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Clinical Trials in the UK / 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 UK tracker
Sponsor
Aragon Pharmaceuticals, Inc.
Phase
Phase 3
Started
2013-10-14
Last updated
2026-08-31

Condition(s) studied

Prostatic Neoplasms

Investigational drug(s) / intervention(s)

ApalutamidePlacebo

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.

More Aragon Pharmaceuticals, Inc. trials in the UK

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 the UK