Prostate Cancer Clinical Trial

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)

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]).

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Full 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. At the final analysis, the study will be unblinded. After the Independent Data Monitoring Committee (IDMC) review and the sponsor's subsequent decision participants will be offered to receive treatment either in the Open-Label Extension Phase or the Long-Term Extension Phase of study. Participants' safety will be monitored throughout the study.

View Eligibility Criteria

Eligibility Criteria

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)

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

982

Study ID:

NCT02257736

Recruitment Status:

Active, not recruiting

Sponsor:

Aragon Pharmaceuticals, Inc.

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Phoenix Arizona, , United States

La Mesa California, , United States

Los Angeles California, , United States

Modesto California, , United States

San Diego California, , United States

San Francisco California, , United States

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Mendoza , , Argentina

Rosario , , Argentina

Adelaide , , Australia

Ashford , , Australia

Camperdown , , Australia

Herston , , Australia

Liverpool , , Australia

Malvern , , Australia

Melbourne , , Australia

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Woolloongabba , , Australia

Antwerpen , , Belgium

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Gent , , Belgium

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Leuven , , Belgium

Liege , , Belgium

Namur , , Belgium

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Osaka , , Japan

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Zapopan , , Mexico

Amsterdam Zuidoost , , Netherlands

Amsterdam , , Netherlands

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Den Haag , , Netherlands

Dordrecht , , Netherlands

Groningen , , Netherlands

Heerlen , , Netherlands

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Nijmegen , , Netherlands

Rotterdam , , Netherlands

Kursk , , Russian Federation

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Saint-Petersburg , , Russian Federation

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Alcorcon , , Spain

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Madrid , , Spain

San Sebastián de los Reyes , , Spain

Valencia , , Spain

Ayr , , United Kingdom

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Plymouth , , United Kingdom

Preston , , United Kingdom

Stevenage , , United Kingdom

Sutton , , United Kingdom

Westcliff on Sea , , United Kingdom

Wirral , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

982

Study ID:

NCT02257736

Recruitment Status:

Active, not recruiting

Sponsor:


Aragon Pharmaceuticals, Inc.

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