Prevalence of HRR-related Genes Mutations and Prognosis in Metastatic Castration Resistant Prostate Cancer (mCRPC) Patients in Real World Setting

Plain-language summary

This observational study examined how frequently HRR-related gene mutations occur and their impact on prognosis in patients with metastatic castration-resistant prostate cancer, under real-world conditions. Japanese men over 20 diagnosed between 2014 and 2018 were eligible. It was a non-phase observational study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Completed

Sponsor

AstraZeneca

Start date

7/29/2020

Estimated completion

12/18/2020

Countries

Japan

Related genes

Locations

• Nagoya, Japan
• Nagoya, Japan
• Hirosaki, Japan
• Kashiwa, Japan
• Tōon, Japan
• Kure, Japan
• Hakodate, Japan
• Sapporo, Japan
• Sapporo, Japan
• Kobe, Japan
• Kobe, Japan
• Tsukuba, Japan
• Kanazawa, Japan
• Hiragi, Japan
• Yokohama, Japan
• Yokohama, Japan
• Kashihara, Japan
• Sayama, Japan
• Kawagoe, Japan
• Yonago, Japan
• Ube, Japan
• Chiba, Japan
• Gifu, Japan
• Kyoto, Japan
• Miyazaki, Japan
• Okayama, Japan

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* 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 Criteria:

* 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.