UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multi-institutional retrospective analysis of high-dose-rate brachytherapy combined with external beam radiotherapy for prostate cancer
Title of the study (Brief title)	Multi-institutional study of HDR combined with EBRT for prostate cancer
Region	Japan Asia(except Japan)

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

Objectives
Narrative objectives1	to report the results of prostate cancer patients treated with high-dose-rate brachytherapy combined with external beam radiotherapy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	biochemical disease free survival
Key secondary outcomes	cumulative toxicity rate overall survival

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	na
Key exclusion criteria	na
Target sample size	3000

Research contact person
Name of lead principal investigator	hiromichi ishiyama
Organization	kitasato university school of medicine
Division name	department of radiology and radiation oncology
Address	1-15-1 kitasato sagamiharashi-minamiku
TEL	042-778-8453
Email	hishiyam@kitasato-u.ac.jp

Public contact
Name of contact person	hiromichi ishiyama
Organization	kitasato university shool of medicine
Division name	department of radiology and radiation oncology
Address	1-15-1 kitasato sagamiharashi-minamiku
TEL	042-778-8453
Homepage URL
Email	hishiyam@kitasato-u.ac.jp

Sponsor
Institute	kitasato univerisity
Institute
Department

Funding Source
Organization	Japanese Group of Brachytherapy-Japanese Society for Radiation Oncology Japanese Radiation Oncology Study Group Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Other
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	2016 Year 05 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 21 Day
Anticipated trial start date	2015 Year 10 Month 21 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	Published
URL releasing results
Results	High-dose-rate brachytherapy combined with external beam radiotherapy was an effective and safe treatment for localized prostate cancer. Combination of long-term ADT was suggested to be necessary, even for HDR brachytherapy, and was useful in suppressing late toxicities. Meanwhile, pelvic irradiation was suggested to have an adverse effect on OS of our study population.
Other related information	study design: multi-institutional retrospective analysis Candidate: prostate cancer patients treated by high-dose-rate brachytherapy before 1995 and followed at least 2 years. Dead patients within 2 years are included. Method: review of medical record. Items: age, TNM stage, Gleason score, PSA value, history of TUR-p, with or without hormonal therapy, radiation dose, number of fractionations, type of external beam radiation therapy, follow up period, tumor control, survival period, toxicity rate

Management information
Registered date	2016 Year 05 Month 30 Day
Last modified on	2017 Year 05 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025969