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New Clinical Trials Under Way

February 2015, Vol 5, No 1

The following clinical trials are currently recruiting patients with prostate cancer for inclusion in several investigations. Each trial description includes the NLM Identifier to use as reference with ClinicalTrials.gov.

Radiation Therapy With or Without Androgen Deprivation Therapy

This phase 3, parallel assignment, open-label study examines the effectiveness of radiation therapy when it is given with or without androgen deprivation therapy comprising a lutein­izing hormone-releasing hormone (LHRH). Patients aged ≥18 years with prostate cancer may enroll if other criteria are met. Patients are randomized to receive (1) external-beam radiation therapy once daily on days 1 to 5 or (2) an LHRH agonist subcutaneously or as an injection every 1 to 3 months with oral flutamide or bicalu­tamide for 6 months. Beginning 8 weeks after the first LHRH injection, patients will undergo radiotherapy as in the non-LHRH group.

The primary objective is overall survival (OS), measured from the date of randomization to the date of death due to any cause. Secondary outcome measures include biochemical failure, local or regional disease recurrence, and distant metastasis. This study is expected to enroll 1520 patients at sites throughout the United States.

For more information, contact Alvaro Martinez, MD, FACR, at 248-553-0606 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT00936390.




Safety and Efficacy of Enzalutamide

This phase 3, parallel-assignment, double-blind study assesses the safety and efficacy of enzalutamide in patients with nonmetastatic prostate cancer. Patients aged ≥18 years who have ongoing androgen deprivation therapy with a gonadotropin-releasing hormone agonist/antagonist or prior bilateral orchiectomy may enroll if other criteria are met. Patients are randomized to placebo or 160 mg of enzalutamide daily.

The primary outcome measure is metastasis-free survival. Secondary outcome measures include OS, time to pain progression, or time to opiate use for prostate cancer pain. Time to first use of cytotoxic chemotherapy or new antineoplastic therapy, and time to prostate-specific antigen (PSA) progression are also collected. This study is expected to enroll 1560 patients at sites throughout the United States.

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.




DCVAC Added to Standard Chemotherapy

The objective of this phase 3, parallel-assignment, double-blind study is to determine whether DCVAC/PCa added to standard-of- care chemotherapy can improve survival times for patients with metastatic castration-resistant prostate cancer. Patients aged ≥18 years with disease progression despite androgen deprivation therapy, a life expectancy of ≥6 months, and an Eastern Cooperative Oncology Group performance status of 0 to 2 may enroll if other criteria are met. Patients are randomized to receive either DCVAC or placebo with standard-of-care therapy consisting of docetaxel and prednisone.

The primary outcome is OS, measured over a time frame of 124 weeks. Secondary outcome measures include radiographic progression-free survival (PFS), and duration to PSA progression and skeletal-related events. This trial is expected to enroll 1170 patients at several sites throughout the United States.

For more information, contact Richard Kapsa at This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT02111577.




Enzalutamide and Mifepristone

This phase 1/2 trial studies the side effects, efficacy, and best dose of enzalutamide and mifepristone combination therapy. Patients aged ≥18 years with metastatic hormone-resistant prostate cancer, an Eastern Cooperative Oncology Group performance status of ≤2, and evidence of castrate testosterone levels at <50 ng/dL may enroll if other criteria are met. Patients are randomized to receive either enzalutamide alone or in combination with mifepristone.

Primary outcomes are the recommended phase 2 dose, defined as the highest mifepristone dose in combination with enzalutamide, and PFS. Secondary outcome measures include OS, radiographic PFS, pharmacokinetic parameters of the 2 drugs, and the androgen and glucocorticoid receptors’ expressions within circulating tumor cells. This study is expected to enroll 108 patients in Chicago, IL.

For more information, contact Kelly O’Connor at 773-702-4653 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT02012296.




Enzalutamide plus Dutasteride as First-Line Treatment

The objective of this phase 2, open-label, single-group assignment study is to determine the effect of enzalutamide and dutasteride on the time to PSA level increase. Patients aged 65 to 85 years with prostate cancer who have a serum testosterone level of >1.7 nmol/L at time of screening and an Eastern Cooperative Oncology Group performance status of 0 to 2 may enroll if other criteria are met. All patients will receive daily enzalutamide and dutasteride orally.

