A Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Participants With High-Risk, Metastatic Hormone-Naive Prostate Cancer (mHNPC)

January 31, 2025 updated by: Janssen Research & Development, LLC

A Randomized, Double-blind, Comparative Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Subjects With High-Risk, Metastatic Hormone-naive Prostate Cancer (mHNPC)

The purpose of this study is to determine if newly diagnosed (within previous 3 months) participants with metastatic (spread of cancer cells from one part of the body to another ) hormone-naive prostate cancer (mHNPC) who have high-risk prognostic factors will benefit from the addition of abiraterone acetate plus low-dose prednisone to androgen deprivation therapy (ADT; lutenizing hormone releasing hormone [LHRH] agonists or surgical castration).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized (the treatment group is assigned by chance), double-blind (neither physician nor participant knows the treatment that the participant receives), placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial)-controlled study designed to determine the efficacy of abiraterone acetate plus low-dose prednisone in participants with mHNPC. The study consists of 4 parts: Screening Phase (that is, 28 days before study commences on Day 1); Double-blind treatment Phase (consists of 4-week dosing cycles wherein abiraterone acetate will be administered as 1,000 milligram [mg] plus 5 mg prednisone or only placebo orally); Follow-up Phase (every 4 months up to 60 months or until death, lost to follow up, withdrawal of consent or study termination) Open-label Extension (OLE) Phase. Participants in the Double-blind Treatment Phase will have the opportunity to enroll into the OLE Phase. The OLE Phase will allow participants to receive active drug (abiraterone acetate plus prednisone) until Long-term Extension (LTE) Phase for an additional period of up to 3 years. Participants will discontinue study treatment at disease progression or unacceptable toxicity unless, in the Investigator's opinion, it is deemed that the participants will continue to derive benefit from study treatment. Participants will be randomized in a 1:1 ratio to the active treatment group (abiraterone acetate 1000 mg daily plus prednisone 5 mg daily plus ADT) or the control group (ADT plus placebos).Efficacy will be evaluated primarily by overall survival and radiographic progression-free survival. Participants' safety will be monitored throughout the study.

Study Type

Interventional

Enrollment (Actual)

