UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010295 |
|---|---|
| Receipt number | R000010947 |
| Scientific Title | Phase 1/2 clinical trial of image-guided hypofractionated intensity-modulated radiotherapy/volumetric modulated arc therapy for localized low- or intermediate-risk prostate cancer |
| Date of disclosure of the study information | 2013/03/22 |
| Last modified on | 2023/04/11 17:55:17 |
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Basic information
Public title
Phase 1/2 clinical trial of image-guided hypofractionated intensity-modulated radiotherapy/volumetric modulated arc therapy for localized low- or intermediate-risk prostate cancer
Acronym
Image-guided IMRT/VMAT for localized prostate cancer
Scientific Title
Phase 1/2 clinical trial of image-guided hypofractionated intensity-modulated radiotherapy/volumetric modulated arc therapy for localized low- or intermediate-risk prostate cancer
Scientific Title:Acronym
Image-guided IMRT/VMAT for localized 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 efficacy of image-guided hypofractionated intensity-modulated radiotherapy/volumetric modulated arc therapy of 70.2Gy in 27 fractions using fiducial gold markers for localized low- or intermediate-risk prostate cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
5-y biochemical relapse free survival
Key secondary outcomes
5-y distant metastasis free survival
5-y cause-specific survival
5-y overall survival
Toxicity (acute and late)
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 | Maneuver |
Interventions/Control_1
Patients are treated with image-guided hypo fractionated IMRT/VMAT (67.6Gy/26fx.) using fiducial gold markers in the prostate.
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
1) Prostate adenocarcinoma is proven.
2) Patient should receive MRI examination before treatment.
3) cT1-T2N0M0, Gleason score<or=7, pretreatment PSA <20ng/ml
4) ECOG PS 0-1
5) Patients must sign informed consent form prior to registration
Key exclusion criteria
1) Prior pelvic radiotherapy
2) Small cell carcinoma
3) cT3-4, exist of metastasis
4) Prior prostatectomy
5) Concurrent invasive cancers or collagen disease
6) PSA failure following hormonal therapy
7) If the attending physician judges the case inappropriate.
8) Gold allergy
9) Severe diabetes mellitus
10) Usage of anticoagulants/antiaggregant
11) Biochemical failure after hormonal therapy
12) Difficult to comply with dose constraints
13) IPSS>or=20
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Takeda |
Organization
Health Sciences, Tohoku University Graduate School of Medicine
Division name
Department of Therapeutic Radiology
Zip code
980-8575
Address
2-1, Seiryomachi, Aobaku, Senddaishi
TEL
022-717-7909
ken.takeda.a3@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Takeda |
Organization
Tohoku University Hospital
Division name
Department of Radiation Oncology
Zip code
980-8574
Address
1-1, Seiryomachi, Aobaku, Sendaishi
TEL
022-717-7312
Homepage URL
ken.takeda.a3@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University Hospital Clinical Research Ethics Committee
Address
1-1, Seiryomachi, Aobaku, Sendaishi
Tel
022-717-7145
med-kenkyo@bureau.tohoku.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
東北大学病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | Month | 22 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
12
Results
A total of 12 patients were enrolled from March 2013 to April 2017 after institutional ethics committee approval. The study was terminated in November 2017 because the target number was not reached. No serious adverse events of Grade 3 or higher were observed in either the gastrointestinal tract or the urinary tract during the period. No biochemical recurrence was observed within the period.
Results date posted
| 2023 | Year | 04 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Prostate cancer cases in men in their 50s to 70s.
Participant flow
Participated by referral from the Department of Urology at Tohoku University Hospital or urological department at another Hospital.
Adverse events
No serious adverse events of Grade 3 or higher were observed in either the GI or GU.
Outcome measures
PSA failure, late side effect
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2012 | Year | 10 | Month | 23 | Day |
Last follow-up date
| 2017 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 01 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 22 | Day |
Last modified on
| 2023 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010947
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