Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer (China Cohort)

Sponsor
AstraZeneca
Study ID
NCT05171816
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • olaparib — DRUG
    300 mg (2 x 150 milligrams (mg) tablets) twice daily
  • abiraterone acetate — DRUG
    1000 milligrams (mg) once daily

Study Details

The purpose of this study is to evaluate the efficacy and safety (including evaluating side effects) of combination of olaparib and abiraterone versus placebo and abiraterone in patients with metastatic castration-resistant prostate cancer (mCRPC) who have received no prior cytotoxic chemotherapy or new hormonal agents (NHAs) at metastatic castration-resistant prostate cancer (mCRPC) stage.

Key Dates

Start date
Jun 24, 2021
Status verified
Feb 2026
Primary completion
Jan 22, 2024
Completion
Apr 28, 2026

Study Design

Enrollment
110 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: olaparib plus abiraterone
    Olaparib is available as a film-coated tablet containing 100 milligrams (mg) or 150 milligrams (mg) of olaparib. Subjects will be administered olaparib orally at a dose of 300 milligrams (mg) twice daily (bid). The initial dosage of 300 milligrams (mg) twice daily will be composed of 2 x 150 milligrams (mg) tablets per dose. The 100 milligrams (mg) and 150 milligrams (mg) tablets will be used to manage dose reductions during the study. Abiraterone acetate with prednisone or prednisolone will be sourced locally as commercially available materials. Subjects will be administered abiraterone orally at a dose of 1000 milligrams (mg) once daily, in combination with prednisone or prednisolone 5 milligrams (mg) administered orally twice daily.
  • Placebo Comparator: placebo plus abiraterone
    Placebo to match olaparib is available as a film-coated tablet in 100 milligrams (mg) or 150 milligrams (mg). Subjects will be administered placebo orally at a dose of 300 milligrams (mg) twice daily (bid). The initial dosage of 300 milligrams (mg) twice daily will be composed of 2 x 150 milligrams (mg) tablets per dose. The 100 milligrams (mg) and 150 milligrams (mg) tablets will be used to manage dose reductions during the study. Abiraterone acetate with prednisone or prednisolone will be sourced locally as commercially available materials. Subjects will be administered abiraterone orally at a dose of 1000 milligrams (mg) once daily, in combination with prednisone or prednisolone 5 milligrams (mg) administered orally twice daily.

Primary Outcome Measure

Radiological Progression Free Survival (rPFS) [ Time Frame: Tumour imaging CT/MRI and bone scan were assessed every 8 weeks from randomisation to week 24 and then every 12 weeks until RECIST progression. Patients were followed up for 479 days (approx 16 months) at minimum and 913 days (approx 30 months) at maximum ]

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