The following trials represent a selection of key clinical trials that are currently recruiting patients with prostate cancer for inclusion in investigations of new therapies or new combinations of available therapies for patients with prostate cancer. Each trial description includes the NLM Identifier to be used as a reference with ClinicalTrials.gov. The information below can help oncology practice managers and providers direct their eligible patients to one of these clinical trials.
1. Surgery with/without Docetaxel plus Leuprolide or Goserelin
This randomized, open-label, phase 3 study examines how well docetaxel and leuprolide or goserelin work when given before surgery versus surgery alone in patients with high-risk, localized prostate cancer. Men aged _18 years with histologically documented prostatic adenocarcinoma and an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to standard surgery alone or to docetaxel plus leuprolide or goserelin, followed by surgical intervention.
The primary outcome measure is the biochemical progression-free survival rate at 3 years. Secondary outcome measures include unacceptable toxicity, time to progression to metastatic disease, and the biochemical progression-free survival rate at 5 years. This study plans to enroll 750 patients at multiple locations across the United States. For more information contact James Eastham, MD, at 646-422-4390. The NLM Identifier is NCT00430183.
2. Dose-Escalated Radiotherapy with/without Androgen-Deprivation Therapy
This phase 3, randomized, parallel-assignment, open-label study compares the efficacy of radiation therapy alone versus radiation therapy with androgen-deprivation therapy in patients with prostate cancer. Men aged _18 years with histologically confirmed prostatic adenocarcinoma diagnosed within the past 180 days who have no evidence of bone metastases within the past 60 days and with clinically negative lymph nodes may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to external-beam radiation therapy alone or to androgen-deprivation therapy in addition to radiation therapy.
The primary outcome measure is overall survival, measured from the date of randomization to the date a patient dies (from any cause). Secondary outcome measures include prostate cancer_related and non_prostate cancer mortality, freedom from failure, and rate of salvage androgen-deprivation therapy. This study expects to enroll 1520 patients at multiple locations across the United States. For more information contact Alvaro A. Martinez, MD, FACR, at This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT00936390.
3. Androgen-Deprivation Therapy plus High-Dose Radiotherapy with/without Whole-Pelvic Radiotherapy
This phase 3, open-label, parallel-assignment study is comparing the use of androgen-deprivation therapy and high-dose radiotherapy with or without whole-pelvic radiotherapy in patients with unfavorable intermediate-risk or favorable high-risk prostate cancer. Men aged _18 years with no evidence of bone metastases in the 120 days before registration, no severe, active comorbidity, and clinically negative lymph nodes in the 90 days before registration may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to high-dose radiotherapy of the prostate and seminal vesicles or to whole-pelvic radiotherapy. Patients in both arms may also receive permanent prostate implant brachytherapy.
The primary outcome measure is overall survival. Secondary outcome measures include distant metastasis-free survival, fatigue status, and the incidence of acute adverse events. This study plans to enroll 2580 patients at multiple locations across the United States. For more information contact the University of California Davis Cancer, at 916-734-3089. The NLM Identifier is NCT01368588.
4. Efficacy and Safety of Enzalutamide in Patients with Nonmetastatic, Castration-Resistant Prostate Cancer
The purpose of this phase 3, double-blind, randomized, parallel-assignment study is to assess the safety and efficacy of enzalutamide in patients with nonmetastatic, castration-resistant prostate cancer. Men aged _18 years with histologically confirmed prostatic adenocarcinoma without neuroendocrine differentiation, signet cell, or smallcell features, an ECOG performance status score of 0 or 1, and an estimated life expectancy of _1 year may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to enzalutamide or to placebo.
The primary outcome measure is metastasis-free survival for _16 weeks. Secondary outcome measures include overall survival, quality of life, and time to pain progression. Time to opiate use for pain associated with prostate cancer, first use of cytotoxic chemotherapy, and progression of prostate-specific antigen (PSA) will also be measured. This study expects to enroll 1560 patients at multiple locations across the United States and abroad. For more information contact Mohammad Hirmand, MD, at 415-543-3470, or This email address is being protected from spambots. You need JavaScript enabled to view it.; or Kristina Wilson, at 415-543-3470, or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT02003924.
5. Enzalutamide with Leuprolide in Patients with High-Risk, Nonmetastatic Prostate Cancer
This phase 3, randomized, double-blind trial compares the efficacy and safety of enzalutamide plus leuprolide, enzalutamide alone, and placebo plus leuprolide in patients with high-risk, nonmetastatic prostate cancer that is progressing after definitive therapy. Men aged _18 years with histologically or cytologically confirmed prostatic adenocarcinoma and no present or previous evidence of distant metastatic disease who have not undergone previous systemic biologic therapy (including immunotherapy) for prostate cancer may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to 1 of 3 groups
