UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of additional indication on extreme hypofractionated stereotactic body radiation therapy for prostate cancer
Acronym	Phase II study of additional indication on extreme hypofractionated stereotactic body radiation therapy for prostate cancer
Scientific Title	Phase II study of additional indication on extreme hypofractionated stereotactic body radiation therapy for prostate cancer
Scientific Title:Acronym	Phase II study of additional indication on extreme hypofractionated stereotactic body radiation therapy for prostate cancer
Region	Japan

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

Objectives
Narrative objectives1	To explore the safety and efficacy of extreme hypofractionated stereotactic body radiation therapy for localized prostate cancer expanded indication to high risk group
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Incidence of 5 year chronic adverse events
Key secondary outcomes	Incidence of acute adverse events, Incidence of 5 year biochemical failure free survival, Incidence of 5 year clinical failure free survival, Incidence of 5 year overall survival

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	Extreme hypofractionated stereotactic body radiation therapy
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	80 years-old >=
Gender	Male
Key inclusion criteria	(1) Histologically proved prostate adenocarcinoma (2) Low or intermediate or highg risk prostate cancer (T1-T3aN0M0 and PSA=<50 and GS:6-10) (3) 50y.o. =< age =< 80 y.o. (4) ECOG performance status 0-1 (5) Posible to insert fiducial gold markers (6) Written informed consent
Key exclusion criteria	(1) Cancer patients with a duplication of activity (2) Patients with severe or uncontrollable diabetes (3) Serious medical complications (uncontrollable collagen disease, heart disease, interstitial pneumonia, liver cirrhosis, etc.) (4) Mental diseases which prevent from registration of this trial (5) History of pelvic radiation therapy (6) History of pelvic surgery (7) History of prostate surgery including TUR-P and HIFU (8) History of chemotherapy for prostate cancer (9) Patients with inflammatory bowel disease (10) Patients treated with anticoagulant (11) IPSS => 20 (12) Persons who are judged inappropriate by the researcher
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takeshi Akiba
Organization	Tokai university school of medicine
Division name	Radiation oncology
Zip code
Address	143 shimokasuya isehara kanagawa japan
TEL	0463-93-1121
Email	takiba@is.icc.u-tokai.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Takeshi Akiba
Organization	Tokai university school of medicine
Division name	Radiation oncology
Zip code
Address	143 shimokasuya isehara kanagawa japan
TEL	0463-93-1121
Homepage URL
Email	takiba@is.icc.u-tokai.ac.jp

Sponsor
Institute	Tokai university
Institute
Department

Funding Source
Organization	Tokai university
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

Other administrative information
Date of disclosure of the study information	2018 Year 05 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	Terminated
Date of protocol fixation	2018 Year 02 Month 20 Day
Date of IRB	2018 Year 02 Month 20 Day
Anticipated trial start date	2018 Year 05 Month 01 Day
Last follow-up date	2022 Year 03 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	2018 Year 04 Month 28 Day
Last modified on	2022 Year 03 Month 26 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036973