UMIN-CTR Clinical Trial

Basic information
Public title	A prospective observational study of comparison between radical prostatectomy and radiation therapy for high risk prostate cancer
Acronym	A prospective observational study of comparison between radical prostatectomy and radiation therapy for high risk prostate cancer
Scientific Title	A prospective observational study of comparison between radical prostatectomy and radiation therapy for high risk prostate cancer
Scientific Title:Acronym	A prospective observational study of comparison between radical prostatectomy and radiation therapy for high risk prostate cancer
Region	Japan

Condition
Condition	prostate cancer
Classification by specialty	Endocrinology and Metabolism Endocrine surgery Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	In order to prevent death of prostate cancer, we aim to detect prostate cancer as early as possible and aim at it.
Basic objectives2	Others
Basic objectives -Others	By clarifying the characteristics of treatment, we aim to construct a system that can provide optimal treatment to patients.
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Blood / urinalysis, physical findings, tumor assessment of prostate and pelvic lymph nodes (non-contrast MRI) are performed every 3 months.
Key secondary outcomes	Evaluation of complications (international prostate symptom score IPSS (6)), quality of life after surgery (EuroQol 5 Dimension; EQ - 5D (7) and FACT - P (8)) and erectile function (International erectile function score; Evaluation of IIEF 5 (9)) every 3 months.

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	Patients suspected of having prostate cancer due to PSA at the first visit. Patients diagnosed with high-risk prostate cancer who have no distant metastases. Patients over the age of 20 at the time of obtaining consent. Patients who can obtain written informed consent.
Key exclusion criteria	Patients who were not tested for high-risk prostate cancer or were found to have metastatic prostate cancer as a result of further testing (however, data and samples up to that point are used for preliminary analysis).
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Middle name Last name Koshiro Nishimoto
Organization	Saitama Medical University International Medical Center
Division name	UroOncology
Zip code
Address	1397-1 Yamane, Hidaka, Saitama 350-1241, Japan
TEL	+81-42-984-4111
Email	k.nishimoto@keio.jp

Public contact
Name of contact person	1st name Middle name Last name Koshiro Nishimoto
Organization	Saitama Medical University International Medical Center
Division name	UroOncology
Zip code
Address	1397-1 Yamane, Hidaka, Saitama 350-1241, Japan
TEL	+81-42-984-4111
Homepage URL	http://www.international.saitama-med.ac.jp/chiken/results.php
Email	k.nishimoto@keio.jp

Sponsor
Institute	Saitama Medical University International Medical Center
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	埼玉医科大学国際医療センター

Other administrative information
Date of disclosure of the study information	2018 Year 07 Month 10 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	Enrolling by invitation
Date of protocol fixation	2018 Year 04 Month 20 Day
Date of IRB	2018 Year 05 Month 02 Day
Anticipated trial start date	2018 Year 05 Month 02 Day
Last follow-up date	2030 Year 03 Month 31 Day
Date of closure to data entry	2031 Year 03 Month 31 Day
Date trial data considered complete	2031 Year 03 Month 31 Day
Date analysis concluded	2031 Year 03 Month 31 Day

Other
Other related information	None

Management information
Registered date	2018 Year 07 Month 10 Day
Last modified on	2020 Year 08 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038013