UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031106 |
|---|---|
| Receipt number | R000035431 |
| Scientific Title | Multi-institutional prospective trial on safety and efficacy of high dose rate brachytherapy as monotherapy for prostate cancer. |
| Date of disclosure of the study information | 2018/02/01 |
| Last modified on | 2022/08/07 09:15:24 |
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Basic information
Public title
Multi-institutional prospective trial on safety and efficacy of high dose rate brachytherapy as monotherapy for prostate cancer.
Acronym
Multi-institutional prospective trial on safety and efficacy of high dose rate brachytherapy as monotherapy for prostate cancer.
Scientific Title
Multi-institutional prospective trial on safety and efficacy of high dose rate brachytherapy as monotherapy for prostate cancer.
Scientific Title:Acronym
Multi-institutional prospective trial on safety and efficacy of high dose rate brachytherapy as monotherapy 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 examine the safety and efficacy of high dose rate brachytherapy as monotherapy (27 Gy / 2 fractions) for prostate cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. The occurence of more than or equal to Grade 3 late adverse effects in two years.
2. 5 year PSA relapse free rate.
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
High dose rate brachytherapy (27 Gy / 2 fractions)
Androgen deprivation therapy according to risk classification.
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
| 80 | years-old | > |
Gender
Male
Key inclusion criteria
1) Pathologically diagnosed prostate adenocarcinoma.
2) T1c-3bN0M0
3) PSA value under 50 ng/ml
4) Gleason score 6-10
5) Low, intermediate, high and very high risk (NCCN risk classification 2016)
6) Age :20-80
7) Performance status (ECOG) 0-1
8) Written informed consent
9) Patient chooses this trial method.
Key exclusion criteria
1) Other cancers
2) Uncontrolled Diabetes Mellitus
3) Severe comobidity such as collagen disease, heart disease, respiratory disease and liver disease.
4) Patient with severe psychiatric disease.
5) Privious medical history of pelvic irradiation.
6) Privious medical history of surgery or HIFU for prostate cancer.
7) Chemotherapy (except androgen deprivation therapy) for prostate cancer.
8) Inflammatory bowel disease
9) IPSS score more than or equal to 22.
10) Difficult to protect dose constraints for normal tissue.
11) Attending physician judges it is not suitable for the study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Igaki |
Organization
National Cancer Center Hospital, Japan.
Division name
Department of Radiation Oncology
Zip code
1040045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
TEL
03-3542-2511
hirigaki@ncc.go.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Inaba |
Organization
National Cancer Center Hospital, Japan.
Division name
Department of Radiation Oncology
Zip code
1040045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
TEL
03-3542-2511
Homepage URL
koinaba@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital, Japan.
Department of Radiation Oncology.
Institute
Department
Personal name
Funding Source
Organization
Elekta K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Hospital Certified Review Board
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045 Japan
Tel
03-3542-2511
ncch-irb@ml.res.ncc.go.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
国立がん研究センター中央病院（東京都）、がん研究会有明病院（東京都）、北里大学病院（神奈川県）、関西医科大学総合医療センター（大阪府）、大阪医療センター（大阪府）、千葉大学医学部附属病院（千葉県）、九州医療センター（福岡県）、関西医科大学附属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 12 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 01 | Day |
Last modified on
| 2022 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035431
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