metastatic castration resistant prostate cancer (mCRPC)
Conditions
Interventions
None listed
Sponsors
AstraZeneca K.K.
Linical Co.,Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Age > 20, Japanese men at the time of informed consent. 2. Patients who provided informed consent. If the patient has died, opt-out will be applicable. 3. Patients who are diagnosed as mCRPC between January 1st in 2014 and December 31st in 2018. 4. Patients who have a FFPE tumor sample (primary or metastatic) with Formalin Neutral Buffer Solution 5. Patients which the investigator judges to secure the enough amount of tumor samples from future laboratory test
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome is prevalence of tissue HRR-related gene mutations | — |
Secondary
| Measure | Time frame |
|---|---|
| <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 | — |
Countries
Japan
Contacts
Public ContactHitoshi Takuse
Linical Co.,Ltd. Contract Medical Affairs Unit, Clinical Trial Operations
Outcome results
None listed