are present
14. The subject is capable of understanding and complying with the protocol requirements and has signed the BARCODE 2 informed consent form. In addition to the above, for Part 2 of the study:
15. Confirmed pathogenic germline mutation in a DNA repair gene. (Participants with a known germline mutation will need to provide a report from the external laboratory where genetic testing was carried out)
16. Previous treatment with docetaxel and androgen receptor-directed therapy (e.g., abiraterone or enzalutamide) with documented disease progression prior to entry to part 2 (rising PSA and/or radiographic progression). Patients previously treated with cabazitaxel and who have documented disease progression are also eligible.
17. Adequate haematological function: Haemoglobin (Hb) ≥8.0g/dL, neutrophil count ≥1.5x109/L and platelets ≥100x109/L.
18. Adequate liver function: Total bilirubin ≤1.5 x upper limit of normal (ULN) except for participants with known Gilbert's syndrome; AST and ALT ≤ 2.5x ULN in the presence of liver metastases.
19. Adequate renal function: creatinine clearance >30ml/min measured by a glomerular filtration rate (GFR) clearance test. If a measured GFR test is not available, then calculated GFR is acceptable (measured GFR must be carried out by cycle 2 of carboplatin).

Exclusion Criteria:

1. (for part 1 and 2):
2. Critical organ metastases (e.g. spinal metastases with risk of cord compression) as documented on most recent imaging report.
3. Participants with bleeding tumours.
4. Previous treatment with a platinum chemotherapy drug for prostate cancer.
5. Previous treatment with a PARP inhibitor
6. Participants with a history of severe allergic reaction to carboplatin or other platinum-containing compounds
7. Exposure to yellow fever vaccine in the previous 6 months.
8. Participants unfit for chemotherapy or those with ongoing neuropathy >grade 1 (sensory or motor) according to NCI CTCAE V4.
9. Known and documented hearing impairment
10. Other active malignancies or previous malignancies likely, in the PI's opinion, to impact on management of mCRPC.
11. Significant documented cardiovascular disease: severe/unstable angina, myocardial infarction less than 6 months prior to trial entry, arterial thrombotic events less than 6 months prior to trial entry, clinically significant cardiac failure requiring treatment (NYHA II-IV).
12. Cerebrovascular disease (CVA or TIA) in the preceding 2 years to entry to Part 2 of study.
13. Presence of symptomatic brain metastases.

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Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01794403

Sponsor: University of Miami

Eligibility:

• Age: minimum 35 Years maximum 85 Years
• Gender: Male

Inclusion Criteria:

• 1. Histologically proven prostate adenocarcinoma.
• Gleason score 2-7 (reviewed by reference lab at UM).
• Biopsy within one year of date of enrollment. 2. Clinical stage ≤ T2 based on DRE and/or ≤ T3a based on MRI (if done); N0-Nx; M0-Mx (AJCC 7th Edition)
• T-stage and N-stage determined by physical exam and available imaging studies (CT, and/or MRI of the pelvis; see section 4.5). For MRI, questionable extracapsular extension is permitted. To distinguish blood from tumor the ideal study would be to acquire T2, T1 noncontrast and T1 dynamic contrast enhanced sequence, although this is not required. A small amount of extracapsular extension is permitted, as long as it can be included in the clinical target volume (CTV) and the constraints are met.
• M-stage determined by physical exam, CT or MRI. Bone scan not required unless clinical findings suggest possible osseous metastases. 3. Prostate-Specific Antigen (PSA) < 20 ng/ml, obtained no greater than 3 months prior to enrollment. 4. Patients belonging in one of the following risk groups:
• Low:
• Clinical stage* T1-T2; Gleason ≤ 6, PSA ≤ 10 & <50% biopsy cores positive.
• Intermediate:
• Clinical stage T2b-T2c; Gleason ≤ 6, PSA ≤ 10 & <50% biopsy cores positive.
• Clinical stage T1-T2; Gleason ≤ 6, PSA ≤ 10 & ≥50% biopsy cores positive.
• Clinical stage T1-T2; Gleason = 7, PSA ≤ 10 & <50% biopsy cores positive or T1-T2; Gleason ≤ 6 & PSA >10 and < 20 & < 50% biopsy cores positive.
• MRI stage T3a with evidence of extraprostatic extension is allowed.
• Clinical stage is based on digital rectal exam (DRE). Seminal vesicle invasion on MRI is not eligible. T1a should be permitted if subsequent peripheral zone biopsies show tumor. 5. Prostate volume: ≤ 80 cc.
• Determined using: volume = π/6 x length x height x width.
• Measured from CT or MRI ≤90 days prior to enrollment. 6. Zubrod performance status 0-1. 7. No prior total prostatectomy or cryotherapy of the prostate.
• Prior suprapubic prostatectomy, transurethral resection and laser ablation are permitted. 8. No prior radiotherapy to the prostate or lower pelvis. 9. No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion. 10. No chemotherapy for a malignancy in the last 5 years. 11. No history of an invasive malignancy (other than this prostate cancer, or nonmetastatic basal or squamous skin cancers) in the last 5 years. 12. 4-6 months of androgen deprivation therapy (ADT) are allowed for intermediate risk patients. This must be declared prior to randomization. This may not have been started more than 2 months prior to randomization. 13. Patient must be able to have gold fiducial markers placed in the prostate (if on anticoagulants, must be cleared by a primary care physician or cardiologist), or if patient already has fiducial marker placed, they must be in accordance with the protocol specifications (Section 4.2.2). NOTE: If a method of intrafraction prostate tracking is available which does not require fiducial markers, this will be adequate for this trial (i.e. 4D transperitoneal ultrasound, onboard MRI guidance). 14. Ability to understand and the willingness to sign a written informed consent document. 15. Willingness to fill out quality of life/psychosocial forms. 16. Age >= 35 and =< 85 years. 17. IPSS (AUA) score ≤12

