UMIN-CTR Clinical Trial

Basic information
Public title	Prevalence of HRR-related genes mutations and prognosis in metastatic castration resistant prostate cancer (mCRPC) patients in real world setting(ZENSHIN Study)
Acronym	Prevalence of HRR-related genes mutations and prognosis in metastatic castration resistant prostate cancer (mCRPC) patients in real world setting(ZENSHIN Study)
Scientific Title	Prevalence of HRR-related genes mutations and prognosis in metastatic castration resistant prostate cancer (mCRPC) patients in real world setting(ZENSHIN Study)
Scientific Title:Acronym	Prevalence of HRR-related genes mutations and prognosis in metastatic castration resistant prostate cancer (mCRPC) patients in real world setting(ZENSHIN Study)
Region	Japan

Condition
Condition	metastatic castration resistant prostate cancer (mCRPC)
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To investigate the prevalence of tissue HRR-related gene mutation positive/negative/VUSin mCRPC patients
Basic objectives2	Others
Basic objectives -Others	<Secondary objectives> 1.To assess the treatment pattern (1L, 2L and 3L after diagnosed as mCRPC) <Exploratory Objectives> 1.To investigate the patient's characteristics stratified by tissue HRR-related gene mutations in mCRPC patients 2.To evaluate clinical outcome in mCRPC patients
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Primary outcome is prevalence of tissue HRR-related gene mutations
Key secondary outcomes	<Secondary Endpoints> 1.Proportion of each treatment pattern <Exploratory Endpoints> 1.Patient's characteristics including stratified by tissue HRR-related gene mutations in mCRPC patients 2. PSA response50 in 1L, 2L, and 3L 3. PSA-PFS in 1L 4. PSA-PFS in 2L 5. OS from 1L 6. OS by stratified by tissue HRR-related gene mutation status 7. PSA-PFS by stratified by tissue HRR-related gene mutation status in each line treatment 8. OS by stratified by treatment pattern 9. PSA-PFS by stratified by treatment pattern in each line treatment 10. PSA-PFS by treatment pattern, and tissue HRR-related gene mutation status

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	1. Age > 20, Japanese men at the time of informed consent. 2. Patients who provided informed consent. If the patient has died, opt-out will be applicable. 3. Patients who are diagnosed as mCRPC between January 1st in 2014 and December 31st in 2018. 4. Patients who have a FFPE tumor sample (primary or metastatic) with Formalin Neutral Buffer Solution 5. Patients which the investigator judges to secure the enough amount of tumor samples from future laboratory test
Key exclusion criteria	1. Patients who have failed HRR-related gene mutation testing with the myChoice HRD plus in screening period. 2. Patients who have an only FFPE primary tumor sample (primary or metastatic) with unbuffered formalin including acidic formalin. 3. Patients who have taken an investigational medical product for prostate cancer from Jan 1st , 2014 to Dec 31st 2020.
Target sample size	155

Research contact person
Name of lead principal investigator	1st name Masahisa Middle name Last name Jinushi
Organization	AstraZeneca K.K.
Division name	Medical, Oncology
Zip code	530-0011
Address	Grand Front Osaka Tower B 3-1, Ofuka-cho, Kita-ku, Osaka 530-0011
TEL	06-7711-3560
Email	Masahisa.jinushi@astrazeneca.com

Public contact
Name of contact person	1st name Hitoshi Middle name Last name Takuse
Organization	Linical Co.,Ltd.
Division name	Contract Medical Affairs Unit, Clinical Trial Operations
Zip code	532-0003
Address	1-6-1Miyahara,Yodogawa-ku,Osakashi, Osaka,Japan
TEL	06-6150-2478
Homepage URL
Email	takuse-hitoshi@linical.co.jp

Sponsor
Institute	AstraZeneca K.K.
Institute
Department

Funding Source
Organization	AstraZeneca K.K.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Linical Co.,Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	N/A
Address	N/A
Tel	N/A
Email	N/A

Secondary IDs
Secondary IDs	YES
Study ID_1	D081LR00002
Org. issuing International ID_1	AstraZeneca K.K.
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions

Institutions

北海道大学病院（北海道）、函館五稜郭病院（北海道）、弘前大学医学部附属病院（青森県）、奈良県立医科大学附属病院（奈良県）、香川大学医学部附属病院（香川県）、札幌医科大学附属病院（北海道）、岡山大学病院（岡山県）、金沢大学附属病院（石川県）、宮崎大学医学部附属病院（宮崎県）、横浜市立大学附属 市民総合医療センター（神奈川県）、名古屋市立大学病院（愛知県）、名古屋大学医学部附属病院（愛知県）、鳥取大学医学部附属病院（鳥取県）、近畿大学病院（大阪府）、神戸市立医療センター中央市民病院（兵庫県）、岐阜大学医学部附属病院（岐阜県）、東京慈恵会医科大学附属 柏病院（千葉県）、横浜市立大学附属病院（神奈川県）、埼玉医科大学総合医療センター（埼玉県）、愛媛大学医学部附属病院（愛媛県）、神戸大学医学部附属病院（兵庫県）、山口大学医学部附属病院（山口県）、独立行政法人 国立病院機構 呉医療センター・中国がんセンター（広島県）、筑波大学附属病院（茨城県）

Other administrative information
Date of disclosure of the study information	2020 Year 05 Month 25 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2020 Year 05 Month 07 Day
Date of IRB	2020 Year 05 Month 25 Day
Anticipated trial start date	2020 Year 06 Month 01 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry	2021 Year 04 Month 20 Day
Date trial data considered complete	2021 Year 04 Month 26 Day
Date analysis concluded	2021 Year 05 Month 31 Day

Other

Other related information

<Study Design> This study is a multi-center, prospective cohort study in patients with mCRPC. In this study, 155 patients (expected recruitment patients: maximum 205 patients) will be enrolled from approximately 20~30 sites in Japan. Index date is defined as the date diagnosed as mCRPC between 2014 and 2018. Demographic and clinical characteristics refer to latest value in index year retrospectively . The follow up period will be until Dec 31st2020 . After informed consent, it confirms eligibility criteria excluding exclusion criteria No.1.If it meets these criteria, tumor samples will be sent to Myriad Genetics Inc. to analyze HRR-related gene mutations. Eligibility criteria and "Archived tumor sample status" are collected at the screening. If HRR-related gene mutation test is successful, mCRPC patients are able to enroll this study after confirming all eligibility criteria. If it is failure, they can't register in this study because it meets Exclusion criteria No.1. We collect patients' background, demographics treatment pattern, clinical outcomes, and real-world effectiveness of treatment from Electric medical records . Archived formalin-fixed paraffin-embedded (FFPE) tumor samples will be collected from each site and HRR-related gene mutations analysed by Myriad Genetics Inc. and the tumor samples delivered by SRL

Management information
Registered date	2020 Year 05 Month 25 Day
Last modified on	2021 Year 09 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046247