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Active, not recruiting Phase 3

An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)

NCT02257736 · tracked via the Priya Life Science Australia tracker
Phase
Phase 3
Started
2014-11-26
Last updated
2026-09-28

Condition(s) studied

Prostatic Neoplasms

Investigational drug(s) / intervention(s)

Apalutamide →Abiraterone acetate →Prednisone →Placebo

Apalutamide: Participants will receive 240 mg (4\*60 mg tablets) of apalutamide once daily orally.

Abiraterone acetate: Participants will receive 1000 mg (4\*250 mg tablets) of abiraterone acetate (AA) once daily orally.

Prednisone: Participants will receive 5 mg tablet of prednisone twice daily orally.

Placebo: Participants will receive matching placebo to apalutamide once daily orally.

Study summary

The purpose of this study is to compare the radiographic progression-free survival (rPFS) of apalutamide in combination with abiraterone acetate (AA) plus prednisone or prednisolone (AAP) and AAP in participants with chemotherapy-naive (participants who did not receive any chemotherapy \[treatment of cancer using drugs\]) metastatic castration-resistant prostate cancer (mCRPC) (cancer of prostate gland \[gland that makes fluid that aids movement of sperm\]).

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adenocarcinoma of the prostate * Metastatic disease as documented by technetium-99m (99mTc) bone scan or metastatic lesions by computed tomography (CT) or magnetic resonance imaging (MRI) scans (visceral or lymph node disease). If lymph node metastasis is the only evidence of metastasis, it must be greater than or equal to (\>=) 2 centimeter (cm) in the longest diameter * Castration-resistant prostate cancer demonstrated during continuous androgen deprivation therapy (ADT), defined as 3 rises of PSA, at least 1 week apart with the last androgen deprivation therapy (PSA) \>= 2 nanogram per milliliters (ng/mL) * Participants who received a first generation anti-androgen (eg, bicalutamide, flutamide, nilutamide) must have at least a 6-week washout prior to randomization and must show continuing disease (PSA) progression (an increase in PSA) after the washout period * Prostate cancer progression documented by prostate-specific antigen (PSA) according to the Prostate Cancer Clinical Trials Working Group (PCWG2) or radiographic progression of soft tissue according to modified Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST) modified based on PCWG2, or radiographic progression of bone according to PCWG2 * Participants who cross-over from Prednisone alone to open-label apalutamide plus AAP should still be in the double-blind phase of the study, should be receiving AAP alone and should have ECOG 0-1-2. Exclusion Criteria: * Small cell or neuroendocrine carcinoma of the prostate * Known brain metastases * Prior chemotherapy for prostate cancer, except if administered in the adjuvant/neoadjuvant setting * Previously treated with ketoconazole for prostate cancer for greater than 7 days * Therapies that must be discontinued or substituted at least 4 weeks prior to randomization include the following: a) Medications known to lower the seizure threshold, b) Herbal and non-herbal products that may decrease PSA levels (example \[eg\], saw palmetto, pomegranate) or c) Any investigational agent * At Screening need for parenteral or oral opioid analgesics (eg, codeine, dextropropoxyphene)

Primary outcome measure(s)

  • Radiographic Progression-free Survival (rPFS) — Up to 3 years and 4 months
    The rPFS was defined as the time from randomization to the occurrence of one of the following: 1) a participant was considered to have progressed by bone scan if - a) the first bone scan with greater than or equal to (\>=) 2 new lesions compared to baseline was observed in less than (\<) 12 weeks from randomization and was confirmed by a second bone scan taken \>=6 weeks later showing \>=2 additional new lesions (a total of \>=4 new lesions compared to baseline), b) the first bone scan with \>=2 new lesions compared to baseline was observed in \>=12 weeks from randomization and the new lesions were verified on the next bone scan \>=6 weeks later (a total of \>=2 new lesions compared to baseline); 2) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.

Trial sites (173)

FacilityCityRegionStatus
— Phoenix Arizona
— La Mesa California
— Los Angeles California
— Modesto California
— San Diego California
— San Francisco California
— Santa Barbara California
— Aurora Colorado
— Denver Colorado
— Jensen Beach Florida
— Lakeland Florida
— New Port Richey Florida
— Ocala Florida
— Atlanta Georgia
— Melrose Illinois
— Niles Illinois
— Marrero Louisiana
— New Orleans Louisiana
— Shreveport Louisiana
— Auburn Maine
— Baltimore Maryland
— St Louis Missouri
— Omaha Nebraska
— Las Vegas Nevada
— Albany New York
— Johnson City New York
— New York New York
— Poughkeepsie New York
— Syracuse New York
— The Bronx New York
— Columbus Ohio
— Tualatin Oregon
— Lancaster Pennsylvania
— Pittsburgh Pennsylvania
— Charleston South Carolina
— Myrtle Beach South Carolina
— Nashville Tennessee
— Austin Texas
— Houston Texas
— Norfolk Virginia

+ 133 more sites — see the full list on the official registry below.

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 NCT02257736 on ClinicalTrials.gov ↗ ← All trials in Australia