Exclusion Criteria:

1. Does not have a diagnosis of prostate adenocarcinoma.
2. Patient has clinical T3a or any evidence of T3b disease.
3. Patient has stage N1 or M1 disease.
4. Patients has a PSA of greater than 20 ng/ml, obtained no greater than 3 months prior to randomization.
5. Patient does not meet any of the risk groups outlined in section 3.1.
6. Prostate volume greater than 80 cc.
7. Zubrod performance status 2 or greater.
8. Prior total prostatectomy.
9. Prior radiation therapy to the prostate or lower pelvis.
10. Implanted hardware which limits treatment planning or delivery (determined by the investigator).
11. Chemotherapy within the past 5 years.
12. Diagnosis of an invasive malignancy within 5 years (other than current prostate cancer or non-metastatic basal or squamous skin cancers or non-metastatic curatively treated papillary thyroid carcinoma).
13. The use of more than 2 months of androgen deprivation therapy (ADT) prior to randomization, or plans for ADT to be continued for greater than 6 months.
14. Inability to have gold fiducial markers placed in the prostate, or fiducial markers already placed that are not in accordance with the protocol (Section 4.2.2). NOTE: If a method of intrafraction prostate tracking is available which does not require fiducial markers, this will be adequate for this trial (i.e. 4D transperitoneal ultrasound, onboard MRI guidance).
15. Unwilling or inability to give informed consent.
16. Not willing to fill out quality of life/psychosocial questionnaires.
17. IPSS score > to
18. Age < 35 and > 85 years.

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Condition: Recurrent Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03067051

Sponsor: SpectraCure AB

Phase: Phase 1/Phase 2

Eligibility:

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

Inclusion Criteria:

1. Males > 18 years who have gone through external or internal, high dose rate (brachy) radiation therapy for localized prostate cancer with histopathologically verified local recurrence.
2. Prostate volume less than 50 cm3 defined by transrectal ultrasound
3. Subject not eligible for surgery or curative radiotherapy
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
5. Expected survival ≥ 8 months
6. Sufficient bone marrow reserve as indicated by; granulocyte count ≥ 1500/mm3, platelet count ≥ 100,000/mm3
7. Adequate renal function as defined by creatinine ≤ 1.5 mg /dl
8. Adequate hepatic function, based on a total bilirubin ≤ 1.5 mg/dl, serum glutamate-oxaloacetate transaminase (SGOT) ≤ 3 times the upper limit of normal, and alanine transaminase (ALT) ≤ 3 times the upper limit of normal
9. Signed Informed Consent Phase 1 Exclusion Criteria:
10. Patients with locally advanced (AJCC 7th edition T3/T4) or metastatic disease
11. Patients who have been treated with seed implantation brachytherapy
12. Gleason score ≥ 8 at initial diagnosis
13. Less than 1 week since surgery (excluding minimal procedures, e.g. vascular access device insertion)
14. Concomitant infection
15. Subjects with other severe concurrent disease that in the judgement of the investigator would make the subject inappropriate for entry into this study
16. Mental incapacity or psychiatric illness that would interfere with the subject's ability to understand and give informed consent or to complete follow-up visits according to the judgement of the investigator
17. Contraindication for photosensitizer
18. Porphyria or other diseases exacerbated by light
19. Known hypersensitivity to verteporfin for injection (VFI) or to any of the excipients
20. Known allergies to porphyrins
21. Tumours known to be eroding into a major blood vessel in or adjacent to the illumination site
22. On-going therapy with a photosensitizing agent
23. Enrolment in another therapeutic clinical study within 3 months prior to randomization and throughout the study.
24. Subjects with a history of CTCAE v4 grade 3 or greater or persistent (>1 separate episode or symptoms lasting more than 3 months after initiation of medical intervention) grade 2 proctitis attributed to radiation. Phase 2 Inclusion Criteria:
25. Subjects > 18 years who have gone through external or internal, high dose-rate (brachy) radiation therapy for localized prostate cancer with histopathologically verified local recurrence.
26. Treatment target volume less than 50 cm
27. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
28. Expected survival ≥ 12 months.
29. Sufficient bone marrow reserve as indicated by; granulocyte count ≥ 1500/mm3, platelet count ≥ 100,000/mm
30. Adequate renal function as defined by creatinine ≤ 1.5 mg /dl.
31. Adequate hepatic function, based on a total bilirubin ≤ 1.5 mg/dl, serum glutamate- oxaloacetate transaminase (SGOT) ≤ 3 times the upper limit of normal, and alanine transaminase (ALT) ≤ 3 times the upper limit of normal.
32. Signed Informed Consent. Phase 2

