Prostatic NeoplasmsZENSHINNCT04425200
Prevalence of HRR-related Genes Mutations and Prognosis in Metastatic Castration Resistant Prostate Cancer (mCRPC) Patients in Real World Setting
An observational study of Prostatic Neoplasms, run by AstraZeneca at 26 sites in Japan.
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… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostatic Neoplasms
- How many people
- 205 participants
- Where
- 26 sitesJapan
- Study dates
- 29 Jul 2020to 18 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
Japan26 sites
Chiba University Hospital
Chiba
Gifu University Hospital
Gifu
Hakodate Goryoukaku Hospital
Hakodate, Hokkaido
Kagawa University Hospital
Hiragi, Kagawa-ken
Hirosaki University Hospital
Hirosaki, Aomori
Kanazawa University Hospital
Kanazawa, Ishikawa-ken
Nara Medical University Hospital
Kashihara, Nara
Jikei University Kashiwa Hospital
Kashiwa, Chiba
Saitama Medical Center
Kawagoe, Saitama
Kobe City Medical Center General Hospital
Kobe, Hyōgo
Kobe University Hospital
Kobe, Hyōgo
National Hospital Organization Kure Medical Center
Kure, Hiroshima
Kyoto Prefectural University of Medicine
Kyoto
University of Miyazaki Hospital
Miyazaki
Nagoya City University Hospital
Nagoya, Aichi-ken
Nagoya University Hospital
Nagoya, Aichi-ken
Okayama University Hospital
Okayama
Hokkaido University Hospital
Sapporo, Hokkaido
Sapporo Medical University Hospital
Sapporo, Hokkaido
Kindai University Hospital
Sayama, Osaka
Ehime University Hospital
Tōon, Ehime
University of Tsukuba Hospital
Tsukuba, Ibaraki
Yamaguchi University Hospital
Ube, Yamaguchi
Yokohama City University Hospital
Yokohama, Kanagawa
Yokohama City University Medical Center
Yokohama, Kanagawa
Tottori University Hospital
Yonago, Tottori
About this study
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
Read more
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.
- Conditions
- Prostatic Neoplasms
- Keywords
- metastatic castration resistant prostate cancer, BRCA1, BRCA2, ATM, Homologous recombination repair
- Medical subject headings
- Prostatic Neoplasms, Fanconi Anemia, Complementation Group D1, Hereditary Sensory and Autonomic Neuropathies
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (1)
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.
Measured: From index date(diagnosed as mCRPC) patients to December 31 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start29 Jul 2020
- Primary completion18 Dec 2020
- Study completion18 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04425200
- Sponsor's protocol ID
- D081LR00002
- Acronym
- ZENSHIN
- Status last verified
- Nov 2021
- First submitted
- 21 May 2020
- Last updated
- 7 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of HRR-related Genes Mutations and Prognosis in Metastatic Castration Resistant Prostate Cancer (mCRPC) Patients in Real World Setting
- ClinicalTrials.gov ID
- NCT04425200
- Acronym / sponsor ID
- ZENSHIN / D081LR00002
- Conditions
- Prostatic Neoplasms
- Keywords
- metastatic castration resistant prostate cancer, BRCA1, BRCA2, ATM, Homologous recombination repair
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 29 Jul 2020 (actual)
- Primary completion
- 18 Dec 2020 (actual)
- Study completion
- 18 Dec 2020 (actual)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of tissue HRR-related gene mutations
Time frame: 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.
1 secondary outcome
Proportion of each treatment pattern
Time frame: From index date(diagnosed as mCRPC) patients to December 31 2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2021.
- Redacted CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Neoplasms, run by AstraZeneca at 26 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of tissue HRR-related gene mutations (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2021.