Select Ongoing Trials Currently Enrolling Patients with Prostate Cancer

September 2016, Vol 6, No 9 - Clinical Trials Tracker


The following clinical trials represent a selection of key studies currently recruiting patients with prostate cancer for inclusion in investigations of new therapies and new regimens of existing treatments for patients with prostate cancer. Each clinical 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 Enzalutamide Monotherapy or in Combination with Abiraterone and Prednisone in Patients with Metastatic CRPC

This phase 3, randomized, open-label, parallel-assignment clinical trial assesses the efficacy of enzalutamide (Xtandi) with or without abiraterone (Zytiga) and prednisone in patients with metastatic castration-resistant prostate cancer (CRPC). Men aged ≥18 years with documented disease-progressive CRPC and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 may be eligible for enrollment if other criteria are met. Eligible patients will receive enzalutamide monotherapy or enzalutamide in combination with abiraterone and prednisone.

The primary outcome measure is overall survival (OS). The secondary outcome measures include grade ≥3 toxicity, prostate-specific antigen (PSA) levels, radiographic progression-free survival (PFS), objective response rate, ability of radiographic PFS to predict OS, tumor burden and bone activity, and development and validation of prognostic and predictive models of OS. This study expects to enroll 1224 patients at multiple locations across the United States and Canada. For more information, contact Michael Morris, MD, at 646-422-4469. The NLM Identifier is NCT01949337.

2 Enzalutamide in First-Line ADT for Metastatic Prostate Cancer: The ENZAMET Study

The purpose of this randomized, open-label, parallel-assignment, phase 3 clinical trial is to determine the efficacy of enzalutamide versus a conventional nonsteroidal anti­androgen (NSAA) therapy, when combined with a luteinizing hormone-releasing hormone analog or surgical castration, as first-line androgen-deprivation therapy (ADT) for patients with newly diagnosed metastatic prostate cancer. Men aged ≥18 years with metastatic adenocarcinoma of the prostate and an ECOG performance status of 0 to 2 may be eligible for enrollment if other criteria are met. Eligible patients will receive enzalutamide or conventional NSAA.

The primary outcome measure is OS. The secondary outcome measures include PSA PFS, clinical PFS time, adverse events, health-related quality of life, and healthcare resource cost-effectiveness. This study plans to enroll 1100 patients at multiple locations across the United States and abroad. For more information, contact the ENZAMET trial coordinator at enzamet@ctc.usyd.edu.au. The NLM Identifier is NCT02446405.

3 Cabazitaxel and Pelvic Radiotherapy in Localized Prostate Cancer and High-Risk Features of Relapse: The PEACE2 Study

The purpose of this randomized, open-label, factorial-assignment, phase 3 clinical trial is to assess the effect of neoadjuvant cabazitaxel (Jevtana) and pelvic radiotherapy in combination with ADT radiotherapy on clinical PFS in patients with high-risk localized prostate cancer (with a stringent selection of patients with at least 2 high-risk features), in a 2 × 2 factorial study. Men aged 18 to 75 years with stage T3 or T4 prostate cancer and a Gleason score ≥8 may be eligible for enrollment if other criteria are met. Patients will receive ADT plus pelvic radiotherapy, ADT plus cabazitaxel and prostate radiotherapy, ADT plus cabazitaxel and pelvic radiotherapy, or ADT plus prostate radiotherapy.

The primary outcome measure is PFS. The secondary outcome measures include PSA response at 3 months, biochemical PFS, metastases-free survival, local relapse-free survival, OS, prostate cancer–specific survival, acute toxicity, impact of treatment on serum testosterone, long-term toxicity, predictive biomarkers on treatment efficacy, and quality of life. This study plans to enroll 1048 patients at the Institut Gustave Roussy in Villejuif, France. For more information, contact Karim Fizazi, MD, PhD, at fizazi@igr.fr, or Pierre Blanchard at pierre.blanchard@gustaveroussy.fr. The NLM Identifier is NCT01952223.

4 ADT plus TAK-700 versus ADT plus Bicalutamide for Metastatic Prostate Cancer

This randomized, open-label, parallel-assignment, phase 3 study will compare OS in patients with newly diagnosed metastatic prostate cancer assigned to receive ADT plus TAK-700 versus ADT plus bicalutamide. Men aged ≥18 years with a clinical diagnosis of metastatic prostate cancer, Zubrod performance status of 0 to 2, and PSA ≥2 ng/mL may be eligible for enrollment if other criteria are met. Eligible patients will receive ADT plus TAK-700 or ADT plus bicalutamide.

