UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	To study the safety and efficacy of hypofractionated intensity modulated radiotherapy for patients with intermediate-risk prostate cancer.
Title of the study (Brief title)	To study the safety and efficacy of hypofractionated IMRT for patients with intermediate-risk prostate cancer.
Region	Japan

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

Objectives
Narrative objectives1	To study the safety and efficacy of hypofractionated intensity modulated radiotherapy of 70 Gy in 28 fractions for patients with intermediate-risk prostate cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The rate of late adverse effects at three years
Key secondary outcomes

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	Device,equipment
Interventions/Control_1	Patients received 70Gy/28fxs to the prostate and the base of the seminal vesicle with IMRT.
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)Histologically confirmed prostate adenocarcinoma 2)One of the following combinations of factors: - Clinical stage T1b-2cN0M0, Gleason score 2-6, and prostate-specific antigen >10 but <20; - Clinical stage T1b-T2cN0M0, Gleason score 7, and prostate-specific antigen <20 3)ECOG-PS 0-1 4)No previous hormonal therapy or within 10 months after the start of hormonal therapy 5)Calcification in the prostate recognized on CT scans 6)Patients must sign informed consent form prior to registration
Key exclusion criteria	1) Small cell carcinoma 2) Previous or concurrent invasive cancers 3) Previous pelvic irradiation 4) Previous orchiectomy 5) Previous treatment of prostate cancer other than hormonal therapy 6) Cases judged by their physicians to be inappropriate as subjects
Target sample size	30

Research contact person
Name of lead principal investigator	Masahiko Oguchi M.D., Ph.D.
Organization	The Cancer Institute Hospital, Japanese Foundation for Cancer Research
Division name	Department of Radiation Oncology
Address	3-8-31 Ariake, Koto-ku, Tokyo 135-8550, JAPAN
TEL	03-3520-0111
Email	oguchi@jfcr.or.jp

Public contact
Name of contact person	Takuyo Kozuka M.D., Ph.D.
Organization	The Cancer Institute Hospital, Japanese Foundation for Cancer Research
Division name	Department of Radiation Oncology
Address	3-8-31 Ariake, Koto-ku, Tokyo 135-8550, JAPAN
TEL	03-3520-0111
Homepage URL
Email	takuyo.kozuka@jfcr.or.jp

Sponsor
Institute	Department of Radiation Oncology, The Cancer Institute Hospita, the Japanese Fundation for Cancer Reseach
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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	2010 Year 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 12 Month 15 Day
Anticipated trial start date	2010 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 02 Month 21 Day
Last modified on	2018 Year 03 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000003899