Prevalence of HRR-related Genes Mutations and Prognosis in Metastatic Castration Resistant Prostate Cancer (mCRPC) Patients in Real World Setting
- Conditions
- Prostatic Neoplasms
- Registration Number
- NCT04425200
- Lead Sponsor
- AstraZeneca
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 205
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prevalence of tissue HRR-related gene mutations Baseline 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.
- Secondary Outcome Measures
Name Time Method Proportion of each treatment pattern From index date(diagnosed as mCRPC) patients to December 31 2020 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.
Trial Locations
- Locations (26)
National Hospital Organization Kure Medical Center
🇯🇵Kure, Hiroshima, Japan
Hakodate Goryoukaku Hospital
🇯🇵Hakodate, Hokkaido, Japan
Kanazawa University Hospital
🇯🇵Kanazawa, Ishikawa, Japan
Kagawa University Hospital
🇯🇵Miki, Kagawa, Japan
Chiba University Hospital
🇯🇵Chiba, Japan
Nagoya City University Hospital
🇯🇵Nagoya, Aichi, Japan
Nagoya University Hospital
🇯🇵Nagoya, Aichi, Japan
Hirosaki University Hospital
🇯🇵Hirosaki, Aomori, Japan
Jikei University Kashiwa Hospital
🇯🇵Kashiwa, Chiba, Japan
Tottori University Hospital
🇯🇵Yonago, Tottori, Japan
Yamaguchi University Hospital
🇯🇵Ube, Yamaguchi, Japan
Ehime University Hospital
🇯🇵Toon, Ehime, Japan
Hokkaido University Hospital
🇯🇵Sapporo, Hokkaido, Japan
Sapporo Medical University Hospital
🇯🇵Sapporo, Hokkaido, Japan
Yokohama City University Hospital
🇯🇵Yokohama, Kanagawa, Japan
Kobe City Medical Center General Hospital
🇯🇵Kobe, Hyogo, Japan
Kobe University Hospital
🇯🇵Kobe, Hyogo, Japan
University of Tsukuba Hospital
🇯🇵Tsukuba, Ibaraki, Japan
Saitama Medical Center
🇯🇵Kawagoe, Saitama, Japan
Gifu University Hospital
🇯🇵Gifu, Japan
Yokohama City University Medical Center
🇯🇵Yokohama, Kanagawa, Japan
Nara Medical University Hospital
🇯🇵Kashihara, Nara, Japan
Kindai University Hospital
🇯🇵Osakasayama, Osaka, Japan
University of Miyazaki Hospital
🇯🇵Miyazaki, Japan
Kyoto Prefectural University of Medicine
🇯🇵Kyoto, Japan
Okayama University Hospital
🇯🇵Okayama, Japan