UMIN-CTR Clinical Trial

Basic information
Public title	Multicenter prospective observational study on metastatic hormone-naive prostate cancer
Acronym	Multicenter prospective observational study on metastatic hormone-naive prostate cancer
Scientific Title	Multicenter prospective observational study on metastatic hormone-naive prostate cancer
Scientific Title:Acronym	Multicenter prospective observational study on metastatic hormone-naive prostate cancer
Region	Japan

Condition
Condition	metastatic hormone-naive prostate cancer
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the clinical outcomes of metastatic hormone-naive prostate cancer in Japan
Basic objectives2	Others
Basic objectives -Others	To evaluate the clinical practice of metastatic hormone-naive prostate cancer in Japan
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Clinical practice and outcomes of metastatic hormone-naive prostate cancer
Key secondary outcomes

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	Not applicable
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	Metastatic hormone naive prostate cancer
Key exclusion criteria	Patients for whom it is impossible to obtain consent
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Yasuhisa Middle name Last name Fujii
Organization	Tokyo Medical and Dental University
Division name	Urology
Zip code	113-8519
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-5295
Email	ikyouro@tmd.ac.jp

Public contact
Name of contact person	1st name Soichiro Middle name Last name Yoshida
Organization	Tokyo Medical and Dental University
Division name	Urology
Zip code	Tokyo Medical and Dental University
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-5295
Homepage URL
Email	ikyouro@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokyo Medical and Dental University
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel	03-5803-5295
Email	ikyouro@tmd.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 06 Month 24 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	Open public recruiting
Date of protocol fixation	2021 Year 04 Month 21 Day
Date of IRB	2021 Year 04 Month 28 Day
Anticipated trial start date	2021 Year 04 Month 28 Day
Last follow-up date	2026 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Prospective registration of clinical and pathological information obtained from medical records

Management information
Registered date	2021 Year 06 Month 24 Day
Last modified on	2021 Year 06 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050995