Prostate Cancer

{{header-clinical-trials-navigation}}

The Role of Androgen Deprivation Therapy In Cardiovascular Disease - A Longitudinal Prostate Cancer Study (RADICAL PC1) & A RAndomizeD Intervention for Cardiovascular and Lifestyle Risk Factors in Prostate Cancer Patients (RADICAL PC2)


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

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

Prospective Evaluation of CyberKnife Stereotactic Body Radiotherapy for Localized Prostate Cancer: Risk Stratified Monotherapy Versus Boost


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

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

International Registry for Men With Advanced Prostate Cancer (IRONMAN)


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

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

Diagnosing Clinically Significant Prostate Cancer in African American and White Men Phase II, Randomized Clinical Trial, Multi-center, MR-Guided vs. 12-core Systematic Random Biopsy, Localized Prostate Cancer


Condition: Health Status Unknown, Elevated PSA

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03234556

Sponsor: University of Southern California

Eligibility:

  • Age: minimum 40 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information
  • Note: HIPAA authorization may be included in the informed consent or obtained separately
  • Eastern Cooperative Oncology Group (ECOG) performance status of =< 1 within 3 months (93 days) prior to being registered for protocol
  • African-American or white men (Hispanic or non-Hispanic)
  • Prostate biopsy-naive or a single negative biopsy
  • Having elevated prostate specific antigen (PSA) (> 2.5 ng/ml) and no palpable nodule on digital rectal exam (DRE)
  • Ability to understand the willingness to sign a written informed consent
  • Patients must be willing to undergo a radiologic imaging before and after biopsy of the prostate
  • Patients must be willing to undergo a biopsy of the prostate

Exclusion Criteria:

  • Patients who have had chemotherapy or radiotherapy within 12 months of the study for other diagnoses not related to prostate cancer
  • Patients receiving any other investigational agents
  • 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
  • Patients with active inflammatory bowel disease
  • Patients who are unable to undergo MRI
  • Patients who had any surgery of the prostate including TURP (transurethral resection of the prostate)
  • Patients who had > 1 prior prostate biopsy

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

Phase I Feasibility Trial of Stereotactic Re-irradiation of Prostate Cancer Recurrence Within the Definitively Irradiated Prostate


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)

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

Fluorine-18 - 2-(3-(1-carboxy-5-[(6-[18F]Fluoro-pyridine-3-carbonyl)-Amino]-Pentyl)-Ureido)-Pentanedioic Acid (18F-DCFPyL) Positron Emission Tomography / Computed Tomography (PET/CT) for Assessment of Recurrent Prostate Cancer


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)

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

Hereditary Leiomyomatosis Renal Cell Cancer (HLRCC): Identification of the Disease Gene, and Characterization of the Predisposition to Renal Cancer


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

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Diseases


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.

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

Postoperative or Salvage Radiotherapy for Node Negative Prostate Cancer Following Radical Prostatectomy


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.

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

A Randomized Trial of Modifications to Radical Prostatectomy


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

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

Collection of Blood From Patients With Cancer, Other Tumors, or Tumor Predisposition Syndromes for Analysis of Genetic Differences in Drug Disposition


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

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

Biospecimen Acquisition From Human Subjects


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. Children will not be eligible.

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

Carbon Ion Radiotherapy for the Treatment of Localized Prostate Cancer


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

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

The Role of Stereotactic Body Radiotherapy in the Management of Castration-Resistant Prostate Cancer With Oligometastases: An Adaptive Phase II/III Randomized Trial.


Condition: Castration-resistant Prostate Cancer Patients With Oligometastases

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02685397

Sponsor: Sir Mortimer B. Davis - Jewish General Hospital

Phase: Phase 2/Phase 3

Eligibility:

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

Inclusion Criteria:

