| Registry | NCT04425200, acronym ZENSHIN |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 205 (Actual) |
| Sponsor | AstraZeneca (Industry) |
| Conditions | Prostatic Neoplasms |
| Dates | start 2020-07-29, primary completion 2020-12-18, completion 2020-12-18, first posted 2020-06-11, last updated 2021-12-07 |
| Locations | 26 sites in Japan |
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All trials for Prostatic Neoplasms
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.
Sex: Male
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Nagoya City University Hospital | Nagoya, Aichi-ken | Japan | |
| Nagoya University Hospital | Nagoya, Aichi-ken | Japan | |
| Hirosaki University Hospital | Hirosaki, Aomori | Japan | |
| Jikei University Kashiwa Hospital | Kashiwa, Chiba | Japan | |
| Ehime University Hospital | Tōon, Ehime | Japan | |
| National Hospital Organization Kure Medical Center | Kure, Hiroshima | Japan | |
| Hakodate Goryoukaku Hospital | Hakodate, Hokkaido | Japan | |
| Hokkaido University Hospital | Sapporo, Hokkaido | Japan | |
| Sapporo Medical University Hospital | Sapporo, Hokkaido | Japan | |
| Kobe City Medical Center General Hospital | Kobe, Hyōgo | Japan | |
| Kobe University Hospital | Kobe, Hyōgo | Japan | |
| University of Tsukuba Hospital | Tsukuba, Ibaraki | Japan | |
| Kanazawa University Hospital | Kanazawa, Ishikawa-ken | Japan | |
| Kagawa University Hospital | Hiragi, Kagawa-ken | Japan | |
| Yokohama City University Hospital | Yokohama, Kanagawa | Japan | |
| Yokohama City University Medical Center | Yokohama, Kanagawa | Japan | |
| Nara Medical University Hospital | Kashihara, Nara | Japan | |
| Kindai University Hospital | Sayama, Osaka | Japan | |
| Saitama Medical Center | Kawagoe, Saitama | Japan | |
| Tottori University Hospital | Yonago, Tottori | Japan | |
| Yamaguchi University Hospital | Ube, Yamaguchi | Japan | |
| Chiba University Hospital | Chiba | Japan | |
| Gifu University Hospital | Gifu | Japan | |
| Kyoto Prefectural University of Medicine | Kyoto | Japan | |
| University of Miyazaki Hospital | Miyazaki | Japan | |
| Okayama University Hospital | Okayama | Japan |