Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Pfizer

Collaborator: Medivation, Inc.

Stanford Investigator(s):

Intervention(s):

  • Drug: Enzalutamide
  • Drug: Placebo

Phase:

Phase 3

Eligibility


Randomized, Double Blind Treatment Period:

Inclusion 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

Exclusion Criteria:

   - 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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Male

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061
Not Recruiting