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

AstraZeneca

Status: Completed

Conditions: Prostatic Neoplasms

Study type: Observational

Funder types: Industry

Identifiers

NCT04425200

D081LR00002

Details and patient eligibility

About

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 outcome such as prostate-specific antigen-progression free survival (PSA-PFS), overall survivals (OS) and treatment pattern in mCRPC patients.

<Methods> Study design: multi-center, prospective cohort study

Data Source(s):

In this study, 155 patients (expected recruitment patients: maximum 205 patients) will be enrolled from approximately 20~30 sites in Japan. Study Population: mCRPC patients who diagnosed between 2014 and 2018. Exposure(s): N.A Outcome(s): Prevalence of tissue HRR-related gene mutations, clinical outcomes such as Over survival and PSA-PFS, Treatment pattern

Sample Size Estimations:

The target population is 155 patients based on the prevalence of HRR-related genes (BRCA1, BRCA2 and ATM) which is reported in previous global study (PROfound study).

Statistical Analysis:

This study is not intended to verify specific hypotheses, and the results are evaluated descriptively. There is no plan of interim analyses before the final analysis.

Enrollment: 205 patients

Sex: Male

Volunteers: No Healthy Volunteers

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.