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Clinical Trials in Denmark / NCT01946204
Active, not recruiting Phase 3

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

NCT01946204 · tracked via the Priya Life Science Denmark tracker
Phase
Phase 3
Started
2013-10-14
Last updated
2026-08-31

Condition(s) studied

Prostatic Neoplasms

Investigational drug(s) / intervention(s)

Apalutamide →Placebo

Apalutamide: 240 mg tablets administered by mouth on a continuous once daily dosing regimen

Placebo: Matched placebo tablets administered by mouth on a continuous once daily dosing regimen

Study summary

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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (379)

FacilityCityRegionStatus
— Birmingham Alabama
— Anchorage Alaska
— Chandler Arizona
— Tucson Arizona
— Duarte California
— Fullerton California
— Laguna Woods California
— Los Angeles California
— Orange California
— Roseville California
— Sacramento California
— San Bernardino California
— San Diego California
— San Francisco California
— Santa Monica California
— Sherman Oaks California
— Stanford California
— Tarzana California
— Torrance California
— Denver Colorado
— Englewood Colorado
— Glenwood Springs Colorado
— Grand Junction Colorado
— Washington D.C. District of Columbia
— Aventura Florida
— Boca Raton Florida
— Bradenton Florida
— Daytona Beach Florida
— Fort Myers Florida
— Hialeah Florida
— Jacksonville Florida
— Miami Florida
— New Port Richey Florida
— Orlando Florida
— Sarasota Florida
— St. Petersburg Florida
— Wellington Florida
— Meridian Idaho
— Chicago Illinois
— Decatur Illinois

+ 339 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01946204 on ClinicalTrials.gov ↗ ← All trials in Denmark