UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012057 |
|---|---|
| Receipt number | 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 | 2023/01/18 17:40:54 |
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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 | Masahiro |
| Middle name | |
| Last name | Hiraoka |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Radiotherapy
Zip code
606-8501
Address
54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3417
hiraok@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Mizowaki |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Radiotherapy
Zip code
606-8507
Address
54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3762
Homepage URL
mizo@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Radiation Oncology & Image-applied Therapy, Kyoto University Graduate School of Medicine
Institute
Department
Personal name
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
54, Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-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
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
https://academic.oup.com/jrr/article/59/5/656/5061905
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
24
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
| 2023 | Year | 01 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
4 had low-risk, and 20 had intermediate-risk prostate cancer.
Participant flow
Patients were treated with external-beam radiation therapy after neoadjuvant hormonal therapy.
Adverse events
Regarding the acute toxicities (the primary endpoint), no grade 3 or higher toxicities were not observed. Regarding the late toxicities (the secondary endpoint), no grade 2 or higher toxicities were not observed.
Outcome measures
Regarding the primary endpoint, no grade 3 or higher acute toxicities were not observed.
Regarding the secondary and points, no grade 2 or higher late toxicity was observed and the 2-year biochemical recurrence-free survival rate was 95.8%.
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
| 2013 | Year | 11 | Month | 27 | Day |
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
| 2023 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014072
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