Prostate Neoplasms | 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)
Prostate Neoplasms research study
What is the primary objective of this study?
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 and low-dose prednisone to androgen deprivation therapy (ADT; lutenizing hormone releasing hormone [LHRH] agonists or surgical castration).
Who is eligible to participate?
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)
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Abiraterone acetateAbiraterone acetate tablets will be administered orally at a total dose of 1000 mg per day until disease progression, withdrawal of consent or unacceptable toxicity.
Drug:PrednisonePrednisone 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.
Drug:Abiraterone acetate PlaceboPlacebo matched to abiraterone acetate will be administered orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.
Drug:Prednisone PlaceboPlacebo matched to prednisone will be administered orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Abiraterone acetate + Prednisone + ADTParticipants will receive abiraterone acetate tablet at a total dose of 1000 milligram (mg) along with 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.
Placebo + Androgen Deprivation Therapy (ADT)Participants will receive placebo matched to abiraterone acetate and prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT will be administered.
Active, not recruiting
Start Date: February 12, 2013
Completed Date: December 31, 2022
Phase: Phase 3
Primary Outcome: Radiographic Progression-Free Survival (PFS)
Secondary Outcome: Time to Initiation of Chemotherapy
Study sponsors, principal investigator, and references