Overview

This trial is active, not recruiting.

Condition prostatic neoplasms
Treatments apalutamide, abiraterone acetate, prednisone, placebo
Phase phase 3
Sponsor Aragon Pharmaceuticals, Inc.
Start date November 2014
End date December 2018
Trial size 983 participants
Trial identifier NCT02257736, 2014-001718-25, 56021927PCR3001, CR105505

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]).

United States California, Colorado, Missouri, New York, and Wisconsin
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Participants will receive 240 milligram (mg) tablet of apalutamide and 1000 mg (four 250 mg tablets) of abiraterone acetate (AA) once daily on an empty stomach and 5 mg prednisone (P), AAP, twice daily, until disease progression, unacceptable toxicity, or end of treatment, whichever occurs first.
apalutamide
Participants will receive 240 milligram (mg) tablet of apalutamide once daily until disease progression, unacceptable toxicity, or end of treatment, whichever occurs first.
abiraterone acetate ZYTIGA
Participants will receive 1000 mg (four 250 mg tablets) of abiraterone acetate (AA) once daily on an empty stomach until disease progression, unacceptable toxicity, or end of treatment, whichever occurs first.
prednisone
Participants will receive 5 mg tablet prednisone twice daily until disease progression, unacceptable toxicity, or end of treatment, whichever occurs first.
(Placebo Comparator)
Participants will receive matching Placebo of apalutamide and 1000 mg (four 250 mg tablets) of abiraterone acetate (AA)once daily on an empty stomach and 5 mg prednisone (P), AAP, twice daily until disease progression, unacceptable toxicity, or end of treatment, whichever occurs first.
abiraterone acetate ZYTIGA
Participants will receive 1000 mg (four 250 mg tablets) of abiraterone acetate (AA) once daily on an empty stomach until disease progression, unacceptable toxicity, or end of treatment, whichever occurs first.
prednisone
Participants will receive 5 mg tablet prednisone twice daily until disease progression, unacceptable toxicity, or end of treatment, whichever occurs first.
placebo
Participants will receive matching placebo to apalutamide once daily until study drug discontinuation.

Primary Outcomes

Measure
Radiographic Progression-free Survival (rPFS).
time frame: Time from randomization until death or lost to follow-up or withdrawal of consent or study termination, whichever occurs first, up to 5 years

Secondary Outcomes

Measure
Overall Survival (OS)
time frame: Time from randomization until death or lost to follow-up or withdrawal of consent or study termination, whichever occurs first, up to 5 years
Time to Chronic Opioid Use
time frame: Baseline up to 5 years
Time to Initiation of Cytotoxic Chemotherapy
time frame: Baseline up to 5 years
Time to Pain Progression
time frame: Baseline up to 5 years

Eligibility Criteria

Male participants at least 18 years old.

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 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)

Additional Information

Official title A Phase 3 Randomized, Placebo-controlled Double-blind Study of JNJ-56021927 in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)
Description This is a randomized (study drug assigned by chance), double-blind (neither the Investigator nor the participant know the treatment) placebo-controlled and multicenter (when more than 1 hospital or medical school team work on a medical research study) study to determine if participants with chemotherapy-naive mCRPC will benefit from the addition of apalutamide to AAP compared with AAP alone. The study consists of 3 phases: Screening phase; Treatment phase, and Follow-up phase. Participants' safety will be monitored throughout the study.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Aragon Pharmaceuticals, Inc..