Prevalence of HRR-related Genes Mutations and Prognosis in Metastatic Castration Resistant Prostate Cancer (mCRPC) Patients in Real World Setting
ZENSHIN
1 other identifier
observational
205
1 country
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2020
Shorter than P25 for all trials
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2020
CompletedFirst Posted
Study publicly available on registry
June 11, 2020
CompletedStudy Start
First participant enrolled
July 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 18, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 18, 2020
CompletedDecember 7, 2021
November 1, 2021
5 months
May 21, 2020
November 30, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Proportion of each treatment pattern
From index date(diagnosed as mCRPC) patients to December 31 2020
Other Outcomes (2)
Patient's characteristics including stratified by tissue HRR-related gene mutations in mCRPC patients
Baseline
PSA50 response
From index date(diagnosed as mCRPC) to december 31 2020
Eligibility Criteria
The target population is mCRPC patients who diagnosed between 2014 and 2018 and be confirmed to be succeeded HRR-related gene mutation analysis with archived primary or metastatic tumor sample. As median of expected overall survival of mCRPC is 2.5 to 3 years from diagnosis, follow up period is enough to measure outcomes including survival. The baseline period is set to calculate overall survival and to detect clinical outcome at least half. The patients will be enrolled consecutively to this study.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (26)
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
Related Links
Biospecimen
An archived formalin fixed paraffin embedded (FFPE) sample, ten slides and 10 μm in thickness on uncharged slide be used for HRR-related gene mutation testing in principle. And also, ten 10 μm slides is sent to Myriad with one 3-5 micron on a charge slide for the HE staining(Hematoxylin and eosin staining) which is continuous with the slice for HRR-related gene mutation. These contents include with a sample of \>25 mm2 in section area containing a ≥30% tumor nuclei preferred (≥20% tumor nuclei accepted). If patients have some tumor samples at multiple points, the latest sample is preferred to use HRR-related gene mutation testing. And other tumor sample is acceptable to use HRR-related gene mutation testing if test is failed.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2020
First Posted
June 11, 2020
Study Start
July 29, 2020
Primary Completion
December 18, 2020
Study Completion
December 18, 2020
Last Updated
December 7, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved, AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials/studies via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.