UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of hypofractionated intensity-modulated radiation therapy using image-guided radiation techniques for prostate cancer
Title of the study (Brief title)	Phase II study of hypofractionated radiation therapy for prostate cancer
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the safety and efficacy of hypofractionated intensity-modulated radiation therapy using image-guided radiation techniques for prostate cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Incidence of late morbidity
Key secondary outcomes	Incidence of acute morbidity, biochemical failure free survival, clinical progression free survival, 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	Maneuver
Interventions/Control_1	Intensity-modulated radiation therapy with 70 Gy delivered at 2.5-Gy/fraction using image-guided radiation techniques
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 cancer(adenocarcinoma) 2) Low or intermediate risk prostate cancer(T1-T2c and PSA =<20 and G =<7) or high risk cancer with one of high risk factors (T3a, 20< PSA =<30 or G=8,9) 3) 50y.o. <= age < 80 y.o. 4) ECOG performance status 0-1 5))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 pulmonary disease, heart disease, kidney disease, liver disease) 4) Mental diseases which prevent from registration of this trial 5) History of pelvic radiation therapy 6) History of abdominal or pelvic surgery 7) History of prostate surgery including HIFU 8) History of chemotherapy for prostate cancer 9) Patients with inflammatory bowel disease 10) Patients treated with anticoagulant 11) IPSS >= 20 12) Risk organs are too close to the PTV to keep dose constraints. 13) Patients with metal artifacts in pelvic CT images.
Target sample size	130

Research contact person
Name of lead principal investigator	Yoshikazu Kagami
Organization	Showa University School of Medicine
Division name	Department of Radiology
Address	Hatanodai 1-5-8, Tokyo, Japan
TEL	03-6426-3228
Email	kagami@med.showa-u.ac.jp

Public contact
Name of contact person	Katsumasa Nakamura
Organization	Kyushu University Hospital
Division name	Department of Radiology
Address	Maidashi 3-1-1, Fukuoka, Japan
TEL	092-642-5695
Homepage URL	http://plaza.umin.ac.jp/~hypo_rt/
Email	nakam@radiol.med.kyushu-u.ac.jp

Sponsor
Institute	Ministry of Health, Labour and Welfare scientific research Kagami squad
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2012 Year 07 Month 02 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2012 Year 04 Month 20 Day
Anticipated trial start date	2012 Year 07 Month 01 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol	http://hypo_rt.umin.jp/index.html
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 04 Month 22 Day
Last modified on	2017 Year 04 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009201