Exclusion Criteria:

1. Patients with locally advanced (AJCC 7th edition T3/T4) or metastatic disease
2. Patients who have been treated with seed implantation brachytherapy
3. Gleason score ≥ 8 at initial diagnosis
4. Less than 1 week since surgery (excluding minimal procedures, e.g. vascular access device insertion)
5. Concomitant infection
6. Subjects with other severe concurrent disease that in the judgement of the investigator would make the subject inappropriate for entry into this study
7. Mental incapacity or psychiatric illness that would interfere with the subject's ability to understand and give informed consent or to complete follow-up visits according to the judgement of the investigator
8. Contraindication for photosensitizer
9. Porphyria or other diseases exacerbated by light
10. Known hypersensitivity to verteporfin for injection (VFI) or to any of the excipients
11. Known allergies to porphyrins
12. Tumours known to be eroding into a major blood vessel in or adjacent to the illumination site
13. On-going therapy with a photosensitizing agent
14. Enrolment in another therapeutic clinical study within 3 months prior to randomization and throughout the study.
15. Subjects with a history of CTCAE v4 grade 3 or greater or persistent (>1 separate episode or symptoms lasting more than 3 months after initiation of medical intervention) grade 2 proctitis attributed to radiation. Phase 2 Inclusion Criteria:
16. Subjects > 18 years who have gone through external or internal, high dose-rate (brachy) radiation therapy for localized prostate cancer with histopathologically verified local recurrence.
17. Treatment target volume less than 50 cm
18. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
19. Expected survival ≥ 12 months.
20. Sufficient bone marrow reserve as indicated by; granulocyte count ≥ 1500/mm3, platelet count ≥ 100,000/mm
21. Adequate renal function as defined by creatinine ≤ 1.5 mg /dl.
22. Adequate hepatic function, based on a total bilirubin ≤ 1.5 mg/dl, serum glutamate- oxaloacetate transaminase (SGOT) ≤ 3 times the upper limit of normal, and alanine transaminase (ALT) ≤ 3 times the upper limit of normal.
23. Signed Informed Consent. Phase 2 Exclusion Criteria:
24. Subjects with locally advanced (AJCC 7th edition T3/T4), regional pelvic lymph node metastasis, or metastatic disease defined by PSMA PET.
25. Subjects who have been treated with seed implantation brachytherapy.
26. Less than 1 week since surgery (excluding minimal procedures, e.g. vascular access device insertion).
27. Concomitant infection.
28. Subjects with other severe concurrent disease that in the judgement of the investigator would make the subject inappropriate for entry into this study.
29. Mental incapacity or psychiatric illness that would interfere with the subject's ability to understand and give informed consent or to complete follow-up visits according to the judgement of the investigator.
30. Contraindication for photosensitizer.
31. Porphyria or other diseases exacerbated by light.
32. Known hypersensitivity to verteporfin for injection (VFI) or to any of the excipients.
33. Known allergies to porphyrins.
34. Tumours known to be eroding into a major blood vessel in or adjacent to the illumination site.
35. On-going therapy with a photosensitizing agent.
36. Enrolment in another therapeutic clinical study within 3 months prior to randomization and throughout the study.
37. Subjects with a history of CTCAE v4 grade 3 or greater or persistent (>1 separate episode or symptoms lasting more than 3 months after initiation of medical intervention) grade 2 proctitis attributed to radiation.
38. Contraindication for MRI/Gadolinium contrast such as: implants, severe renal impairment (glomerular filtration rate [GFR] <30 mL/min/1.73m2, or previous contrast reactions.
39. On-going or planned hormone therapy.