The primary outcome measure is OS. This study expects to enroll 1486 patients at multiple locations across the United States. For more information, contact Jennifer I. Scott at 210-614-8808 ext 1007 or jscott@swog.org, or Dana B. Sparks at 210-614-8808 ext 1004 or dsparks@swog.org. The NLM Identifier is NCT01809691.

5 Medical and Economic Evaluation of External Beam Radiotherapy Alone or with Brachytherapy for Intermediate-Risk Prostate Cancer

The objective of this randomized, open-label, parallel-assignment, phase 3 clinical trial is 2-fold—(1) to show superiority of external beam radiotherapy combined with a brachytherapy boost versus exclusive external beam radiotherapy, and (2) to evaluate the economic impact of each treatment. Men aged 18 to 80 years with histologically confirmed prostate adenocarcinoma and a life expectancy of >10 years may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive brachytherapy boost with external beam radiotherapy or beam irradiation alone.

The primary outcome measure is biochemical relapse-free survival. The secondary outcome measures include OS, specific survival, survival without any metastatic evolution, toxicities, and medical and economic evaluation. This study plans to enroll 298 patients at Hospices Civils de Lyon in Pierre-Bénite, France. For more information, contact Olivier Chapet, MD, at olivier.chapet@chu-lyon.fr, or Julien Berthiller at julien.berthiller@chu-lyon.fr. The NLM Identifier is NCT02271659.

6 Radium 223 Dichloride After Intermittent ADT in Localized Prostate Cancer

The purpose of this phase 2, randomized, open-label, parallel-assignment clinical trial is to evaluate the efficacy and safety of monthly radium 223 dichloride (Xofigo) in prolonging the off-treatment interval for men with localized prostate cancer receiving intermittent androgen ablation therapy for a rising PSA level postradiation or postprostatectomy, who are at high risk for occult metastases. Men aged 45 to 85 years with a Gleason score of >8, and with PSA levels >5 ng/mL and <100 ng/mL and rising on 2 successive occasions at least 1 month apart before ADT, may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive radium 223 dichloride or no treatment.

The primary outcome measures are PSA levels >5 ng/mL and time to PSA levels >5 ng/mL in the off-treatment interval during intermittent androgen ablation therapy, as measured from randomization. This study plans to enroll 106 patients at the Sunnybrook Health Sciences Centre in Ontario, Canada. For more information, contact Laurence Klotz, MD, at 416-480-4673. The NLM Identifier is NCT02656563.

7 Radium 223 Dichloride plus Abiraterone Acetate versus Abiraterone Acetate plus Placebo for Prostate Cancer

This phase 3, randomized, double-blind, parallel-assignment clinical trial is assessing whether the addition of radium 223 dichloride to standard treatment can prolong life and delay events specific for prostate cancer that has spread to the bone, such as painful fractures or bone pain that needs to be treated with an x-ray machine. Men aged ≥18 years with asymptomatic or mildly symptomatic prostate cancer; at least 2 bone metastases on bone scan within 4 weeks before randomization with no lung, liver, other visceral and/or brain metastases, medical or surgical castration with testosterone <50 ng/dL; and an ECOG performance status of 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients will receive radium 223 dichloride plus abiraterone and prednisone or placebo plus abira­terone and prednisone.

The primary outcome measure is symptomatic skeletal event-free survival. The secondary outcome measures include OS, time to opiate use for cancer pain, time to pain progression, time to cytotoxic chemotherapy, radiologic PFS, and safety and tolerability. This study plans to enroll 800 patients at multiple locations across the United States and abroad. For more information, contact Bayer Clinical Trials at 844-229-3710, or clinical-trials-contact@bayer.com, or Bayer@emergingmed.com. The NLM Identifier is NCT02043678.

8 Alpha-Blocker Rapaflo to Treat Symptoms in Patients with Prostate Cancer Undergoing Radiation Therapy

Many patients undergoing radiation therapy have symptomatic urinary problems, which can significantly diminish patients’ quality of life during and shortly after therapy. This randomized, open-label, parallel-assignment, phase 3 clinical trial compares standard-of-care Rapaflo versus preventive treatment with Rapaflo in patients with prostate cancer—regardless of their risk—whose treatment comprises radical radiation therapy. Men aged ≥18 years with clinical or radiologic diagnosis of stage T1a to T3b prostate cancer and a Karnofsky performance score of ≥70 may be eligible for enrollment if other criteria are met. Eligible patients will receive Rapaflo on day 1 of radiation therapy before symptoms onset and continue for 6 months (preventive Rapaflo therapy) or at the onset of symptomatic urinary problems caused by radiation therapy until symptoms disappear (standard Rapaflo therapy).

