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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012057
Receipt No. R000014072
Scientific Title A clinical study on the safety of hypo-fractionated stereotactic intensity-modulated radiation therapy for prostate cancer
Date of disclosure of the study information 2013/10/17
Last modified on 2018/10/19

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Basic information
Public title A clinical study on the safety of hypo-fractionated stereotactic intensity-modulated radiation therapy for prostate cancer
Acronym hypo-fractionated stereotactic intensity-modulated radiation therapy for prostate cancer
Scientific Title A clinical study on the safety of hypo-fractionated stereotactic intensity-modulated radiation therapy for prostate cancer
Scientific Title:Acronym hypo-fractionated stereotactic intensity-modulated radiation therapy 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 the safety of stereotactic hypo-fractionated intensity-modulated radiation therapy for patients with low- to intermediate-risk prostate cancer.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Incidences of acute adverse events
Key secondary outcomes Incidences of late adverse events at 2 years
PSA recurrence-free suravival rate at 2 years

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 Hypo-fractionated stereotactic intensity-modulated radiotherapy (54Gy/15 fractions/3 weeks) is applied after 4 to 8 months neoadjubant hormonal (CAB) therapy.
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) Histo-pathologically confirmed as adenocarcinoma of the prostate.
2) Prostate cancer cases classified to low-risk or intermediate-risk based on the D'Amico's definition.
3) Age at the registration is >=50 and <80 years old.
4) Performance status is 0 or 1 with Cooperative Oncology Group definition.
5) Cases submitted a written informed consent.
Key exclusion criteria 1) Active double cancer
2) Uncontrolled diabetes mellitus (HbA1c>+8.4%)
3) Severe coexisting diseases such as collagen disease, heart disease, respiratory disease and liver disease.
4) Psychotic disease
5) History of pelvic irradiation
6) History of pelvic surgery except for appendectomy and femoral herniation.
7) Surgical managements to the prostate
8) Chemotherapy to the prostate cancer
9) Inflammatory bowel diseases
10) Cases who are difficult to discontinue the administration of anticoagulant drugs.
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiro Hiraoka
Organization Kyoto University Graduate School of Medicine
Division name Department of Radiotherapy
Zip code
Address 54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto
TEL 075-751-3417
Email hiraok@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Mizowaki
Organization Kyoto University Graduate School of Medicine
Division name Department of Radiotherapy
Zip code
Address 54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto
TEL 075-751-3762
Homepage URL
Email mizo@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Radiation Oncology & Image-applied Therapy, Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology in Japan
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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 京都大学医学部附属病院(京都府)

Other administrative information
Date of disclosure of the study information
2013 Year 10 Month 17 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://academic.oup.com/jrr/article/59/5/656/5061905
Number of participants that the trial has enrolled
Results
No grade 3 or higher acute toxicity was observed. 
With a minimum follow-up period of 2 years, no grade 2 or higher late toxicity was observed and the 2-year biochemical recurrence-free survival rate was 95.8%.
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 Completed
Date of protocol fixation
2013 Year 10 Month 11 Day
Date of IRB
Anticipated trial start date
2014 Year 02 Month 01 Day
Last follow-up date
2017 Year 10 Month 18 Day
Date of closure to data entry
2017 Year 10 Month 18 Day
Date trial data considered complete
2017 Year 10 Month 31 Day
Date analysis concluded
2017 Year 12 Month 01 Day

Other
Other related information A pilot study of highly hypofractionated intensity-modulated radiation therapy over 3 weeks for localized prostate cancer.
Nakamura K, Ikeda I, Inokuchi H, Takayama K, Inoue T, Kamba T, Ogawa O, Hiraoka M, Mizowaki T.
J Radiat Res. 2018 Sep 1;59(5):656-663. doi: 10.1093/jrr/rry060.
PMID: 30085048

Management information
Registered date
2013 Year 10 Month 16 Day
Last modified on
2018 Year 10 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014072

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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