1209

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
      • Caba, Argentina
      • Cordoba, Argentina
      • La Rioja, Argentina
      • Rosario, Argentina
  • Australia
      • Adelaide, Australia
      • Footscray, Australia
      • Liverpool, Australia
      • Malvern, Australia
      • Randwick, Australia
      • Wahroonga, Australia
  • Belgium
      • Antwerpen, Belgium
      • Bonheiden, Belgium
      • Brasschaat, Belgium
      • Bruxelles, Belgium
      • Charleroi, Belgium
      • Liège, Belgium
      • Namur, Belgium
      • Ottignies, Belgium
      • Sint-Niklaas, Belgium
      • Yvoir, Belgium
  • Brazil
      • Barretos, Brazil
      • Belo Horizonte, Brazil
      • Caxias Do Sul, Brazil
      • Curitiba, Brazil
      • Ijui, Brazil
      • Jau, Brazil
      • Natal, Brazil
      • Novo Hamburgo, Brazil
      • Porto Alegre, Brazil
      • Ribeirao Preto, Brazil
      • Rio de Janeiro, Brazil
      • Salvador, Brazil
      • Sao Jose Do Rio Preto, Brazil
      • Sao Paulo, Brazil
  • Bulgaria
      • Gabrovo, Bulgaria
      • Sofia, Bulgaria
  • Canada
      • Quebec, Canada
    • Alberta
      • Edmonton, Alberta, Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada
    • Ontario
      • Hamilton, Ontario, Canada
      • Kingston, Ontario, Canada
      • Oshawa, Ontario, Canada
      • Ottawa, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
  • Chile
      • Santiago, Chile
  • China
      • Beijing, China
      • Chengdu, China
      • Chongqing, China
      • Guangzhou, China
      • Hangzhou, China
      • Nanjing, China
      • Shanghai, China
      • Su Zhou, China
      • Tianjin, China
      • Wuhan, China
  • Colombia
      • Bogota, Colombia
      • Floridablanca, Colombia
      • Medellin, Colombia
  • Czechia
      • Hradec Kralove, Czechia
      • Olomouc, Czechia
      • Plzen, Czechia
      • Praha 10, Czechia
      • Praha 2, Czechia
      • Praha 4, Czechia
  • Denmark
      • Aarhus N., Denmark
      • Holsterbro, Denmark
      • Odense N/a, Denmark
      • Roskilde, Denmark
      • Vejle, Denmark
  • Finland
      • Oulu, Finland
      • Tampere, Finland
  • France
      • La Chaussee St Victor, France
      • Lille, France
      • Montpellier, France
      • Paris Cedex 14, France
      • Suresnes, France
      • Toulouse, France
      • Villejuif Cedex, France
  • Germany
      • Düsseldorf, Germany
      • Hamburg, Germany
      • Nürtingen, Germany
  • Hungary
      • Budapest, Hungary
      • Budapest N/a, Hungary
      • Győr, Hungary
      • Miskolc, Hungary
      • Pecs, Hungary
      • Szentes, Hungary
  • Israel
      • Beer Yaakov, Israel
      • Beer-Sheva, Israel
      • Haifa, Israel
      • Jerusalem, Israel
      • Kfar Saba, Israel
      • Petah-Tikva, Israel
      • Ramat Gan, Israel
  • Japan
      • Chiba, Japan
      • Gifu, Japan
      • Kashiwa, Japan
      • Matsuyama, Japan
      • Nankoku, Japan
      • Osaka-Sayama, Japan
      • Sakura, Japan
      • Tokushima, Japan
      • Tokyo, Japan
      • Ube, Japan
      • Yokohama, Japan
      • Yufu, Japan
  • Korea, Republic of
      • Bucheon-Si, Korea, Republic of
      • Busan, Korea, Republic of
      • Daegu, Korea, Republic of
      • Daejeon, Korea, Republic of
