Status:
COMPLETED
Prevalence of HRR-related Genes Mutations and Prognosis in Metastatic Castration Resistant Prostate Cancer (mCRPC) Patients in Real World Setting
Lead Sponsor:
AstraZeneca
Conditions:
Prostatic Neoplasms
Eligibility:
MALE
Brief Summary
The purpose of this study is to investigate the prevalence of tissue homologous recombination repair (HRR)-related gene mutations (positive/negative/Variant of uncertain significance (VUS)), clinical ...
Eligibility Criteria
Inclusion
- Age \> 20, Japanese men at the time of informed consent.
- Patients who provided informed consent. If the patient has died, opt-out will be applicable.
- Patients who are diagnosed as mCRPC between January 1st in 2014 and December 31st in 2018.
- Patients who have a FFPE tumor sample (primary or metastatic) with Formalin Neutral Buffer Solution.
- Patients which the investigator judges to secure the enough amount of tumor samples for future laboratory test.
Exclusion
- Patients who have failed HRR-related gene mutation testing with the myChoice HRD plus in screening period.
- Patients who have an only FFPE primary tumor sample (primary or metastatic) with unbuffered formalin including acidic formalin.
- Patients who have taken an investigational medical product for prostate cancer from Jan 1st , 2014 to Dec 31st 2020.
Key Trial Info
Start Date :
July 29 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 18 2020
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT04425200
Start Date
July 29 2020
End Date
December 18 2020
Last Update
December 7 2021
Active Locations (26)
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1
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
2
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
3
Hirosaki University Hospital
Hirosaki, Aomori, Japan
4
Jikei University Kashiwa Hospital
Kashiwa, Chiba, Japan