UMIN-CTR Clinical Trial

Basic information
Public title	Hypofractionated radiotherapy for low and intermediate-risk prostate cancer using robot-tracking stereotactic radiotherapy -phase I/II clinical trial-
Acronym	Robot-tracking stereotactic radiotherapy for prostate cancer
Scientific Title	Hypofractionated radiotherapy for low and intermediate-risk prostate cancer using robot-tracking stereotactic radiotherapy -phase I/II clinical trial-
Scientific Title:Acronym	Robot-tracking stereotactic radiotherapy for prostate cancer
Region	Japan

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

Objectives
Narrative objectives1	To seek for optimal dose-fractionation and to evaluate safety and efficacy of hypfractionated short-term radiotherapy for low and intermediate-risk prostate cancer, using robotic streotactic radiotherapy machine equipped with a tumor-chasing device
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	Ratio of 2-year late adverse events (genitourinary and gaastrointestinal Grade 2 or more)
Key secondary outcomes	2-year biochemical control rate, QOL questionnaire (EPIC + SF-8), dosimetry (dose distribution etc. in radiation physics)

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	Other
Interventions/Control_1	1st dose level (7 Gy x 5 fractions = 35 Gy), 2nd dose level (7.5 Gy x 5 fractions = 37.5 Gy), 3rd dose level (8 Gy x 5 fractions = 40 Gy)
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 adenocarcinoma 2) no lymph node metastasis or distant metastasis proven by all of MRI, CT and bone scan 3) T1c-T2cN0M0 4) GS <=7 5) PSA <=20 6) No hormone therapy or less than 1-year neoadjuvant hormone therapy 7) WBC>3,000, Hb >10, Plt >10000, Cr <2, GOT <100, GPT<100 8) Age >20, <80 9) Informed consent
Key exclusion criteria	1) Active double cancer 2) Uncontrollable DM 3) Impossible to stop anticoagulate drugs 4) Severe brain disease 5) Collagen disease 6) Previous pelvic surgery or radiotherapy 7) Previous TUR-P 8) Severe BPH or dysuria 9) Disagree to implant of metallic marker 10) Hormone therapy > 1 year 11) Castration-resistant prostate cancer 12) PSA >20 13) Physician-rated contraindication
Target sample size	75

Research contact person
Name of lead principal investigator	1st name Takero Middle name Last name Hirata
Organization	Osaka University Graduate School of Medicine
Division name	Radiation Oncology
Zip code	5650871
Address	2-2 Yamadaoka, Suita, Osaka
TEL	06-6879-3482
Email	hirata@radonc.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Takero Middle name Last name Hirata
Organization	Osaka University Graduate School of Medicine
Division name	Radiation Oncology
Zip code	5650871
Address	2-2 Yamadaoka, Suita, Osaka
TEL	06-6879-3482
Homepage URL
Email	hirata@radonc.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Osaka University Graduate School of Medicine
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	Osaka University Graduate School of Medicine
Address	2-2 Yamadaoka, Suita, Osaka
Tel	06-6879-3345
Email	nakano-k@office.osaka-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	2014 Year 06 Month 20 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	No longer recruiting
Date of protocol fixation	2014 Year 05 Month 23 Day
Date of IRB
Anticipated trial start date	2014 Year 06 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 06 Month 20 Day
Last modified on	2019 Year 09 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016679