UMIN-CTR Clinical Trial

Basic information
Public title	Clinical trials about the correlation of change and PSA of the MRI (DWI-ADC) after a treatment halfway point and the end of treatment radiotherapy for prostate cancer
Acronym	Correlation of change and PSA of the MRI after a treatment halfway point and the end of treatment radiotherapy for prostate cancer
Scientific Title	Clinical trials about the correlation of change and PSA of the MRI (DWI-ADC) after a treatment halfway point and the end of treatment radiotherapy for prostate cancer
Scientific Title:Acronym	Correlation of change and PSA of the MRI after a treatment halfway point and the end of treatment radiotherapy for prostate cancer
Region	Japan

Condition
Condition	prostate cancer
Classification by specialty	Urology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Correlative of examines MRI-ADC and the value with the PSA test in radiotherapy for prostate cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	A correlation is seen in MRI image findings and a value of the blood test PSA
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	50 years-old <=
Age-upper limit	90 years-old >
Gender	Male
Key inclusion criteria	Performance status is the patient of 0 or 1. The patients that a written consent was obtained.
Key exclusion criteria	Patient with no informed consent.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name tanaka Middle name Last name Osamu
Organization	Gifu Municipal Hospital
Division name	Department of Radiation Oncology
Zip code	5008523
Address	7-1 kashima-cho Gifu Japan
TEL	058-251-1101
Email	c.bluered@gmail.com

Public contact
Name of contact person	1st name OSAMU Middle name Last name TANAKA
Organization	Gifu Municipal Hospital
Division name	Department of Radiation Oncology
Zip code	5008523
Address	Gifu
TEL	+819076730893
Homepage URL
Email	c.bluered@gmail.com

Sponsor
Institute	Gifu Municipal Hospital
Institute
Department

Funding Source
Organization	self
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Asahi University
Address	3-23 Hashimoto-cho
Tel	+819076730893
Email	c.bluered@gmail.com

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	2016 Year 06 Month 07 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	Completed
Date of protocol fixation	2016 Year 05 Month 17 Day
Date of IRB	2016 Year 05 Month 10 Day
Anticipated trial start date	2016 Year 06 Month 07 Day
Last follow-up date	2017 Year 03 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We observe a state of prostate cancer of the patients and a correlation with the blood test PSA using noninvasive MR imaging

Management information
Registered date	2016 Year 06 Month 07 Day
Last modified on	2019 Year 06 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026097