- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04425200
Prevalence of HRR-related Genes Mutations and Prognosis in Metastatic Castration Resistant Prostate Cancer (mCRPC) Patients in Real World Setting (ZENSHIN)
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Chiba, Japan
- Chiba University Hospital
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Gifu, Japan
- Gifu University Hospital
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Kyoto, Japan
- Kyoto Prefectural University of Medicine
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Miyazaki, Japan
- University of Miyazaki Hospital
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Okayama, Japan
- Okayama University Hospital
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Aichi
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Nagoya, Aichi, Japan
- Nagoya University Hospital
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Nagoya, Aichi, Japan
- Nagoya City University Hospital
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Aomori
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Hirosaki, Aomori, Japan
- Hirosaki University Hospital
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Chiba
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Kashiwa, Chiba, Japan
- Jikei University Kashiwa Hospital
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Ehime
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Toon, Ehime, Japan
- Ehime University Hospital
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Hiroshima
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Kure, Hiroshima, Japan
- National Hospital Organization Kure Medical Center
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Hokkaido
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Hakodate, Hokkaido, Japan
- Hakodate Goryoukaku Hospital
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Sapporo, Hokkaido, Japan
- Hokkaido University Hospital
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Sapporo, Hokkaido, Japan
- Sapporo Medical University Hospital
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Hyogo
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Kobe, Hyogo, Japan
- Kobe City Medical Center General Hospital
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Kobe, Hyogo, Japan
- Kobe University Hospital
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Ibaraki
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Tsukuba, Ibaraki, Japan
- University of Tsukuba Hospital
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Ishikawa
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Kanazawa, Ishikawa, Japan
- Kanazawa University Hospital
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Kagawa
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Miki, Kagawa, Japan
- Kagawa University Hospital
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Kanagawa
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Yokohama, Kanagawa, Japan
- Yokohama City University Medical Center
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Yokohama, Kanagawa, Japan
- Yokohama City University Hospital
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Nara
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Kashihara, Nara, Japan
- Nara Medical University Hospital
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Osaka
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Osakasayama, Osaka, Japan
- Kindai University Hospital
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Saitama
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Kawagoe, Saitama, Japan
- Saitama Medical Center
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Tottori
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Yonago, Tottori, Japan
- Tottori University Hospital
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Yamaguchi
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Ube, Yamaguchi, Japan
- Yamaguchi University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of tissue HRR-related gene mutations
Time Frame: Baseline
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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.
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of each treatment pattern
Time Frame: From index date(diagnosed as mCRPC) patients to December 31 2020
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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.
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From index date(diagnosed as mCRPC) patients to December 31 2020
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient's characteristics including stratified by tissue HRR-related gene mutations in mCRPC patients
Time Frame: Baseline
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Patient's characteristics will be summarized.
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Baseline
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PSA50 response
Time Frame: From index date(diagnosed as mCRPC) to december 31 2020
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PSA50 response will be analysed based on baseline and nadir PSA value in each treatment.
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From index date(diagnosed as mCRPC) to december 31 2020
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D081LR00002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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