Prevalence of HRR-related genes mutations and prognosis in metastatic castration resistant prostate cancer (mCRPC) patients in real world setting(ZENSHIN Study)
Not Applicable
- Conditions
- metastatic castration resistant prostate cancer (mCRPC)
- Registration Number
- JPRN-UMIN000040511
- Lead Sponsor
- AstraZeneca K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- Male
- Target Recruitment
- 155
Inclusion Criteria
Not provided
Exclusion Criteria
1. Patients who have failed HRR-related gene mutation testing with the myChoice HRD plus in screening period. 2. Patients who have an only FFPE primary tumor sample (primary or metastatic) with unbuffered formalin including acidic formalin. 3. Patients who have taken an investigational medical product for prostate cancer from Jan 1st , 2014 to Dec 31st 2020.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome is prevalence of tissue HRR-related gene mutations
- Secondary Outcome Measures
Name Time Method <Secondary Endpoints> 1.Proportion of each treatment pattern <Exploratory Endpoints> 1.Patient's characteristics including stratified by tissue HRR-related gene mutations in mCRPC patients 2. PSA response50 in 1L, 2L, and 3L 3. PSA-PFS in 1L 4. PSA-PFS in 2L 5. OS from 1L 6. OS by stratified by tissue HRR-related gene mutation status 7. PSA-PFS by stratified by tissue HRR-related gene mutation status in each line treatment 8. OS by stratified by treatment pattern 9. PSA-PFS by stratified by treatment pattern in each line treatment 10. PSA-PFS by treatment pattern, and tissue HRR-related gene mutation status