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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Page 1 of 7 (26 locations)

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