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Condition: Metastatic Castration Resistant Prostate Cancer (mCRPC)

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03874884

Sponsor: Peter MacCallum Cancer Centre, Australia

Phase: Phase 1

Eligibility:

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

Inclusion Criteria:

• Patients must meet all of the following criteria for study entry: 1. Patient must be ≥ 18 years of age and must have provided written informed consent. 2. Histologically confirmed adenocarcinoma of the prostate without neuroendocrine or small cell differentiation. 3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 (see Appendix 1). 4. For dose escalation (dose levels 1-9) and expansion cohorts, patients must have had at least one prior line of taxane (docetaxel) chemotherapy either in the hormone sensitive or castrate resistant setting unless the patient is deemed medically unsuitable for chemotherapy. If a patient has had docetaxel chemotherapy twice, this will be considered one line. For the continuous olaparib dose cohort (DE #2) patients can have had docetaxel however this is not required for eligibility. 5. Patients must have progressed on a second generation AR targeted agent (e.g. enzalutamide, abiraterone, darolutamide and/or apalutamide). Determination of disease progression on second generation AR targeted agent will be made by the local investigator. 6. Patients must have progressive disease for study entry. This is defined by PCWG3 as any one of the following:
• PSA progression: minimum of two rising PSA values from a baseline measurement with an interval of ≥ 1 week between each measurement. The PSA value at screening should be ≥ 10ng/ml.
• Soft tissue or visceral disease progression as per RECIST 1.1 criteria (see Appendix 2)
• Bone progression: ≥ 2 new lesions on bone scan (Appendix 2) 7. At least 3 weeks since the completion of surgery or radiotherapy prior to registration. Any clinically relevant sequelae from the surgery or radiotherapy must have improved to grade 1 prior to registration. 8. Prior surgical orchiectomy or chemical castration maintained on luteinizing hormone-releasing hormone (LHRH) analogue (agonist or antagonist). Patients without prior surgical castration must be currently taking and willing to continue luteinizing hormone-releasing hormone (LHRH) analogue (agonist or antagonist) therapy throughout the duration of study treatment. 9. Serum testosterone levels ≤ 50ng/dL (≤ 1.75nmol/L) within 28 days before registration. 10. Imaging evidence of metastatic disease documented with either bone scan or CT scan (Appendix 2). 11. Prior prostate cancer vaccine therapy, radiation therapy, systemic therapies, diethylstilboestrol (DES) or other estrogens, bicalutamide, flutamide or nilutamide are allowed up to 28 days prior to trial registration. Note: bicalutamide, flutamide or nilutamide must be discontinued within 4 weeks of registration. 12. Significant PSMA avidity on 68Ga/18F-PSMA PET/CT, defined as a minimum uptake of SUVmax 15 at a site of disease, and SUVmax > 10 at other sites of disease ≥10mm (unless subject to factors explaining a lower uptake, e.g. respiratory motion, reconstruction artefact). 13. Patients must have a life expectancy ≥ 24 weeks. 14. Patients must use a condom during treatment and for 3 months after the last dose of olaparib when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male patients should also use a highly effective form of contraception (see section 11.7.4 for acceptable methods). 15. Patients must be willing and able to comply with the protocol for the duration of the study including undergoing treatment, scheduled assessments including completing Patient Reported Outcomes (PRO) instruments. 16. Patients must have adequate bone marrow, hepatic and renal function documented within 28 days prior to registration, defined as:
• Haemoglobin ≥ 100 g/L independent of transfusions (no red blood cell transfusion in last 8 weeks)
• Absolute neutrophil count ≥ 1.5x109/L
• Platelets ≥ 150 x109/L
• Total bilirubin ≤ 1.5 x upper limit of normal (ULN) except for patients with known Gilbert's syndrome where this applies for the unconjugated bilirubin.
• Aspartate transaminase (AST) (SGOT) and alanine transaminase (ALT) (SGPT) ≤ 2.5 x ULN if there is no evidence of liver metastasis or ≤ 5 x ULN in the presence of liver metastases.
• Albumin ≥ 30 g/L
• Adequate renal function: patients must have creatinine clearance estimated of ≥ 51 mL/min using the Cockcroft-Gault equation or based on a 24 hour urine test to appendix 5). 17. Patients who are deemed by PSMA imaging to have readily accessible disease will be required to consent to 3 serial tumour biopsies
• at screening, post combination treatment (at any time between weeks 2-4) and in the event of disease progression.