  1. Age 18 or older and willing and able to provide informed consent;
  2. Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features;
  3. Ongoing androgen deprivation therapy with a Gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomy (i.e., surgical or medical castration);
  4. Patients who have not had a bilateral orchiectomy must have a plan to maintain effective GnRH analogue therapy for the duration of the trial;
  5. Serum testosterone level ≤ 1.7 nmol/L (50 ng/dL) at the Screening visit;
  6. Patients receiving bisphosphonate therapy/Xgeva must have been on stable doses for at least 4 weeks;
  7. Progressive disease at study entry defined as one or more of the following three criteria that occurred while the patient was on androgen deprivation therapy as defined in eligibility criterion #3:
  8. PSA progression defined by a minimum of two rising PSA levels with an interval of ≥ 1 week between each determination. Patients who received an anti-androgen must have progression after withdrawal (≥ 4 weeks since last flutamide or ≥ 6 weeks since last bicalutamide or nilutamide). The PSA value at the Screening visit should be ≥ 2 μg/L (2 ng/mL);
  9. Metastatic disease documented by bone lesions on bone scan or by measurable soft tissue disease by CT/MRI. Patients whose disease spread is limited to regional pelvic lymph nodes, and previously radiated, are not eligible; i. Up to 5 metastatic sites ii. ≤ 4 tumours within any given organ system, excluding brain and liver (e.g. up to 4 bone metastases, or 4 lung metastases) iii. All sites of disease must be amenable to SBRT with no history of the metastases being irradiated; iv. In the case of a suspicious lesion in an unusual location such as lung or thoracic lymph nodes (without other abdominal lymph nodes), a biopsy should confirm prostate cancer origin.
  10. No prior cytotoxic chemotherapy for prostate cancer;
  11. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 or Karnofsky performance status of > 70% or higher;
  12. Patients and their female partners of childbearing potential must be willing to use two forms of contraception (one of which must include a condom as a barrier method of contraception during sexual activity) throughout the duration of the study starting at screening and continuing for 3 months after the last dose of study drug or per local guidelines where these require additional description of birth control methods. These contraceptive methods must include the following:
  13. The use of condoms (barrier method) AND one of the following:
  14. the use of oral, injected or implanted hormonal methods of contraception by a female partner;
  15. placement of an intrauterine device (IUD) or intrauterine system (IUS) by a female partner;
  16. additional barrier method, such as occlusive cap (diaphragm or cervical/vault cap) with spermicidal foam/gel/film/cream/suppository by a female partner;
  17. tube ligation in the female partner;
  18. vasectomy or other procedure resulting in infertility (eg. bilateral orchiectomy) for ≥ 6 months. If the patient's partner is a pregnant woman, the patient must use a condom during sexual activity during and for 3 months after treatment with enzalutamide.
  19. Patients must agree to not donate sperm while taking study drug
  20. Estimated life expectancy of ≥ 6 months;
  21. Ability to swallow the study drug whole and comply with study.

Exclusion Criteria:

  1. Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment;
  2. Known or suspected brain metastasis or active leptomeningeal disease;
  3. History of another malignancy within the previous 5 years other than curatively treated non-melanoma skin cancer;
  4. Absolute neutrophil count < 1,500/μL, platelet count < 100,000/μL, or hemoglobin < 5.6 mmol/L (9 g/dL) at the Screening visit (NOTE: patients may not have received any growth factors within 7 days or blood transfusions within 28 days of the hematologic laboratory values obtained at the Screening visit);
  5. Total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 times the upper limit of normal at the Screening visit;
  6. Creatinine > 177 μmol/L (2 mg/dL) at the Screening visit;
  7. Albumin < 30 g/L (3.0 g/dL) at the Screening visit;
  8. History of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke or significant brain trauma). Also, history of loss of consciousness or transient ischemic attack within 12 months of enrollment (Day 1 visit);
  9. Clinically significant cardiovascular disease including:
  10. Myocardial infarction within 6 months;
  11. Uncontrolled angina within 3 months;
  12. Congestive heart failure New York Heart Association (NYHA) class 3 or 4, or patients with history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or multi-gated acquisition scan performed within three months results in a left ventricular ejection fraction that is ≥ 45%;
  13. History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes);
  14. History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place;
  15. Hypotension as indicated by systolic blood pressure < 86 millimeters of mercury (mmHg) at the Screening visit;
  16. Bradycardia as indicated by a heart rate of < 50 beats per minute on the Screening ECG;
  17. Uncontrolled hypertension as indicated by systolic blood pressure > 170 mmHg or diastolic blood pressure > 105 mmHg at the Screening visit.
  18. Gastrointestinal disorder affecting absorption (e.g., gastrectomy, active peptic ulcer disease within last 3 months);
  19. Major surgery within 4 weeks of enrollment (Day 1 Visit);
  20. Use of opiate analgesics (eg. morphine, fentanyl, etc.) for pain from prostate cancer within 4 weeks of enrollment (Day 1 visit). This does not apply to non-morphine drugs like codeine;
  21. Radiation therapy for treatment of the primary tumour within 3 weeks of enrollment (Day 1 visit);
  22. Radiation or radionuclide therapy for treatment of metastasis;
  23. Primary disease not treated
  24. More than 5 metastases
  25. Hormone naïve prostate cancer patients
  26. Treatment with flutamide within 4 weeks of enrollment (Day 1 visit);
  27. Treatment with bicalutamide or nilutamide within 6 weeks of enrollment (Day 1 visit);
  28. Treatment with 5-α reductase inhibitors (finasteride, dutasteride), estrogens, cytproterone within 4 weeks of enrollment (Day 1 visit)
  29. Treatment with systemic biologic therapy for prostate cancer (other than approved bone targeted agents and GnRH-analogue therapy) or other agents with anti-tumour activity within 4 weeks of enrollment (Day 1 visit);
  30. History of prostate cancer progression on ketoconazole;
  31. Prior use, or participation in a clinical trial, of an investigational agent that blocks androgen synthesis (e.g., abiraterone acetate, TAK-700, TAK-683, TAK-448) or targets the androgen receptor (e.g., BMS 641988);
  32. Participation in a previous clinical trial of enzalutamide;
  33. Use of an investigational agent within 4 weeks of enrollment (Day 1 visit);
  34. Use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids greater than the equivalent of 10 mg of prednisone per day within four weeks of enrollment (Day 1 visit);
  35. Any condition or reason that, in the opinion of the Investigator, interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of safety data.