The primary outcome measure is the rate of increase and the mean difference from the baseline International Prostate Symptom Score (IPSS) with preventive Rapaflo versus standard Rapaflo. The secondary outcome measures include the rate of IPSS return to baseline and the rate of therapy dependence. This study plans to enroll 188 patients in Quebec, Canada. For more information, contact Karen Lai Wing Sun at 514-340-8222 ext 4785 or klaiwingsun@jgh.mcgill.ca, or Ravi A. Madan, MD, at 301-496-3493 or rm480i@nih.gov. The NLM Identifier is NCT02220829.

9 Enzalutamide plus Leuprolide in Nonmetastatic Prostate Cancer: The EMBARK Study

The purpose of this phase 3, randomized, double-blind, parallel-group assignment clinical trial is to assess the benefit of enzalutamide plus leu­prolide in patients with high-risk nonmetastatic prostate cancer that progresses after radical prostatectomy, radiotherapy, or both. Men aged ≥18 years with histologically or cytologically confirmed adenocarcinoma of the prostate at initial biopsy, without neuroendocrine differentiation, signet cell, or small-cell features, and with PSA doubling time ≤9 months may be eligible for enrollment if other criteria are met. Eligible patients will receive enzalutamide plus leuprolide, enzalutamide monotherapy, or placebo plus leuprolide.

The primary outcome measure is metastasis-free survival. The secondary outcome measures include OS, proportion of patients who remain treatment-free 2 years after suspension of study drug treatment at week 37 as a result of undetectable PSA levels, time to castration resistance, prostate cancer–specific survival, time to first symptomatic skeletal event, and safety. This study plans to enroll 1860 patients across the United States and abroad. For more information, contact Medivation Clinical Trial Disclosure at TrialDisclosure@Medivation.com, or Medivation Clinical Operations at 415-543-3470. The NLM Identifier is NCT02319837.

10 ARN-509 in Patients with High-Risk Prostate Cancer Receiving Primary Radia­tion Therapy: The ATLAS Study

The purpose of this randomized, double-blind, parallel-assignment, phase 3 study is to determine whether JNJ-56021927 plus a gonadotropin-releasing hormone (GnRH) agonist in participants with high-risk, localized or locally advanced prostate cancer who receive primary radiation therapy results in an improvement of metastasis-free survival. Men aged ≥18 years indicated and planned to receive primary radiation therapy for prostate cancer, with a Charlson Index ≤3 and an ECOG performance status of 0 or 1 may be eligible for enrollment if other criteria are met. Participants will be randomized to receive JNJ-56021927 for 28 months plus bicalutamide placebo for 4 months from randomization, or bicalutamide for 4 months plus JNJ-56021927 placebo for 28 months from randomization. All participants will receive a GnRH agonist for 28 months from randomization and radiation therapy to the prostate starting at approximately 8 weeks after randomization.

The primary outcome measure is metastasis-free survival. The secondary outcome measures include time to local-regional recurrence, time to CRPC, time to distant metastasis, and OS. This study expects to enroll 1500 patients at multiple locations across the United States and abroad. For more information, contact JNJ.CT@sylogent.com. The NLM Identifier is NCT02531516.

11 Apalutamide (ARN-509) in Nonmetastatic Castra­tion-Resistant Prostate Cancer: The SPARTAN Study

The purpose of this phase 3, double-blind, single-group assignment clinical trial is to evaluate the efficacy and safety of apalutamide in adult men with high-risk nonmetastatic CRPC. Men aged ≥18 years with prostate cancer without neuroendocrine differentiation or small-cell features with high risk for metastases and ECOG performance status of 0 or 1 may be eligible for enrollment if other criteria are met. Patients will receive apalutamide or placebo.

The primary outcome measure is metastasis-free survival. The secondary outcome measures include OS, time to symptomatic progression, time to initiation of cytotoxic chemotherapy, PFS, time to metastasis, number of participants with adverse events, plasma concentrations of apalutamide and metabolite ARN000308, and participants with changes in functional assessment and quality-of-life questionnaires. This study expects to enroll 1200 patients at multiple locations across the United States and abroad. For more information, contact JNJ.CT@sylogent.com. The NLM Identifier is NCT01946204.