Safety and Efficacy Study of Enzalutamide Versus Bicalutamide in Men With Prostate Cancer

Completed · Phase 2

Conditions studied: Prostate Cancer

In brief

The purpose of this study is to determine the safety and efficacy of enzalutamide vs bicalutamide in asymptomatic or mildly symptomatic patients with prostate cancer who have disease progression despite primary androgen deprivation therapy.

Key facts

Study ID

NCT01664923

Run by

Pfizer

People needed

396

Starts

2012-08-01

Expected to finish

2018-01-01

Last updated by the study team

2019-01-30

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Males age 18 or older;
• Histologically or cytologically confirmed adenocarcinoma of the prostate;
• Ongoing androgen deprivation therapy;
• Serum testosterone level ≤ 50 ng/dL (1.73 nmol/L) at the Screening visit;
• Progressive disease at study entry defined by prostate-specific antigen (PSA) progression and/or radiographic progression that occurred while the patient was on primary androgen deprivation therapy;
• Asymptomatic or mildly symptomatic from prostate cancer;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
• Estimated life expectancy of ≥ 12 months;
• Able to swallow the study drug and comply with study requirements.

You may not qualify if…

• Severe concurrent disease, infection, or co-morbidity;
• Known or suspected brain metastasis or active leptomeningeal disease;
• History of another invasive malignancy within the previous 5 years other than treated non-melanomatous skin cancer and American Joint Committee on Cancer (AJCC) Stage 0 or Stage 1 cancers that have a remote probability of recurrence;
• Absolute neutrophil count < 1,500/µL, or platelet count < 100,000/µL, or hemoglobin < 9 g/dL at the Screening visit;
• Total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 times the upper limit of normal (ULN) at the Screening visit;
• Creatinine > 2 mg/dL at the Screening visit;
• Albumin < 3.0 g/dL at the Screening visit;
• History of seizure or any condition that may predispose to seizure;
• Clinically significant cardiovascular disease;
• Gastrointestinal disorder affecting absorption (e.g., gastrectomy, active peptic ulcer disease within last 3 months);
• Major surgery within 4 weeks of enrollment;
• Use of opiate analgesics for pain from prostate cancer within 4 weeks of enrollment;
• Radiation therapy for treatment of the primary tumor within 3 weeks of enrollment;
• Prior radiation or radionuclide therapy for treatment of distant metastases;
• Prior ketoconazole, abiraterone, or cytotoxic chemotherapy for prostate cancer;
• Treatment with hormonal therapy or biologic therapy for prostate cancer within 4 weeks of enrollment;
• Use of antiandrogens within 4 weeks prior to enrollment;
• Prior disease progression, as assessed by the Investigator, while receiving bicalutamide;
• Participation in a previous clinical trial of enzalutamide or an investigational agent that inhibits the androgen receptor or androgen synthesis (patients who received placebo are acceptable);
• Use of an investigational agent within 4 weeks of enrollment;
• 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 for prostate cancer within 4 weeks of enrollment;
• 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.
• Open-Label Treatment Period:
• Inclusion Criteria:
• Received randomized double blind treatment in MDV3100-09 as follows:

Where it is running

• University of Alabama at Birmingham，IDS Pharmacy — Birmingham, Alabama, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Desert Springs Cancer Care — Scottsdale, Arizona, United States
• Arizona Oncology Associates, PC - HOPE — Tucson, Arizona, United States
• Arizona Oncology Associates, PC - HOPE — Tucson, Arizona, United States
• Urological Associates of Southern Arizona, PC — Tucson, Arizona, United States
• Urological Associates of Southern Arizona, PC — Tucson, Arizona, United States
• Southern California Permanente Medical Group — Anaheim, California, United States
• Kaiser Permanente Medical Center Lab Drawing Station — Antioch, California, United States
• Kaiser Permanente Medical Center Lab Drawing Station — Antioch, California, United States
• Kaiser Permanente Medical Center Lab Drawing Station — Fairfield, California, United States
• Kaiser Permanente Medical Center Lab Drawing Station — Gilroy, California, United States
• Southern California Permanente Medical Group — Los Angeles, California, United States
• Tower Urology — Los Angeles, California, United States
• UCLA Clark Urology Clinic — Los Angeles, California, United States
• UCLA Department of Pharmaceutical Services — Los Angeles, California, United States
• Kaiser Permanente Medical Center Lab Drawing Station — Martinez, California, United States
• Kaiser Permanente Medical Center Lab Drawing Station — Milpitas, California, United States
• Kaiser Permanente Medical Center Lab Drawing Station — Modesto, California, United States
• Kaiser Permanente Medical Center Lab Drawing Station — Moutain View, California, United States
• Kaiser Permanente Medical Center Lab Drawing Station — Napa, California, United States
• Kaiser Permanente Medical Center — Oakland, California, United States
• Kaiser Permanente Medical Center Lab Drawing Station — Pleasanton, California, United States
• Kaiser Permanente Medical Center Lab Drawing Station — Redwood City, California, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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