Study StatusEnrolling
SponsorMedivation Inc. (Prosper)
Study Description

A Phase 3 Randomized, Placebo-controlled Double-blind Study of Enzalutamide (formerly MDV3100)  versus placebo in subjects with Non-Metastatic Castration-resistant Prostate Cancer (CRPC)

Primary Endpoint

Determine the efficacy  of enzalutamide compared with placebo as assessed by metastasis-free survival (MFS)

Inclusion Criteria

-Subject must be a man age ≥ 18 years of age
-Adenocarcinoma of the prostate confirmed histologically or cytologically
-Ongoing androgen deprivation therapy (ADT) with a GnRH agonist/antagonist or prior bilateral orchiectomy (medical or surgical castration)
-Testosterone ≤50ng/dl at screening
-Patients receiving bisphosphonates or denosumab, dose must be stable for at least 4 weeks before randomization
-Progressive disease on ADT at enrollment defined as a minimum of 3 rising PSA values assessed by a local lab at least one week between each determination.
-Most recent local PSA and screening PSA should be ≥2µg/L (2ng/ml) obtained at least 4 weeks after the last dose of androgen receptor inhibitor if applicable.
-PSA doubling time ≤10 months
-ECOG PS grade of 0 or 1
-No prior or present evidence of metastatic disease as assessed by CT/MRI for soft tissue disease and whole-body radionuclide bone scan for bone disease
-Asymptomatic prostate cancer
-Life expectancy ≥12 months
-Agrees to use a condom if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant. Must also agree not to donate sperm during the study

Exclusion Criteria

-Small cell or neuroendocrine carcinoma of the prostate
-Known brain metastases
-Prior chemotherapy ,aminoglutethimide, ketoconazole, abiraterone acitate or enzalutamide for prostate cancer or participation in a clinical trial of an investigational agent that inhibits the androgen receptor or androgen synthesis
-Use of an investigational agent within 4 weeks of randomization.
-History of another invasive cancer within 3 years of randomization
-Ab Neut count <1000µl, Plt count <100,000µl, HGB<10 g/dl, TBili ≥1.5 times upper limit of normal (ULN), ALT or AST ≥2.5 times ULN, Creat >2 mg/dl,Alb <3.0 g/dl
-Clinically significant cardiovascular disease including: MI-6 months before screening, Uncontrolled angina- 3 months before screening, CHF, clinically significant ventricular arrhythmias, Hypotension systolic BP <86 mmHg,
-Bradycardia HR <45 bpm on ECG
-Uncontrolled HTN >170/>105 mmHG
-GI disorder affecting absorption
-Major surgery within 4 weeks of randomization
- Hypersensitivity reaction to the active pharmaceutical ingredient of any capsule components, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene

Side Effects

-Weakness, fatigue, back pain, decreased appetite, constipation, joint pain, diarrhea, hot flashes, upper respiratory tract infection, swelling in hands, arms, legs or feet, shortness of breath, muscle/bone pain, weight loss, headache, high blood pressure, dizziness or vertigo

Interested in enrolling in this trial? Please call 717-431-2285.

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