A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer

Not Recruiting

Trial ID: NCT01946204

Purpose

The purpose of this study is to evaluate the efficacy and safety of apalutamide in adult men with high-risk non-metastatic castration-resistant prostate cancer.

Official Title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men With Non-Metastatic (M0) Castration-Resistant Prostate Cancer

Stanford Investigator(s)

Sandy Srinivas
Sandy Srinivas

Professor of Medicine (Oncology) and, by courtesy, of Urology

Alice C. Fan
Alice C. Fan

Assistant Professor of Medicine (Oncology) and, by courtesy, of Urology

Eligibility


Inclusion Criteria:

   - Histologically or cytologically confirmed adenocarcinoma of the prostate without
   neuroendocrine differentiation or small cell features with high risk for development
   of metastases, defined as prostate-specific antigen doubling time (PSADT) less than or
   equal to (<=) 10 months. PSADT is calculated using at least 3 prostate-specific
   antigen (PSA) values obtained during continuous ADT (androgen deprivation therapy)

   - Castration-resistant prostate cancer demonstrated during continuous ADT, defined as 3
   PSA rises, at least 1 week apart, with the last PSA greater than (>) 2 nanogram per
   milliliter (ng/mL)

   - Maintain castrate levels of testosterone within 4 weeks prior to randomization and
   throughout the study

   - Patients currently receiving bone loss prevention treatment with bone-sparing agents
   must be on stable doses for at least 4 weeks prior to randomization

   - Patients who received a first generation anti-androgen (for example, bicalutamide,
   flutamide, nilutamide) must have at least a 4-week washout prior to randomization AND
   must show continuing disease (PSA) progression (an increase in PSA) after washout

   - At least 4 weeks must have elapsed from the use of 5-alpha reductase inhibitors,
   estrogens, and any other anti-cancer therapy prior to randomization

   - At least 4 weeks must have elapsed from major surgery or radiation therapy prior to
   randomization

   - Eastern Cooperative Oncology Group Performance Status 0 or 1

   - Resolution of all acute toxic effects of prior therapy or surgical procedure to Grade
   <= 1 or baseline prior to randomization

   - Adequate organ function according to protocol-defined criteria

   - Administration of growth factors or blood transfusions will not be allowed within 4
   weeks of the hematology labs required to confirm eligibility

Exclusion Criteria:

   - Presence of confirmed distant metastases, including central nervous system and
   vertebral or meningeal involvement

   - Symptomatic local or regional disease requiring medical intervention

   - Prior treatment with second generation anti-androgens

   - Prior treatment with CYP17 inhibitors

   - Prior treatment with radiopharmaceutical agents, or any other investigational agent
   for non-metastatic castration-resistant prostate cancer

   - Prior chemotherapy for prostate cancer except if administered in the
   adjuvant/neoadjuvant setting

   - History of seizure or condition that may pre-dispose to seizure

   - Concurrent therapy with protocol-defined excluded medications

   - History or evidence of any of the following conditions: any prior malignancy (other
   than adequately treated basal cell or squamous cell skin cancer, superficial bladder
   cancer, or any other cancer in situ currently in complete remission) within 5 years
   prior to randomization; severe/unstable angina, myocardial infarction, symptomatic
   congestive heart failure, arterial or venous thromboembolic events, or clinically
   significant ventricular arrhythmias within 6 months prior to randomization;
   uncontrolled hypertension; gastrointestinal disorder affecting absorption; active
   infection; and, any other condition that, in the opinion of the investigator, would
   impair the patient's ability to comply with study procedures

Intervention(s):

drug: Placebo

drug: Apalutamide

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061

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