UMIN-CTR Clinical Trial

Basic information
Public title	Robotic stereotactic body radiotherapy for prostate cancer
Acronym	Robotic stereotactic body radiotherapy for prostate cancer
Scientific Title	Robotic stereotactic body radiotherapy for prostate cancer
Scientific Title:Acronym	Robotic stereotactic body radiotherapy 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 evaluate safety and effectiveness of hypofractionated robotic stereotactic body radiotherapy for localized prostate cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	2-year late genitourinary and gastrointestinal toxicity rates
Key secondary outcomes	2-year biochemical failure-free survival, QOL (EPIC, IPSS), and dosimetry

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	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Stereotactic body radiotherapy. 36.25Gy/5fr.
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)Biopsy-proven prostate adenocarcinoma 2)MRI, CT, bone scintigraphy were done, and no lymph node or distant metastasis was detected 3)T1c-T2cN0M0 4)Gleason score=7 or less, excluding 4+3 5)PSA <20 ng/ml 6)Well preserved major organ function fulfilling laboratory test limits as below a)White blood cell count>=3000/mm3 b)Hemoglobin>=10.0g/dl c)Platelet count>=100000/mm3 d)Serum creatinine<=2.0mg/dl e)GOT<=100U/L f)GPT<=100U/L g)No apparent deficiency of hematological tests 7)Age >=20, <80 8)Written informed consent obtained
Key exclusion criteria	1)Associated with other malignancies 2)Diabetes mellitus uncontrollable with medication 3)Unstoppable anticoagulant drugs 4)Severe neurocognitive disease 5)Collagen disease 6)Previous surgery or irradiation to the pelvis 7)Previous TUR-P 8)Severe BPH or lower urinaly tract symptoms 9)Contraindicated for percutaneous fiducial insertion 10)Neoadjucant hormone therapy >1 year 11)Castration-resistant prostate cancer 12)Miscellaneous inappropriate conditions judged by physicians
Target sample size	25

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takahisa Eriguchi
Organization	Saiseikai Yokohama City Tobu Hospital
Division name	Department of radiation oncology
Zip code
Address	3-6-1, Shimosueyoshi, Tsurumi-ku, Yokohama, Kanagawa, Japan
TEL	045-576-3000
Email	t_eriguchi@tobu.saiseikai.or.jp

Public contact
Name of contact person	1st name Middle name Last name Takahisa Eriguchi
Organization	Saiseikai Yokohama City Tobu Hospital
Division name	Department of radiation oncology
Zip code
Address	3-6-1, Shimosueyoshi, Tsurumi-ku, Yokohama, Kanagawa, Japan
TEL	045-576-3000
Homepage URL
Email	t_eriguchi@tobu.saiseikai.or.jp

Sponsor
Institute	Saiseikai Yokohama City Tobu Hospital
Institute
Department

Funding Source
Organization	self funding
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
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	2017 Year 08 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	2017 Year 07 Month 24 Day
Date of IRB	2017 Year 07 Month 24 Day
Anticipated trial start date	2017 Year 08 Month 01 Day
Last follow-up date	2021 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	2017 Year 07 Month 27 Day
Last modified on	2021 Year 05 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032250