December 2015 Vol 6, NO 6

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Clinical Trials Tracker

Select Ongoing Trials Currently Enrolling Patients with Prostate Cancer

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 alvaro.martinez@rtsx.com. 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 mohammad.hirmand@medivation.com; or Kristina Wilson, at 415-543-3470, or kristina.wilson@medivation.com. 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—enzalutamide plus leuprolide, enzalutamide monotherapy, or placebo plus leuprolide.

The primary outcome measure is metastasis-free survival. Secondary outcome measures include overall survival, prostate cancer–specific survival, and time to castration resistance. This study plans to enroll 1860 patients at multiple locations across the United States and abroad. For more information contact William Novotny, MD, at 415-983-3066, or william.novotny@medivation.com; or Christian Lopez, at 415-829-4159, or christian.lopez@medivation.com. The NLM Identifier is NCT02319837.

6. Enzalutamide plus Everolimus for Patients with Metastatic Castrate-Resistant Prostate Cancer
This open-label, phase 1 trial is evaluating the safety and efficacy of enzalutamide combined with everolimus in patients with metastatic castrate-resistant prostate cancer who have never received chemotherapy or who have previously received docetaxel chemotherapy and had disease progression. Men aged ≥18 years with histologically confirmed prostatic adenocarcinoma, confirmed metastatic disease, and an ECOG performance status score of 0 to 2 may be eligible for enrollment if other criteria are met. Eligible patients will be given a combination of everolimus and enzalutamide.

The primary outcome measures are the optimal daily dose of everolimus in combination with a standard daily dose of enzalutamide; PSA response rate decline of >50%; serious and nonserious adverse events; and levels of everolimus in blood samples collected from patients before everolimus dosing. This study expects to enroll 43 patients at locations in Florida, Ohio, and Tennessee. For more information contact the Sarah Cannon Research Institute, at 877-691-7274, or askSarah@scresearch.net. The NLM Identifier is NCT02125084.

7. Abiraterone Acetate and Prednisone with/without Veliparib
This randomized, open-label, parallel-assignment, phase 2 study compares the efficacy of abiraterone acetate and prednisone plus veliparib versus abiraterone acetate and prednisone alone in patients with metastatic, hormone-resistant prostate cancer. Men aged ≥18 years with histologically or cytologically confirmed prostatic adenocarcinoma, an ECOG performance status score of 0 to 2 who have not had chemotherapy, radiotherapy, or oral antifungal agents in the past 3 weeks before entering the study may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to abiraterone acetate and prednisone or to abiraterone acetate and prednisone plus veliparib.

The primary outcome measure is confirmed PSA response rate for up to 2 years. Secondary outcome measures include objective response rates, progression-free survival, and rates of PSA decline. This study plans to enroll 148 patients at multiple locations across the United States. For more information contact Walter M. Stadler, at 773-702-4150, or wstadler@medicine.bsd.uchicago.edu. The NLM Identifier is NCT01576172.

8. ProstAtak as Adjuvant Therapy for Patients with Localized Prostate Cancer
The purpose of this phase 3, randomized, parallel-assignment, double-blind study is to evaluate the effectiveness of ProstAtak immunotherapy plus radiation therapy in patients with intermediate-risk to high-risk localized prostate cancer. Men aged ≥18 years with an ECOG performance status score of 0 to 2 and no liver disease or known sensitivities or allergies to acyclovir or valacyclovir who were planning to undergo standard, prostate-only, external-beam radiation therapy may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to ProstAtak plus valacyclovir and radiation therapy or to placebo plus valacyclovir and radiation therapy.

The primary outcome measure is disease-free survival, defined as the time from the date of randomization to the date of the patient’s first failure event. Secondary outcome measures include prostate cancer–specific survival and overall survival, changes to quality of life, and adverse events. This study expects to enroll 711 patients at multiple locations across the United States. For more information contact Kelly Szajna, RN, at 410-502-9242, or kszajna1@jhmi.edu; or Megan Kummerlowe, at 410-502-2971, or mkummer1@jhmi.edu. The NLM Identifier is NCT01436968.

