The Study of Olaparib Combined With Abiraterone and Prednisone in mHSPC Patients With HRR Gene Mutation
Status:
Not yet recruiting
Trial end date:
2024-12-01
Target enrollment:
Participant gender:
Summary
This is a single-center, single-arm, prospective study to assess the efficacy and safety of
Olaparib combined with Abiraterone plus Prednisone in subjects with metastatic hormone
sensitive prostate cancer (mHSPC) who carry deleterious germline or homologous recombination
repair (HRR) mutations.
Olaparib is an oral, highly selective poly (ADP-ribose) polymerase (PARP) inhibitor that
potently inhibits the activity of deoxyribonucleic acid repair polymerases. Abiraterone
acetate (AA) is a prodrug of abiraterone that potently inhibits cytochrome P450c17, a key
enzyme in androgen biosynthesis.
A total of 30 mHSPC subjects with HRR gene mutations that meet the criteria will be included
in the study. Eligible subjects will receive oral Olaparib tablets 300 mg BID, combined with
Abiraterone acetate 1000 mg QD plus Prednisone 5 mg, and the study will end when the primary
endpoint radiographic progression-free survival (rPFS) data maturity reaches 60%. During the
treatment and follow-up periods, all subjects will have regular visits to assess the efficacy
and safety of Olaparib in combination with abiraterone acetate plus prednisone. Radiographic
progression-free survival (rPFS), prostate-specific antigen response (PSA response rate),
prostate-specific antigen progression-free survival (PSA-PFS), radiological objective
response rate (ORR) and other indicators will be assessed and calculated.