      • Gyeonggi-do, Korea, Republic of
      • Seoul, Korea, Republic of
  • Malaysia
      • Kuala Lumpur, Malaysia
      • Kuching, Malaysia
  • Mexico
      • Chihuahua, Mexico
      • Cuernavaca, Mexico
      • Durango, Mexico
      • Guadalajara, Mexico
      • Monterrey, Mexico
      • Oaxaca, Mexico
      • Pachuca de Soto, Mexico
      • Zapopan, Mexico
  • Netherlands
      • Alkmaar, Netherlands
      • Amsterdam, Netherlands
      • Amsterdam Zuidoost, Netherlands
      • Hilversum, Netherlands
      • Hoofddorp, Netherlands
      • Nieuwegein, Netherlands
      • Rotterdam, Netherlands
  • New Zealand
      • Auckland, New Zealand
      • Christchurch, New Zealand
      • Hamilton, New Zealand
      • Tauranga, New Zealand
  • Poland
      • Bydgoszcz, Poland
      • Gdansk, Poland
      • Lodz, Poland
      • Lublin, Poland
      • Warszawa, Poland
  • Portugal
      • Braga, Portugal
      • Coimbra, Portugal
      • Lisboa, Portugal
      • Porto, Portugal
  • Romania
      • Brasov, Romania
      • Bucharest, Romania
      • Bucuresti, Romania
      • Cluj Napoca, Romania
      • Iasi, Romania
  • Russian Federation
      • Chelyabinsk, Russian Federation
      • Ekaterinburg, Russian Federation
      • Ivanovo, Russian Federation
      • Izhevsk, Russian Federation
      • Moscow, Russian Federation
      • Nizhny Novgorod, Russian Federation
      • Obninsk, Russian Federation
      • Omsk, Russian Federation
      • Orenburg, Russian Federation
      • Pyatigorsk, Russian Federation
      • Rostov-on-Don, Russian Federation
      • Ryazan, Russian Federation
      • Sankt-Peterburg, Russian Federation
      • Saransk, Russian Federation
      • Saratov, Russian Federation
      • Sochi, Russian Federation
      • St.-Petersburg, Russian Federation
      • Stavropol, Russian Federation
      • Tumen, Russian Federation
      • Ufa, Russian Federation
      • Volgograd, Russian Federation
      • Yoshkar-Ola, Russian Federation
  • Slovakia
      • Košice-Šaca, Slovakia
      • Martin, Slovakia
      • Piestany, Slovakia
      • Prešov, Slovakia
      • Rimavska Sobota, Slovakia
      • Trnava, Slovakia
  • South Africa
      • George, South Africa
      • Port Elizabeth, South Africa
      • Pretoria, South Africa
      • Vosloorus, South Africa
  • Spain
      • Barcelona, Spain
      • Cordoba, Spain
      • Coruña, Spain
      • Madrid, Spain
      • Madrid N/a, Spain
      • Murcia N/a, Spain
  • Sweden
      • Göteborg, Sweden
      • Malmö, Sweden
      • Stockholm, Sweden
      • Umeå, Sweden
      • Uppsala, Sweden
  • Turkey
      • Adana, Turkey
      • Ankara, Turkey
      • Istanbul, Turkey
      • Izmir, Turkey
      • Zonguldak, Turkey
  • Ukraine
      • Cherkassy, Ukraine
      • Dnepropetrovsk, Ukraine
      • Dnipro, Ukraine
      • Khakhiv, Ukraine
      • Kharkiv, Ukraine
      • Kyiv, Ukraine
      • Lviv, Ukraine
      • Makiivka, Ukraine
      • Odessa, Ukraine
      • Uzhgorod, Ukraine
      • Zaporizhzhia, Ukraine
  • United Kingdom
      • Cambridge, United Kingdom
      • Glasgow, United Kingdom
      • Manchester, United Kingdom
      • Nottingham, United Kingdom
      • Oxford, United Kingdom
      • Plymouth, United Kingdom