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

HDR Monotherapy for Prostate Cancer: A Feasibility Study of Focal Radiotherapy Yields


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02918253

Sponsor: University Health Network, Toronto

Eligibility:

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

Inclusion Criteria:

  • Age ≥ 18 years
  • ECOG performance status 0
  • 2
  • Histological evidence of prostate adenocarcinoma
  • Low- and favorable intermediate-risk prostate cancer
  • Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed
  • No contraindications to MRI:
  • Absent or unifocal intraprostatic disease (<2 separate/distinct lesions), on multiparametric MRI
  • Prostate gland size <80cc
  • Baseline IPSS <18
  • No TRUP within the past 6 months, nor large TURP defect
  • Absence of radiological evidence of regional or distant metastases (optional evaluation, at physician discretion)
  • No previous pelvic and/or prostate EBRT and/or brachytherapy
  • No contraindications to general anesthesia, or spinal/epidural anesthesia
  • Absence of bleeding diathesis and/or anti-coagulative therapy that cannot be temporarily ceased during brachytherapy
  • No contraindications to endorectal coil, surgically absent rectum, severe hemorrhoids or colorectal surgery
  • Negative past medical history of Ulcerative Colitis, Crohn's Disease, Ataxia Telangiectasia, or SLE
  • Absence of latex allergy
  • No other medical conditions deemed by the PI to make patient ineligible for prostate HDR brachytherapy

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

Phase II Study: [18F]DCFPyL PET/MRI for Personalizing Prostate Cancer Subclinical Metastatic Ablative MR-guided Radiotherapy (MRgRT)


Condition: Post Prostatectomy

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03160794

Sponsor: University Health Network, Toronto

Eligibility:

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

Criteria: - ECOG performance status of 0-2 - Absence of significant comorbidities rendering patient nor suitable for curative ablative approaches - No history of non-skin malignancy - Histological evidence of prostate adenocarcinoma on previous radical prostatectomy. - No use of any form of hormonal therapy in the previous 12 months, or intention to start HT at time of enrollment. - Normal serum testosterone level ascertained within 4-6 weeks of enrollment - Absence of known metastatic disease - Radiological studies without evidence of regional or distant metastases: CT abdomen-pelvis and bone scan within previous 3 months - Able to lie supine at least 60 minutes to comply with imaging and treatment. - Absence of impaired renal function (calculated GFR > 30mL/min) - Absence of sickle cell disease or other hemoglobinopathies - No other medical conditions deemed by the PI to make patient ineligible for PET/MR scanning or SABR No contraindications to MRI: - Subject must weigh <136kg (scanner weight limit) - Subject must not have pacemakers, cerebral aneurysm clips, shrapnel injury, or implantable electronic devices not compatible with MRI - Prior anaphylactic reaction to gadolinium Rising PSA after maximal local therapies (radical prostatectomy and either adjuvant or salvage radiotherapy): - Three documented PSA rises, at least 1 month apart from post radiotherapy. - PSA value >0.1 and < 3 ng/mL, within 4-6 weeks of enrollment - No use of any forms of ADT in the previous 12 months nor contemplated to be used at time of study enrollment. Salvage ADT to be started when PSA reaches a value of 6.0ng/ml or greater.

