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

Prostatic Neoplasms Clinical Trial

— ZENSHIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04425200
• Other study ID #: D081LR00002
• Status: Completed
• Start date: July 29, 2020
• Est. completion date: December 18, 2020

Study information

• Verified date: November 2021
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: December 18, 2020
• Est. primary completion date: December 18, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

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.

Related Conditions & MeSH terms

• Prostatic Neoplasms

Locations

Country	Name	City	State
Japan	Chiba University Hospital	Chiba
Japan	Gifu University Hospital	Gifu
Japan	Hakodate Goryoukaku Hospital	Hakodate	Hokkaido
Japan	Hirosaki University Hospital	Hirosaki	Aomori
Japan	Kanazawa University Hospital	Kanazawa	Ishikawa
Japan	Nara Medical University Hospital	Kashihara	Nara
Japan	Jikei University Kashiwa Hospital	Kashiwa	Chiba
Japan	Saitama Medical Center	Kawagoe	Saitama
Japan	Kobe City Medical Center General Hospital	Kobe	Hyogo
Japan	Kobe University Hospital	Kobe	Hyogo
Japan	National Hospital Organization Kure Medical Center	Kure	Hiroshima
Japan	Kyoto Prefectural University of Medicine	Kyoto
Japan	Kagawa University Hospital	Miki	Kagawa
Japan	University of Miyazaki Hospital	Miyazaki
Japan	Nagoya City University Hospital	Nagoya	Aichi
Japan	Nagoya University Hospital	Nagoya	Aichi
Japan	Okayama University Hospital	Okayama
Japan	Kindai University Hospital	Osakasayama	Osaka
Japan	Hokkaido University Hospital	Sapporo	Hokkaido
Japan	Sapporo Medical University Hospital	Sapporo	Hokkaido
Japan	Ehime University Hospital	Toon	Ehime
Japan	University of Tsukuba Hospital	Tsukuba	Ibaraki
Japan	Yamaguchi University Hospital	Ube	Yamaguchi
Japan	Yokohama City University Hospital	Yokohama	Kanagawa
Japan	Yokohama City University Medical Center	Yokohama	Kanagawa
Japan	Tottori University Hospital	Yonago	Tottori

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient's characteristics including stratified by tissue HRR-related gene mutations in mCRPC patients	Patient's characteristics will be summarized.	Baseline
Other	PSA50 response	PSA50 response will be analysed based on baseline and nadir PSA value in each treatment.	From index date(diagnosed as mCRPC) to december 31 2020
Primary	Prevalence of tissue HRR-related gene mutations	Calculate number and prevalence of each HRR-related gene mutation status (Positive/Negative/VUS), respectively. Prevalence will be accompanied by 95% Clopper-Pearson confidence intervals.	Baseline
Secondary	Proportion of each treatment pattern	The number (%) of patients by treatment pattern in 1st line treatment, 2nd line, and 3rd line treatment after diagnosed as mCRPC, respectively, will be calculated.	From index date(diagnosed as mCRPC) patients to December 31 2020

External Links

•   Redacted CSR Synopsis