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Newly diagnosed metastatic prostate cancer within 3 months prior to randomization with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
  • Distant metastatic disease documented by positive bone scan or metastatic lesions on computed tomography (CT) or magnetic resonance imaging (MRI) scan
  • At least 2 of the following high-risk prognostic factors: Gleason score of greater than or equal to (>=8); presence of 3 or more lesions on bone scan; presence of measurable visceral (excluding lymph node disease) metastasis on CT or MRI Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 scan
  • Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1 or 2
  • Adequate hematologic, hepatic, and renal function
  • Agrees to protocol-defined use of effective contraception

Exclusion Criteria:

  • Active infection or other medical condition that would make prednisone use contraindicated
  • Any chronic medical condition requiring a higher systemic dose of corticosteroid than 5 mg prednisone per day
  • Pathological finding consistent with small cell carcinoma of the prostate
  • Known brain metastasis
  • Any prior pharmacotherapy, radiation therapy, or surgery for metastatic prostate cancer (the following exception are permitted): up to 3 months of androgen deprivation therapy (ADT) with lutenizing hormone releasing hormone agonists or antagonists or orchiectomy with or without concurrent anti-androgens prior Cycle 1 Day 1; participants may have one course of palliative radiation or surgical therapy to treat symptoms resulting from metastatic disease if it was administered at least 28 days prior to Cycle 1 Day 1)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Abiraterone acetate + Prednisone + ADT
Participants will receive abiraterone acetate tablet at a total dose of 1000 milligram (mg) plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) will be administered.
Drug: Abiraterone acetate
Abiraterone acetate tablets will be administered orally at a total dose of 1000 mg per day until disease progression, withdrawal of consent or unacceptable toxicity.
Other Names:
  • Zytiga
Drug: Prednisone
Prednisone 5 mg capsule will be administered orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.
Other: Androgen deprivation therapy (ADT)
All participants will receive stable regimen of ADT, that is, lutenizing hormone releasing hormone (LHRH) agonists or surgical castration according to local guidelines until disease progression, withdrawal of consent or unacceptable toxicity.
Placebo Comparator: Placebo + Androgen Deprivation Therapy (ADT)
Participants will receive placebo matched to abiraterone acetate plus prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT will be administered.
Other: Androgen deprivation therapy (ADT)
All participants will receive stable regimen of ADT, that is, lutenizing hormone releasing hormone (LHRH) agonists or surgical castration according to local guidelines until disease progression, withdrawal of consent or unacceptable toxicity.
Drug: Abiraterone acetate Placebo
Placebo matched to abiraterone acetate will be administered orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.
Drug: Prednisone Placebo
Placebo matched to prednisone will be administered orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic Progression-Free Survival (PFS)
Time Frame: Up to 44 months
Radiographic PFS was defined as the time (in months) interval from randomization to the first date of radiographic progression or death. Radiographic progression included progression by bone scan (according to modified Prostate Cancer Working Group 2 [PCWG2] criteria), defined as at least 2 new lesions on bone scan and progression of soft tissue lesions by computed tomography (CT) or magnetic resonance imaging (MRI) (according to Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 criteria). As per the RECIST 1.1 guideline, progression requires a 20 percent (%) increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 millimeter (mm) in the sum as compared to nadir sum of diameter.
Up to 44 months
Overall Survival (OS)
Time Frame: Up to 66 months
Overall survival was defined as the time from randomization to date of death from any cause.
Up to 66 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Initiation of Chemotherapy
Time Frame: Up to 66 months
Time to initiation of chemotherapy was defined as the time (in months) interval from the date of randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer.
Up to 66 months
Time to Subsequent Therapy for Prostate Cancer
Time Frame: Up to 66 months
Time to subsequent therapy was defined as the time (in months) interval from the date of randomization to the date of initiation of subsequent therapy for prostate cancer.
Up to 66 months
Time to Pain Progression
Time Frame: Up to 66 months
Time to pain progression was defined as the time (in months) interval from randomization to the first date a participant experienced a greater than or equal to (>=) 30 percent (%) increase in Brief Pain Inventory-Short Form (BPI-SF) from baseline in the BPI-SF worst pain intensity (Item 3) observed at 2 consecutive evaluations (>=4) weeks apart. BPI-SF was an 11-item questionnaire, designed to assess severity and impact of pain on daily functions. Total score ranged from 0 to 10 with 0 representing "no pain" and 10 representing" pain as bad as you can imagine.
Up to 66 months
Time to Skeletal-Related Event
Time Frame: Up to 66 months
Time to skeletal-related event was defined as the earliest of the following: clinical or pathological fracture, spinal cord compression, palliative radiation to bone, or surgery to bone.
Up to 66 months
Time to Prostate-Specific Antigen (PSA) Progression
Time Frame: Up to 66 months
Time to PSA progression was defined as the time (in months) interval from the date of randomization to the date of PSA progression, according to PCWG2 criteria. PCWG2 defines PSA progression as the date that a 25 percent (%) or greater increase and an absolute increase of 2 nanogram per milliliter (ng/mL) or more from the nadir is documented, which is confirmed by a second value obtained 3 or more weeks later.
Up to 66 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Investigators

  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2013

Primary Completion (Actual)

October 31, 2016

Study Completion (Actual)

February 13, 2022

Study Registration Dates

First Submitted

October 24, 2012

First Submitted That Met QC Criteria

October 24, 2012

First Posted (Estimated)

October 26, 2012

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 31, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR100900
  • 212082PCR3011 (Other Identifier: Janssen Research & Development, LLC)
  • 2012-002940-26 (EudraCT Number)
  • U1111-1135-7146 (Other Identifier: Universal Trial Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Neoplasms

Clinical Trials on Abiraterone acetate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Greece

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe