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)
Metastasis-Free Survival (MFS) by Blinded Independent Central Review (BICR) — Up to approximately 43 Months MFS was defined as the time from randomization to the time of first evidence of BICR-confirmed bone or soft tissue distant metastasis or death due to any cause, whichever occurred first. The MFS data for participants without metastasis or death were performed for US or ex-US regulatory purposes. Radiographic scans (bone scans and computerized tomography \[CT\] or magnetic resonance imaging \[MRI\] of the chest, abdomen, and pelvis) were performed for detection of metastasis throughout the study.
Trial sites (379)
Facility
City
Region
Status
—
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
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.