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

Germline Alterations of Tumor Susceptibility Genes in New York Cancer Patients


Condition: Breast Cancer, Bladder Cancer, Kidney Cancer, Colon Cancer, Prostate Cancer, Lung Cancer, Ovarian Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT00579514

Sponsor: Memorial Sloan Kettering Cancer Center

Eligibility:

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

Inclusion Criteria:

  • Patients with a histologic diagnosis of cancer of the colon, breast, bladder, kidney, testicles, lungs, prostate, head and neck, or lymphoid organs, who have donated a diagnostic blood sample as either an inpatient or outpatient at MSKCC.
  • All patients who have two or more histologic diagnoses of the same primary tumor type involving the above sites.
  • Patients of Ashkenazi Jewish ancestry with a histologic diagnosis of cancer of any type.
  • Samples ascertained as part of protocol 98-024A(1) are also eligible for ascertainment in this study.

Exclusion Criteria:

  • MSKCC patients without a histologic diagnosis of cancer of the breast, bladder, kidney, colon, testicles, lungs, prostate, or lymphoid malignancy (including all types of lymphoma) will not be eligible for the AMDeC sponsored component of the study.

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

Collection of Blood From Patients With Prostate Cancer


Condition: Cancer Of Prostate, Prostate Cancer, Prostatic Neoplasms, Metastatic Prostate Cancer, Prostate

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT00923221

Sponsor: National Cancer Institute (NCI)

Phase:

Eligibility:

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

Inclusion Criteria:

  1. Patients 18 years of age and older are eligible. Patients with a diagnosis of prostate cancer are eligible.

Exclusion Criteria:

  1. Children are not eligible.

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

Canary Prostate Active Surveillance Study


Condition: Prostatic Neoplasms

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT00756665

Sponsor: University of Washington

Phase:

Eligibility:

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

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the prostate.
  • Clinically localized prostate cancer: T1-2, NX or N0, MX or M0.
  • No previous treatment for prostate cancer (including hormonal therapy, radiation therapy, surgery, or chemotherapy).
  • ECOG Performance Status 0 or 1.
  • Patient has elected Active Surveillance as preferred management plan for prostate cancer.
  • Patient consent has been obtained according to local Institutional Review Board for acquisition of research specimens.
  • Patient is accessible and compliant for follow-up.
  • Prostate biopsy requirements: 1. If diagnosis was within one year of baseline visit, participant must have at least one biopsy with at least 10 cores. 2. If diagnosis was more than 1 year prior to baseline visit, participant must have a minimum of 2 biopsies, one of which must be within 2 years prior to baseline visit.

Exclusion Criteria:

  • Unwillingness or inability to undergo serial prostate biopsy.
  • History of other malignancies, except: adequately treated non-melanoma skin cancer or adequately treated superficial bladder cancer (Ta) or other solid tumors curatively treated with no evidence of disease for > 5 years.

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone Pet Imaging in Patients With Progressive Prostate Cancer


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT00588185

Sponsor: Memorial Sloan Kettering Cancer Center

Eligibility:

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

Inclusion Criteria:

  • Patients with histologically confirmed prostate cancer.
  • Progressive disease manifest by either:
  • Imaging modalities:
  • Bone Imaging: New osseous lesions on bone imaging (bone scintigraphy or NaF PET scan) and/or MRI or CT: An increase in measurable soft tissue disease, or the appearance of new sites of disease. Or
  • Biochemical progression: A minimum of three rising PSA values from a baseline that are obtained 1 week or more apart, or 2 measurements 2 or more weeks apart.
  • Visible lesions by either CT, bone imaging, or MRI consistent with disease.
  • Informed consent.

Exclusion Criteria:

  • Previous anaphylactic reaction to either FDHT or FDG
  • Hepatic: Bilirubin > 1.5 x upper limit of normal (ULN), AST/ALT >2.5 x ULN, albumin < 2 g/dl, and GGT > 2.5 x ULN IF Alkaline phosphatase > 2.5 x ULN
  • Renal: Creatinine >1.5 x ULN or creatinine clearance < 60 mL/min

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}