Exclusion Criteria:

• Patients must not meet any of the following criteria for study entry: 1. Site(s) of disease that are FDG positive with low PSMA expression defined by PSMA SUVmax < 10. 2. Extensive marrow disease defined by a "Super Scan" on bone scintigraphy or diffuse marrow infiltration on PSMA PET. 3. Previous history or presence of brain metastases or leptomeningeal metastases. A scan to confirm the absence of brain metastases is not required if there is no clinical history of this. 4. Surgery or radiotherapy within < 3 weeks of registration (except for palliative reasons). Patients must have recovered from any effects of any major surgery. 5. Patients with symptomatic or impending cord compression unless appropriately treated beforehand and clinically stable for ≥ 4 weeks. 6. Any prior exposure to 177Lu-PSMA, cabazitaxel, platinums, PARP inhibitors, mitoxantrone or cyclophosphamide. 7. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, recent thromboembolic events (<6 months ago), uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or psychiatric illness/social situations that is likely to impede participation and /or compliance in the study. 8. Persistent toxicities [Common Terminology Criteria for Adverse Event (CTCAE) ≥ grade 2] caused by previous cancer therapy, excluding alopecia. 9. Other malignancies within the previous 2-years other than basal cell or squamous cell carcinomas of skin or other cancers that are unlikely to recur within 24 months. 10. Previous history of interstitial lung disease or non-infectious pneumonitis. 11. Patients with a history or clinical features suggestive of myelodysplastic syndrome / acute myeloid leukaemia. 12. Patients unable to swallow orally administered medications or with gastrointestinal disorders likely to interfere with the absorption of the study medication. 13. Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (e.g., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation > 500 ms, electrolyte disturbances, etc.), or patients with congenital long QT syndrome. 14. Known hypersensitivity to olaparib or any of the excipients of olaparib. 15. Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV1/2). Only need to check this if there is a clinical history. HIV-infected (HIV1/2 antibody-positive) patients may participate if they meet all the following eligibility requirements:
• They must be on an anti-retroviral regimen with evidence of at least two undetectable viral loads within the past 6 months on this same regimen; the most recent undetectable viral load must be within the past 12 weeks.
• They must have a CD4 count ≥ 250 cells/µL over the past 6 months on this same anti-retroviral regimen and must not have had a CD4 count < 200 cells/µl over the past 2 years, unless it was deemed related to the cancer and/or chemotherapy-induced bone marrow suppression.
• For patients who have received chemotherapy in the past 6 months, a CD4 count < 250 cells/µl during chemotherapy is permitted as long as viral loads were undetectable during this same chemotherapy.
• They must have an undetectable viral load and a CD4 count ≥ 250 cells/µL within 7 days of enrolment.
• They must not be currently receiving prophylactic therapy for an opportunistic infection and must not have had an opportunistic infection within the past 6 months. 16. Patients with known active hepatitis (i.e. Hepatitis B or C). Only need to check this if there is a clinical history.
• Active hepatitis B virus (HBV) is defined by a known positive HBV surface antigen (HBsAg) result. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody and absence of HBsAg) are eligible.
• Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. 17. Concomitant use of known strong CYP3A inhibitors (e.g. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks. 18. Concomitant use of known strong (e.g. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (eg. bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for phenobarbital and enzalutamide and 3 weeks for other agents. 19. Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT). 20. Participation in another clinical study with an investigational product or another systemic therapy administered in the last 3 weeks.

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Condition: Prostate Tumors

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01727284

Sponsor: Mayo Clinic

Eligibility:

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

Inclusion Criteria:

• Patients with "biopsy proven" soft tissue tumor recurrences of prostate fossa
• Surgery is not a desirable alternative therapy at the time of enrollment
• Radiation therapy has failed or not indicated or can be safely postponed
• Tumor size is < 5 cm at its largest diameter
• Tumor does not encompass the rectal wall or external urethral sphincter
• Patient is able to undergo MRI

Exclusion Criteria:

• N/A

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Condition: Recurrent Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03246802

Sponsor: British Columbia Cancer Agency

Eligibility:

• Age: minimum 45 Years maximum 80 Years
• Gender: Male

Inclusion Criteria:

