UMIN-CTR Clinical Trial

Basic information
Public title	Prospective study of low dose rate brachytherapy combined with stereotactic body radiotherapy for very-high risk prostate cancer
Acronym	Prospective study of low dose rate brachytherapy combined with stereotactic body radiotherapy for very-high risk prostate cancer
Scientific Title	Prospective study of low dose rate brachytherapy combined with stereotactic body radiotherapy for very-high risk prostate cancer
Scientific Title:Acronym	Prospective study of low dose rate brachytherapy combined with stereotactic body radiotherapy for very-high risk prostate cancer
Region	Japan

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

Objectives
Narrative objectives1	To examine the safety and effectiveness of low dose rate brachytherapy combined with stereotactic body radiotherapy for very-high risk prostate cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	3-year actuarial Grade 3 toxicity rate
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	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	radiotherapy
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	80 years-old >
Gender	Male
Key inclusion criteria	1) pathologically confirmed adenocarcinoma 2) >=T3b or Gleason socre >=9 3) performance status >=1
Key exclusion criteria	1) active tumor in other organs 2) uncontrolled diabetes 3) Severe concomitant diseases 4) psychiatric disease 5) history of pelvic irradiation 6) history of chemotherapy 7) physician's estimation
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Hiromichi Middle name Last name Ishiyama
Organization	Kitasato University school of medicine
Division name	Department of Radiation Oncology
Zip code	252-0374
Address	1-15-1 kitasato, satamiharashi minamiku,kanagawa,Japan
TEL	042-778-8453
Email	hishiyam@kitasato-u.ac.jp

Public contact
Name of contact person	1st name Hiromichi Middle name Last name Ishiyama
Organization	Kitasato university school of medicine
Division name	Department of radiation oncology
Zip code	252-0374
Address	1-15-1 kitasato, sagamiharashi minamiku, kanagawa, japan
TEL	042-778-8453
Homepage URL
Email	hishiyam@kitasato-u.ac.jp

Sponsor
Institute	Kitasato university
Institute
Department

Funding Source
Organization	kitasato univeristy
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	Kitasato university
Address	1-15-1 kitasato, sagamiharashi minamiku, kanagawa, japan
Tel	042-778-8453
Email	hishiyam@kitasato-u.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	2019 Year 07 Month 01 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	2019 Year 07 Month 01 Day
Date of IRB	2019 Year 08 Month 07 Day
Anticipated trial start date	2019 Year 08 Month 07 Day
Last follow-up date	2026 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 05 Month 07 Day
Last modified on	2022 Year 05 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041771