A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer

Completed · Phase 3 · Has a placebo group

Conditions studied: Prostate Cancer

In brief

The purpose of this study is to determine the benefit of enzalutamide versus placebo as assessed by overall survival and progression-free survival in patients with progressive metastatic prostate cancer who have failed androgen deprivation therapy but not yet received chemotherapy.

Key facts

Study ID

NCT01212991

Run by

Pfizer

People needed

1717

Starts

2010-09-16

Expected to finish

2019-02-14

Last updated by the study team

2020-03-17

Who can join

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

You may qualify if…

• Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
• Ongoing androgen deprivation therapy with a GnRH analogue or bilateral orchiectomy
• Progressive disease despite androgen deprivation therapy as defined by rising PSA levels or progressive soft tissue or bony disease
• No prior treatment with cytotoxic chemotherapy
• Asymptomatic or mildly symptomatic from prostate cancer

You may not qualify if…

• Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment
• Known or suspected brain metastasis or active leptomeningeal disease
• History of another malignancy within the previous 5 years other than curatively treated non-melanomatous skin cancer
• Open-Label Treatment Period:
• The following inclusion criteria apply to patients receiving enzalutamide or placebo during double-blind treatment.
• Eligible patients must meet all inclusion criteria.
• Received randomized double-blind treatment in PREVAIL;
• Open-label day 1 visit is within 6 months after this amendment is approved and becomes effective at the study site;
• Is willing to maintain androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) agonist/antagonist or has had a bilateral orchiectomy;
• The exclusion criteria apply only to patients starting new treatment with enzalutamide after receiving placebo as randomized treatment. Each patient must not meet any of the following criteria:
• Has taken commercially available enzalutamide (Xtandi);
• Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment
• Known or suspected brain metastasis or active leptomeningeal disease

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• The University of Arizona Cancer Center-North Campus — Tucson, Arizona, United States
• The University of Arizona Cancer Certer-North Campus — Tucson, Arizona, United States
• Cancer Center Oncology Medical Group — La Mesa, California, United States
• Keck Hospital of USC — Los Angeles, California, United States
• LAC&USC Medical Center — Los Angeles, California, United States
• USC/Norris Comprehensive Cancer Center / Investigational Drug Services — Los Angeles, California, United States
• USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Ronald Reagan UCLA Medical Center Drug Information Center Department of Pharmaceutical Services — Los Angeles, California, United States
• UCLA Clark Urology Clinic — Los Angeles, California, United States
• North County Oncology Medical Clinic, Inc — Oceanside, California, United States
• UC Davis Medical Center — Sacramento, California, United States
• University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
• Medical Oncology Associates-SD — San Diego, California, United States
• Sharp Memorial Hospital Investigational Pharmacy — San Diego, California, United States
• Sharp Rees-Stealy — San Diego, California, United States
• Stanford University Medical Center — Stanford, California, United States
• Anschutz Cancer Center Pavilion Pharmacy — Aurora, Colorado, United States
• University of Colorado Hospital, Anschutz Cancer Pavilion — Aurora, Colorado, United States
• Lynn Cancer Institute Center for Hematology Oncology — Boca Raton, Florida, United States
• Northwestern Medical Faculty Foundation — Chicago, Illinois, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Jewish Hospital & St. Mary's Healthcare, Inc. — Louisville, Kentucky, United States
• Brigham & Women's Hospital — Boston, Massachusetts, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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