• Age >45 and Life expectancy >10 years
• Previous External Beam Radiotherapy (EBRT) dose up to 78Gray/39 fractions, 81 Gray/45 fractions or 70 Gray/28 fractions
• > 3 year interval since EBRT
• No late toxicity from prior EBRT > grade 2
• Rising PSA post EBRT > nadir + 2 ng/ml but < 10 ng/ml
• PSA Doubling time > 6 months
• Negative staging with CT scan of the abdomen/pelvis and bone scan
• Able to undergo multiparametric MRI with endorectal coil
• Radiographic evidence of dominant intraprostatic lesion (DIL) as only area of recurrence (i.e unifocal recurrence) and corresponding to site of original disease
• Biopsy confirmation of DIL with pathology review by British Columbia Cancer Agency GenitoUrinary pathologist (TB)
• Willing to provide informed consent
• History and physical examination within 90 days of registration
• ECOG performance status 0-1 prior to registration
• IPSS < 16, or adequate voiding study (post void residual < 100cc and peak flow rate > 10 cc/second).
• No prior trans urethral prostatic resection
• Recurrence suitable for implant with HDR brachytherapy as assessed on ultrasound simulation (maximum PTV ideally < 65% of prostate volume)
• No history of inflammatory bowel disease or previous rectal surgery
• Suitable for procedure under anesthesia, spinal or general
• INR <2.5 and platelet count >75 x 109/L
• Androgen Deprivation Therapy may be initiated at the discretion of the treating oncologist

Exclusion Criteria:

• Not compliant with criteria above
• Unable to give informed consent

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Condition: Castration Resistant Prostate Cancer (CRPC), Small Cell Lung Cancer (SCLC), Follicular Lymphoma (FL)

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03460977

Sponsor: Pfizer

Phase: Phase 1

Eligibility:

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

Key Inclusion Criteria:

• Histological or cytological diagnosis of advanced / metastatic solid tumor with the following tumor types in individual study parts: Part 1A (closed to enrollment): Part 1B (closed to enrollment): Part 1C:
• Castration resistant prostate cancer. Patients should have received either abiraterone and/or enzalutamide treatment and have evidence of prostate cancer progression (per PCWG3) Japan cohort
• Castration resistant prostate cancer that is resistant to SOC or for which no local regulatory approved SOC is available that would confer significant clinical benefit in the medical judgement of the investigator. Patients should have received either abiraterone and/or enzalutamide treatment and have evidence of prostate cancer progression (per PCWG3) China cohort
• Castration resistant prostate cancer that is intolerant/resistant to SOC or for which no local regulatory approved SOC is available that would confer significant clinical benefit in the medical judgement of the investigator. Patients who refused SOC may be eligible. Patients should have received either abiraterone and/or enzalutamide treatment and have evidence of prostate cancer progression (per PCWG3) Part 2A: • Castration resistant prostate cancer. Patients should have received either abiraterone and/or enzalutamide treatment, may have received up to 1 line of chemotherapy and have evidence of prostate cancer progression (per PCWG3) Part 2B:
• Castration resistant prostate cancer. Patients should have received abiraterone treatment, may have received up to 1 prior line of chemotherapy, have not received prior enzalutamide, apalutamide or darolutamide and have evidence of prostate cancer progression (per PCWG3)
• Patients must have radiographic evidence of disease Other

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
• Adequate organ function

Key Exclusion Criteria:

• Prior Chemotherapy: Part 1C , Japan cohort and China cohort (CRPC): no more than 2 previous regimens of chemotherapy Part 2A: CRPC: no more than 1 previous regimen of systemic chemotherapy Part 2B (CRPC): no more than 1 previous regimen of chemotherapy
• Prior irradiation to >25% of the bone marrow.
• QTcF interval >480 msec at screening.
• Hypertension that cannot be controlled by medications (>150/90 mmHg despite optimal medical therapy).
• Known or suspected hypersensitivity to PF 06821497 or any components or enzalutamide (CRPC)
• Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease or previous gastric resection or lap band surgery. Gastroesophageal reflux disease under treatment with proton pump inhibitors is allowed.
• Current use or anticipated need for food or drugs that are known strong CYP3A4/5 inducers or inhibitors, including their administration within 10 days or 5 half lives of the CYP3A4/5 inhibitor, whichever is longer prior to first dose of investigational product.