The primary outcome measure is PSA levels, measured from blood drawn every 6 weeks for 103 weeks. This trial is expected to enroll 40 patients in Rochester, NY, and Milwaukee, WI.

For more information, contact Chunkit Fung, MD, at 585- 275-9319 or This email address is being protected from spambots. You need JavaScript enabled to view it., or Ayesha Khan at 585-275-3351 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT02213107.




Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate

The purpose of this phase 3, open- label, single-group assignment trial is to evaluate if leuprolide mesylate for injectable suspension (LMIS) is safe and effective in the treatment of advanced prostate carcinoma. Patients aged ≥18 years with a baseline morning serum testosterone level of >150 ng/dL and an Eastern Cooperative Oncology Group performance score of ≤2 may enroll if other criteria are met. All patients will be given 2 injections with a depot formulation of LMIS 50 mg at 6 months apart, and are followed until day 336.

The primary outcome measure is efficacy of the study drug. Secondary outcome measures include postsuppression excursions of serum testosterone, and the pharmacokinetics, safety, and tolerability of LMIS. This study is expected to enroll 130 patients at multiple sites throughout the United States.

For more information, contact John Mao, PhD, at 650-421-1016 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT02234115.




Calcitriol, Ketoconazole, and Hydrocortisone

This single-arm, phase 1/2 trial studies the side effects, best dose, and efficacy of calcitriol when given in combination with ketoconazole and hydrocortisone in patients with advanced or recurrent prostate cancer. Patients aged ≥18 years with an Eastern Cooperative Oncology Group performance status of 0 to 2 or a Karnofsky performance score of 60% to 100%, a life expectancy >3 months, and hemoglobin ≥8 g/dL may enroll if other criteria are met. All patients will receive oral calcitriol daily according to protocol. Patients will receive ketoconazole orally 3 times a day on days 1 to 24 and days 4 to 24 in phase 1 and 2 of the trial, respectively. Oral hydrocortisone is given in phase 1 of the trial only. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary outcome measures include the maximum tolerated dose of calcitriol as well as PSA response rate. Secondary outcome measures are toxicity and objective tumor response as measured by a monthly physical exam and radiographic evaluation every 12 weeks. This study is expected to enroll 51 patients in Buffalo, NY.

For more information, contact Donald L. Trump, MD, FACP, at 877-275-7724 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT00536991.




Metformin Prostate Cancer Adjuvant Trial

This open-label, phase 2 trial will determine whether metformin can increase the PSA doubling time for patients with prostate cancer who have failed primary treatment with radiation, or surgical patients who are at high risk for recurrence based on surgical pathology. Patients aged ≥18 years with hemoglobin A1c <7.0% who are able to swallow and retain oral medication may enroll if other criteria are met. All patients will receive metformin hydrochloride extended release 750 mg twice a day for 9 months, and are randomized to receive either surgery or radiation.

The primary outcome measure is PSA doubling time. The secondary outcome measure is the decrease in PSA levels. All end points are measured for a time frame of 9 months. This study is expected to enroll 70 patients in Mineola, NY.

For more information, contact Kaitlin Tietjen, MS, at 516-663-4721 or This email address is being protected from spambots. You need JavaScript enabled to view it., or Andrew Ho, BSc, at 516-535-1900 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT02176161.




Enzalutamide plus Leuprolide

The purpose of this phase 3, parallel-assignment, double-blind study is to assess the combination of enzalutamide and leuprolide in patients with high-risk, nonmetastatic prostate cancer that progresses after radical prostatectomy, radiotherapy, or both. Patients aged ≥18 years with PSA doubling time ≤9 months and a serum testosterone level of ≥150 ng/dL may enroll if other criteria are met. Patients are randomized to receive enzalutamide plus leuprolide, enzalutamide monotherapy, or placebo plus leuprolide.

The primary outcome measure is metastasis-free survival, measured for up to 56 months. Secondary outcomes include OS, the proportion of patients per group who remain treatment free 2 years after suspension of study drug treatment, and the time to castration resistance. Prostate cancer–specific survival, time to first symptomatic skeletal event, and safety and adverse event profiles are also measured. This trial is expected to enroll 1860 patients in Tucson, AZ; Omaha, NE; and Myrtle Beach, SC.

For more information, contact William Novotny, MD, at 415-983-3066 or william. This email address is being protected from spambots. You need JavaScript enabled to view it., or Christian Lopez at 415-829-4159 or christian. This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT02319837.

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