UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility study of stereotactic body radiotherapy for prostate cancer
Title of the study (Brief title)	Feasibility study of CyberKnife for prostate cancer
Region	Japan

Condition
Condition	Early stage prostate cancer (T1-T2c and iPSA 10-20 ng/mL and GS=<6, T1-T2c and iPSA <10 ng/mL and GS=7)
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effectiveness and toxicity of Hypofractionated radiotherapy (35 Gy/5 fractions/ 10 days) using CyberKnife for early stage prostate cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Rate of acute adverse events
Key secondary outcomes	2-year PSA failure rate, 2-year clinical failure rate, recurrence pattern, late adverse events, rate of perprotocol, evaluation of dose distribution

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	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	50 years-old <=
Age-upper limit	85 years-old >
Gender	Male
Key inclusion criteria	1) Adenocarcinoma 2) Low risk (T1-T2a and iPSA <10 ng/mL and GS=<6), or a partof Intermediate risk (T1-T2a and iPSA 10-20 ng/mL and GS=<6, or T1-T2a and iPSA <10 ng/mL and GS=7) 3) 50-84 years 4) No hormonral therapy or less than 8 months 5) PS 0-1 6) No privious radiotherapy histoly 7) Written informed consent
Key exclusion criteria	1) active double cancer(s) 2) Uncontrol DM 3) collagen disease, heart failure, sever respiratoy disease 4) Mental disease 5) Major operation of pelvic site 6) Surgery for prostate cancer 7) Chemotherapy for prostate cancer 8) Crohn's disease, Uncerlative colitis 9) Anti-coagulation agent 10) IPSS =<20 11) Artificial head
Target sample size	20

Research contact person
Name of lead principal investigator	Naoto Shikama
Organization	Saitama Medical University, International Medical Center
Division name	Radiation Oncology
Address	1397-1 Yamane, Hidaka-shi, 350-1298, Saitama Japan
TEL	042-984-4136
Email	nshikama0525@gmailcom

Public contact
Name of contact person	Naoto Shikama
Organization	Saitama Medical University, International Medical Center
Division name	Radiation Oncology
Address	1397-1 Yamane, Hidaka-shi, 350-1298, Saitama Japan
TEL	042-984-4136
Homepage URL
Email	nshikama0525@gmail.com

Sponsor
Institute	Radiation Oncology, Saitama Medical University, International Medical Center
Institute
Department

Funding Source
Organization	the Health and Labor Sciences Research Grant (H24-007)
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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

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	埼玉医科大学国際医療センター（埼玉県）

Other administrative information
Date of disclosure of the study information	2012 Year 12 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 10 Month 25 Day
Anticipated trial start date	2012 Year 12 Month 15 Day
Last follow-up date	2016 Year 09 Month 30 Day
Date of closure to data entry	2016 Year 10 Month 01 Day
Date trial data considered complete	2016 Year 10 Month 01 Day
Date analysis concluded	2016 Year 10 Month 01 Day

Related information
URL releasing protocol	http://www.saitama-med.ac.jp/kokusai/
Publication of results	Published
URL releasing results	https://doaj.org/toc/1920-454X?source=%7B%22query%22%3A%7B%22filtered%22%3A%7B%22filter%22%3A%7B%22b
Results	The incidence of >grade 2 acute toxicity in all sites and that in the rectum after EHF-RT of 35 Gy in five fractions were 30% and 20%, respectively. High rectum-V28Gy was associated with grade 2 acute rectal toxicity after EHF-RT for early prostate cancer.
Other related information

Management information
Registered date	2012 Year 12 Month 23 Day
Last modified on	2016 Year 12 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011280