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Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01607008

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility:

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

Inclusion Criteria:

• Histologically-confirmed prostate cancer
• Plan to undergo external radiation treatment of prostate cancer

Exclusion Criteria:

• Patients who cannot undergo an MRIs
• Patients who are allergic to gadolinium based contrast agent
• Patients who have cardiac pacemaker or other electronic or metal implant
• Patients who have chronic kidney disease

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Condition: Metastatic Castration-resistant Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03230734

Sponsor: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

• 1. Patients must have histologically or cytologically confirmed adenocarcinoma of prostate 2. Two or more bone metastases confirmed by bone scintigraphy within 4 weeks prior to study entry 3. Symptomatic disease defined as regular use of opioid or non-opioid analgesic medication or treatment with external beam radiation therapy within the previous 12 weeks for cancer-related bone pain 4. Known castration-resistant disease, defined according to the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria as: castrate serum testosterone level: ≤50 ng/dL (≤1.7 nmol/L) 5. Subjects who have failed initial hormonal therapy, either by orchiectomy or by using a gonadotropin-releasing hormone (GnRH) agonist in combination with an anti-androgen, must first progress through antiandrogen withdrawal prior to being eligible. The minimum timeframe to document failure of anti-androgen withdrawal will be four weeks 6. Progressive disease based on prostate-specific antigen (PSA) and/or radiographic PCWG3 criteria:
• Serum PSA progression defined as two consecutive increases in PSA over a previous reference value within 6 months of first study treatment, each measurement at least one week apart. Serum PSA at screening ≥ 1ng/mL is the minimal starting value
• or radiographic disease progression based on documented bone lesions by the appearance of two or more new lesions by bone scintigraphy 7. Patients who failed treatment with any Androgen deprivation therapy (ADT) abiraterone and/or enzalutamide for CRPC that must be terminated at least 4 weeks before study entry. 8. Male, aged ≥18 years. 9. Life expectancy of greater than 6 months. 10. Eastern Cooperative Oncology Group (ECOG) performance status≤2 . 11. Patients must have normal organ and marrow function as defined below:
• leukocytes >3,000 x 10 9/L
• absolute neutrophil count >1,500 x 10 9/L
• platelets >100,000 x 10 9/L
• total bilirubin within normal institutional limits
• aspartate aminotransferase (AST/SGOT)/alanine aminotransferase (ALT/SGPT) <2.5 X institutional upper limit of normal
• creatinine within normal institutional limits 12. Male patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (1 of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 6 months after the last dose of radium-223 or docetaxel, according to guideline "Recommendation related to contraception and pregnancy testing in clinical trials", (2014_09_15 section 4.1) . Two acceptable methods of birth control thus include condom (barrier method of contraception) and one of the following is required (established use of oral, or injected or implanted hormonal method of contraception by the female partner; placement of an intrauterine device (IUD) or intrauterine system (IUS) by the female partner; additional barrier method like occlusive cap with spermicidal foam/gel/film/cream/suppository in the female partner; tubal ligation in the female partner; vasectomy or other procedure resulting in infertility (eg, bilateral orchiectomy), for more than 6 months. 13. No evidence (within 5 years) of prior malignancies (except successfully treated basal cell or squamous cell carcinoma of the skin). 14. Participant is willing and able to give informed consent for participation in the study.

Exclusion Criteria:

• 1. Patients who have had previous chemotherapy. 2. Patients who have had radiotherapy within 4 weeks prior to entering the study. 3. Participation in another clinical trial with any investigational agents within 30 days prior to study screening. 4. Concurrent use of other anticancer agents or treatments, with the following exceptions: luteinizing hormone-releasing hormone (LHRH) agonists or antagonists, denosumab or bisphosphonate (eg, zoledronic acid). Ongoing treatment should be kept at a stable schedule; however, if medically required, a change of dose, compound, or both is allowed. 5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 6. Patients who received systemic radiotherapy (e.g. samarium, strontium etc.) for the treatment of bone metastases. 7. Patients who received blood transfusion or erythropoietin within the last 4 weeks prior to start of study treatment. 8. Patients who received prior treatment with Radium-223. 9. Patients with malignant lymphadenopathy exceeding 3 cm in short-axis diameter, or symptomatic nodal disease, i.e. scrotal, penile or leg edema. 10. Other primary tumor (other than CRPC) including hematological malignancy present within the last 5 years (except non-melanoma skin cancer or low-grade superficial bladder cancer). 11. Maintenance treatment with corticosteroids corresponding to a prednisolone or prednisone dose above 10 mg/day. The dose must have been stable for at least 5 days. 12. Patients with imminent or established spinal cord compression based on clinical findings and/or magnetic resonance imaging. 13. Positive test for HIV 14. Patients with active hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C
• Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen (anti-HBc) antibody test) are eligible.
• Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.