9. Observational Study of Patients with Metastatic Prostate Cancer Receiving Docetaxel for Evaluation of Docetaxel Plasma Levels Using the MyDocetaxel Assay
This observational study is seeking to establish the target range of docetaxel exposure that is appropriate for patients with metastatic prostate cancer who are receiving docetaxel therapy. Men aged ≥18 years with histologically or cytologically confirmed prostatic adenocarcinoma and an ECOG performance status score of 0 to 2 who are about to start a new line of treatment with docetaxel plus prednisone may be eligible for enrollment if other criteria are met. Eligible patients will receive docetaxel therapy, and undergo blood draws for determination of docetaxel plasma levels and exposure.

Primary outcome measures are the variability of docetaxel exposure and treatment-related toxicities. Secondary outcome measures include frequency of growth factor use, time to PSA progression, and quality-of-life changes. This study plans to enroll 80 patients at multiple locations across Pennsylvania. For more information contact Craig Miller, BS, at 484-547-0540, or cmiller@saladax.com. The NLM Identifier is NCT02376296.

10. Posttreatment Carfilzomib for Patients with Metastatic, Castration-Resistant Prostate Cancer
This phase 2, open-label trial is evaluating the efficacy of carfilzomib in reducing prostate cancer progression in patients who previously received chemotherapy and androgen inhibitors. Men aged ≥18 years with histologically confirmed prostatic adenocarcinoma, metastatic and progressive disease, and an ECOG performance status score of 0 to 2 may be eligible for enrollment if other criteria are met. Eligible patients will receive carfilzomib, administered with dexamethasone as a premedication. Acyclovir will also be given during therapy but may be discontinued at some point; therapy continues until disease progression, withdrawal of the patient by the doctor, or if side effects become unacceptable.

The primary outcome measure is progression-free survival at 6 months. Secondary outcome measures include changes in PSA rate, circulating tumor-cell enumeration, and pain response. Toxicities and disease response rate are also measured. This study plans to enroll 28 patients in Alabama, Louisiana, and Georgia. For more information contact Pam Dixon, RN, BSN, OCN, at 205-975-9875, or pamdixon@uab.edu; or Guru Sonpavde, MD, at 205-975-3742, or sonpavde@uab.edu. The NLM Identifier is NCT02047253.

11. Phenelzine Sulfate for Patients with Nonmetastatic Recurrent Prostate Cancer
This open-label, phase 2 trial is studying the use of phenelzine sulfate as treatment for patients with recurrent prostate cancer that has not spread to other parts of the body. Men aged ≥18 years with histologically confirmed prostatic adenocarcinoma and recurrent prostate cancer who have no known history of mania or major psychiatric illness may be eligible for enrollment if other criteria are met. Eligible patients will receive phenelzine sulfate.

The primary outcome measure is a ≥50% decline in PSA rate. Secondary outcome measures include potential toxicities and/or beneficial effects on quality of life, time to radiographic disease progression, and the relationship between monoamine oxidase activity and prostate cancer. This study expects to enroll 46 patients in Beverly Hills, Los Angeles, and Pasadena, CA. For more information contact Charlean Ketchens, RN, at 323-226-8326, or charlean.ketchens@med.usc.edu. The NLM Identifier is NCT02217709.

12. Food Effect on the Pharmacokinetics and Pharmacodynamics of Abiraterone Acetate
The purpose of this randomized, open-label, parallel-assignment, phase 2 study is to examine the best way for patients with castration-resistant prostate cancer to receive abiraterone acetate. Men with histologically or cytologically confirmed prostate cancer, evidence of castration resistance, and an ECOG performance status score of 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients are randomized to abiraterone acetate after a night of fasting or after eating a conventional, low-fat breakfast.

The primary outcome measure is a change in PSA level from baseline to 12 weeks. Secondary outcome measures include progression-free survival, peak plasma concentration of abiraterone acetate, and the incidence of adverse events for up to 1 year. This study plans to enroll 72 patients in Georgia and Illinois. For more information contact Elia Martinez, RN, at 773-702-3623. The NLM Identifier is NCT01543776.

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