UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Dynamic Contrast-Enhanced Magnetic Resonance Imaging Study for Biochemocal Failures after Radical Prostatectomy
Title of the study (Brief title)	DCE-MRI for BFRP
Region	Japan

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

Objectives
Narrative objectives1	To detect recurrence with dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) and biopsy for prostate bed for patients with bichemical failure after radical prostatectomy. And to deliver salvage radiation therapy with dose-edcalated IMRT.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Validity of DCE-MRI for PSA failure
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	To detect recurrence with 3-tesla dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) and biopsy for prostate bed for patients with bichemical failure after radical prostatectomy. And to deliver salvage radiation therapy. Especially for patients of whom recurrence is detected by DCE-MRI with acquired consent, dose-edcalated IMRT will be adapted.
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	Patients with pathologically proven prostate cancer who underwent radical prostatectomy and present biochemical failure after PSA nadir.
Key exclusion criteria	Patients who are at risk for MRI study, for local biopsy of prostate bed, who cannot make their own decision, or patients who are considered inadequate by attendant physicians.
Target sample size	50

Research contact person
Name of lead principal investigator	Kenshiro Shiraishi
Organization	The University of Tokyo Hospital
Division name	Department of Radiology
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL	0338155411
Email	kshiraishi-tky@umin.ac.jp

Public contact
Name of contact person	Kenshiro Shiraishi
Organization	The University of Tokyo Hospital
Division name	Department of Radiology
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL	0338155411
Homepage URL
Email	kshiraishi-tky@umin.ac.jp

Sponsor
Institute	The University of Tokyo Hospital
Institute
Department

Funding Source
Organization	Departmen of Radiology, The University of Tokyo Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2013 Year 01 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 07 Month 26 Day
Anticipated trial start date	2012 Year 07 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 01 Month 21 Day
Last modified on	2018 Year 01 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011494