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Condition: Metastatic Prostate Carcinoma, Recurrent Prostate Carcinoma, Stage IV Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02935205

Sponsor: Mamta Parikh

Phase: Phase 1/Phase 2

Eligibility:

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

Inclusion Criteria:

• Patients must have histologically or cytologically confirmed prostate cancer (CaP); CaP can be recurrent disease after definitive therapy (radical prostatectomy or radiation therapy) for localized CaP, or metastatic CaP
• Patients must have CaP deemed to be castration-resistant by one or more of the following criteria (despite androgen deprivation when applicable):
• Progression of unidimensionally measurable disease assessed within 42 days prior to initial administration of drug
• Progression of evaluable but not measurable disease assessed within 42 days prior to initial administration of drug for PSA evaluation and for imaging studies (e.g, bone scans)
• Rising PSA, defined as at least two consecutive rises in PSA to be documented over a reference value (measure 1); the first rising PSA (measure 2) should be taken at least 7 days after the reference value; a third confirmatory PSA measure (2nd beyond the reference level) should be greater than the second measure, and it must be obtained at least 7 days after the 2nd measure; if this is not the case, a fourth PSA measurement is required to be taken and be greater than the second measure
• Measurable disease is not required
• Patients who have measurable disease must have had X-rays, scans or physical examinations used for tumor measurement completed within 28 days prior to initial administration of drug
• Patients must have non-measurable disease (such as nuclear medicine bone scans) and non-target lesions (such as PSA level) assessed within 28 days prior to initial administration of drug
• Soft tissue disease that has been radiated within two months prior to registration is not assessable as measurable disease; soft tissue disease that has been radiated two or more months prior to registration is assessable as measurable disease provided that the lesion has progressed following radiation; as the biology of previously irradiated tumors may be different from non-irradiated tumors, patients must have at least one measurable lesion outside the previously irradiated region in order to be considered to have measurable disease
• If PSA is the only indicator of disease and patients do not have any metastatic disease, PSA value must be 5.0 or higher
• Patients must have been surgically or medically castrated; if the method of castration was luteinizing hormone-releasing hormone (LHRH) agonists (leuprolide or goserelin) or antagonists (degarelix), then the patient must be willing to continue the use of LHRH agonists or antagonists; serum testosterone must be at castration levels (< 50 ng/dL) within 3 months prior to registration
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
• Life expectancy of greater than 6 months
• Leukocytes >= 3,000/mcL
• Absolute neutrophil count >= 1,500/mcL
• Platelets >= 100,000/mcL
• Total bilirubin within normal institutional limits
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 1.5 x institutional upper limit of normal
• Creatinine =< 1.5 x institutional upper limit of normal
• 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 enzalutamide administration
• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

• Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
• Patients who are receiving any other investigational agents within the preceding 4 weeks
• Patients on herbs or other alternative medicines for the treatment of prostate cancer, including but not limited to saw palmetto, PC-SPES
• Patient has received enzalutamide or ketoconazole for the treatment of prostate cancer; however, previous treatment with other hormonal therapy (bicalutamide, abiraterone, flutamide, and nilutamide) or chemotherapy (docetaxel, cabazitaxel, or mitoxantrone) is allowed
• Other malignancies within the past 3 years except for adequately treated basal or squamous cell carcinomas of the skin or other stage 0 or I cancers
• Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to enzalutamide or indomethacin
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible
• Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of drugs (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
• Patients with an active bleeding diathesis
• History of noncompliance to medical regimens
• Patients unwilling to or unable to comply with the protocol
• Patients with symptomatic metastatic prostate cancer such as moderate to severe pain, impaired organ function, or spinal cord compression will be excluded from this study unless these issues have been taken care of
• Patients with a history of seizure disorder, underlying brain injury with loss of consciousness, transient ischemic attack within the past 12 months, cerebral vascular accident, brain metastases, brain arteriovenous malformation
• Patients with a history of peptic ulcer disease or gastrointestinal bleeding

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Condition: Male Erectile Disorder, Prostate Cancer, Therapy-related Toxicity, Urinary Incontinence

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01194648

Sponsor: University College, London

Eligibility:

• Age: minimum N/A maximum 90 Years
• Gender: Male

Criteria: 1. Histologically proven prostate cancer on trans-rectal or transperineal template prostate biopsies. 2. Prostate biopsy (either TRUS or MRI Targeted or Template): - TRUS biopsy: up to burden bilateral disease with maximum 3mm one biopsy on non-dominant side is allowable. - MRI targeted and/or Template biopsy within 12 months of entry showing: - unilateral disease minimum 3mm of Gleason 3+3 or any Gleason 3+4 or 4+3 but not exceeding Gleason 4+3 overall OR - bilateral disease presence of clinically significant cancer on only one side (as determined by histological rules described above) Gleason ≤7 which is concordant with the MRI findings. 3. Stage T1-T2cN0M0 disease, as determined by local guidelines (radiological T3a permitted). 4. Serum PSA /=10 years. 6. Signed informed consent by patient. 7. An understanding of the English language sufficient to understand

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