The Study of Olaparib in Newly Diagnosed mCRPC Patients With HRR Gene Mutation
Status:
Recruiting
Trial end date:
2024-04-26
Target enrollment:
Participant gender:
Summary
This is a multi-center, single-arm, prospective study to assess the efficacy and safety of
Olaparib in men with newly diagnosed metastatic castration-resistant prostate cancer (mCRPC)
who carried homologous recombination repair (HRR) gene mutations and have progressed after
treatment with novel endocrine agents (NHA) in the metastatic castration-sensitive prostate
cancer or non-metastatic castration-resistant prostate cancer.
A total of 30 newly diagnosed mCRPC subjects with radiologically evaluable disease at
baseline who have progressed on prior NHA and carry HRR gene mutations that meet the criteria
will be included in the study. Eligible subjects will receive a treatment regimen of oral
Olaparib tablets 300 mg twice daily until disease progression or intolerance. During the
treatment and follow-up periods, all subjects will have regular visits to assess the efficacy
and safety of Olaparib. Data on objective radiographic response (ORR), prostate-specific
antigen response (PSA response), radiographic progression-free survival (rPFS), and time to
prostate-specific antigen progression (TTPP) will be collected during the study.
Phase:
Phase 2
Details
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University