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