UMIN-CTR Clinical Trial

Basic information
Public title	A Prospective Observational Study of Stereotactic Body Radiotherapy for Favorable Risk Prostate Cancer
Acronym	A Prospective Observational Study of Stereotactic Body Radiotherapy for Favorable Risk Prostate Cancer
Scientific Title	A Prospective Observational Study of Stereotactic Body Radiotherapy for Favorable Risk Prostate Cancer
Scientific Title:Acronym	A Prospective Observational Study of Stereotactic Body Radiotherapy for Favorable Risk Prostate Cancer
Region	Japan

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

Objectives
Narrative objectives1	The purpose of this study is to evaluate the efficacy and toxicity of stereotactic body radiation therapy (SBRT) for prostate cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Five-year biochemical relapse-free survival
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	1) Primary adenocarcinoma of the prostate 2) T1c-T3bN0M0 (UICC TNM 8th Edition) 3) Age >= 20 years old 4) ECOG-PS 0-2 5) No previous pelvic radiotherapy 6) Fiducial marker guided prostate radiotherapy can be used 7) Hydrogel spacers are implanted 8) Able to insert indwelling bladder catheter 9) Written informed consent
Key exclusion criteria	1) Treated with brachytherapy 2) Received anti-androgen therapy for more than 1 year 3) After radical prostatectomy 4) MRI cannot be performed 5) Inflammatory bowel disease 6) Bilateral total hip arthroplasty 7) Synchronous or metachronous malignancies 8) Prostate volume larger than 80 cm3 on planning CT 9) Patients who attending physicians consider to be inappropriate due to other reasons mentioned above
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Hisanori Middle name Last name Ariga
Organization	Iwate medical university
Division name	Department of radiation oncology
Zip code	028-3685
Address	2-1-1, Idaidori, Yahaba-cho, Shiwa-gun, Iwate
TEL	019-613-7111
Email	hariga2525@gmail.com

Public contact
Name of contact person	1st name Koyo Middle name Last name Kikuchi
Organization	Iwate medical university
Division name	Department of radiation oncology
Zip code	028-3685
Address	2-1-1, Idaidori, Yahaba-cho, Shiwa-gun, Iwate
TEL	019-613-7111
Homepage URL
Email	kikuchi@iwate-med.ac.jp

Sponsor
Institute	Iwate medical university
Institute
Department

Funding Source
Organization	Iwate medical university
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Iwate medical university
Address	1-1-1, Idaidori, Yahaba-cho, Shiwa-gun, Iwate
Tel	019-651-5111
Email	kenkyu-rinri@j.iwate-med.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	2021 Year 09 Month 06 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	Open public recruiting
Date of protocol fixation	2020 Year 12 Month 01 Day
Date of IRB	2020 Year 11 Month 26 Day
Anticipated trial start date	2020 Year 12 Month 01 Day
Last follow-up date	2025 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2021 Year 09 Month 06 Day
Last modified on	2021 Year 09 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051833