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]).
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.
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)
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
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
Santa Barbara California, , United States
Aurora Colorado, , United States
Denver Colorado, , United States
New Haven Connecticut, , United States
Jensen Beach Florida, , United States
Lakeland Florida, , United States
New Port Richey Florida, , United States
Ocala Florida, , United States
Atlanta Georgia, , United States
Melrose Illinois, , United States
Niles Illinois, , United States
Marrero Louisiana, , United States
New Orleans Louisiana, , United States
Shreveport Louisiana, , United States
Auburn Maine, , United States
Baltimore Maryland, , United States
Boston Massachusetts, , United States
Saint Louis Missouri, , United States
Omaha Nebraska, , United States
Las Vegas Nevada, , United States
Albany New York, , United States
Bronx New York, , United States
Johnson City New York, , United States
New York New York, , United States
Poughkeepsie New York, , United States
Syracuse New York, , United States
Columbus Ohio, , United States
Tualatin Oregon, , United States
Lancaster Pennsylvania, , United States
Pittsburgh Pennsylvania, , United States
Charleston South Carolina, , United States
Myrtle Beach South Carolina, , United States
Nashville Tennessee, , United States
Austin Texas, , United States
Houston Texas, , United States
Norfolk Virginia, , United States
Richmond Virginia, , United States
Auburn Washington, , United States
Seattle Washington, , United States
Spokane Washington, , United States
Wenatchee Washington, , United States
Madison Wisconsin, , United States
Ciudad Automoma Buenos Aires , , Argentina
Ciudad de Buenos Aires , , Argentina
Cordoba , , Argentina
La Rioja , , Argentina
Mendoza , , Argentina
Rosario , , Argentina
Adelaide , , Australia
Ashford , , Australia
Camperdown , , Australia
Herston , , Australia
Liverpool , , Australia
Malvern , , Australia
Melbourne , , Australia
Southport , , Australia
Wahroonga , , Australia
West Heidelberg , , Australia
Woolloongabba , , Australia
Antwerpen , , Belgium
Bruxelles , , Belgium
Gent , , Belgium
Gosselies , , Belgium
Leuven , , Belgium
Liege , , Belgium
Namur , , Belgium
Ottignies , , Belgium
Roeselare , , Belgium
Sint-Niklaas , , Belgium
Barretos , , Brazil
Ijui , , Brazil
Natal , , Brazil
Porto Alegre , , Brazil
Sao Jose do Rio Preto , , Brazil
Sao Paulo , , Brazil
Abbotsford British Columbia, , Canada
Kelowna British Columbia, , Canada
Vancouver British Columbia, , Canada
Halifax Nova Scotia, , Canada
Barrie Ontario, , Canada
London Ontario, , Canada
Oakville Ontario, , Canada
Weston Ontario, , Canada
Montreal Quebec, , Canada
Sherbrooke Quebec, , Canada
Quebec , , Canada
Toronto , , Canada
Angers Cedex 9 , , France
Caen Cedex 05 , , France
Dijon Cedex , , France
Le Mans Cedex 2 , , France
Lyon cedex 03 , , France
Lyon , , France
Montpellier , , France
Paris Cedex 15 , , France
Saint Herblain , , France
Toulouse Cedex 9 , , France
Berlin , , Germany
Dresden , , Germany
Freiburg , , Germany
Hamburg , , Germany
Heidelberg , , Germany
Muenster , , Germany
Nuertingen , , Germany
Wuppertal , , Germany
Fukuoka-shi , , Japan
Kanazawa , , Japan
Kashiwa , , Japan
Kita-Gun , , Japan
Kumamoto , , Japan
Kurume , , Japan
Matsuyama-Shi , , Japan
Miyazaki , , Japan
Nagasaki , , Japan
Osaka-Sayama , , Japan
Osaka , , Japan
Sakura , , Japan
Sapporo , , Japan
Ube , , Japan
Yokohama , , Japan
Goyang-Si , , Korea, Republic of
Seongnam , , Korea, Republic of
Seoul , , Korea, Republic of
Chihuahua , , Mexico
Cuernavaca , , Mexico
Culiacan , , Mexico
Mexico , , Mexico
Oaxaca , , Mexico
Zapopan , , Mexico
Amsterdam Zuidoost , , Netherlands
Amsterdam , , Netherlands
Blaricum , , Netherlands
Den Haag , , Netherlands
Dordrecht , , Netherlands
Groningen , , Netherlands
Heerlen , , Netherlands
Nieuwegein , , Netherlands
Nijmegen , , Netherlands
Rotterdam , , Netherlands
Kursk , , Russian Federation
Moscow , , Russian Federation
Omsk , , Russian Federation
Pyatigorsk , , Russian Federation
Rostov-on-Don , , Russian Federation
Saint Petersburg , , Russian Federation
Saint-Petersburg, , , Russian Federation
Saint-Petersburg , , Russian Federation
Ufa , , Russian Federation
Bloemfontein , , South Africa
Cape Town , , South Africa
Johannesburg , , South Africa
Pretoria , , South Africa
Alcorcon , , Spain
Barcelona , , Spain
Cadiz , , Spain
Cordoba , , Spain
Madrid , , Spain
San Sebastián de los Reyes , , Spain
Valencia , , Spain
Ayr , , United Kingdom
Belfast , , United Kingdom
Birmingham , , United Kingdom
Edinburgh , , United Kingdom
Glasgow , , United Kingdom
London , , United Kingdom
Manchester , , United Kingdom
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?