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4P-10-8: PREVAIL: A Multinational Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Oral MDV3100 in Chemotherapy-Nave Patients with Progressive Metastatic Prostate Cancer Who Have Failed Androgen Deprivation Therapy

Description

This is a research study for individuals who have been diagnosed with cancer of the prostate that is getting worse despite receiving hormone treatment. This study will use MDV3100, an experimental drug, that has not been approved for sale to the public by the United States Food and Drug Administration (US FDA) or other government and health regulatory agencies. The purpose of this study is to determine if MDV3100 will help the study participants live longer, if MDV3100 can delay the progression of cancer by increasing the amount of time before the cancer progresses, and to determine the safety of the study drug.MDV3100 is an experimental drug known as an androgen-receptor antagonist (it blocks the activity of the male sex hormones). It directly affects a key mechanism in the body that leads to prostate cancer cell death. Prostate cancers are initially dependent on the male hormone testosterone for growth. Hormonal therapies that lower testosterone or block the ability of testosterone to act at the level of the prostate cancer are currently among the most effective treatments for prostate cancers that have spread to other body organs (metastasized). The effectiveness of hormonal treatments, however, is not permanent, and over time many prostate cancers progress in spite of these treatments. This study is a multicenter, phase 3 double-blind placebo-controlled study. This study is a blinded study, which means that neither the study participants nor the study doctor will know if they are taking MDV3100 or placebo. The experimental drug, MDV3100 is provided as a 40 mg soft gelatin capsule and is indicated at a dose of 160 mg/day administered once daily. The study drug may be taken with or without food.The study drug will be continued as long as the study participant is tolerating the study drug and continues androgen deprivation treatment until confirmed disease progression through imaging.The safety of the study drug will be determined by the frequency of serious adverse events, frequency and severity of adverse events, frequency of study drug discontinuation due to adverse events as well as the frequency of new clinically significant changes in physical examination findings, vital signs, laboratory values and ECGs.The efficacy analyses will be conducted using the intent-to-treat population defined as all randomized participants.The study will be conducted at 225 locations worldwide. About 1,680 people will participate in this study, 10 will be from USC.

Phase

N/A

Inclusion and Exclusion Criteria

  • 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

  • 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

Sites

Please contact Anayansi Miloud to learn more about where you can participate in this trial. Please use the contact form on the right side.

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