UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035990 |
|---|---|
| Receipt number | R000040993 |
| Scientific Title | Practice in the Radiation Therapy for Stage D1 Prostate Cancer: Survey of the Japanese Radiation Oncology Study Group (JROSG) |
| Date of disclosure of the study information | 2019/02/24 |
| Last modified on | 2022/02/26 14:50:59 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Practice in the Radiation Therapy for Stage D1 Prostate Cancer: Survey of the Japanese Radiation Oncology Study Group (JROSG)
Acronym
D1 prostate
Scientific Title
Practice in the Radiation Therapy for Stage D1 Prostate Cancer: Survey of the Japanese Radiation Oncology Study Group (JROSG)
Scientific Title:Acronym
D1 prostate
Region
| Japan |
Condition
Condition
Radiation therapy for stage D1 prostate cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To retrospectively analyze the clinical outcomes of radiation therapy for stage D1 prostate cancer in Japan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall Survical
Key secondary outcomes
Progression-free survival, disease-free survival, adverse events rate
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Radiation therapy for stage D1 prostate cancer
Key exclusion criteria
There is no pathological diagnosis
Patients undergoing surgery for prostate cancer
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Toshiya |
| Middle name | |
| Last name | Maebayashi |
Organization
Nihon University school of medicine
Division name
Radiology
Zip code
173-8610
Address
Itabashi-ku
TEL
0339728111
maebayashi.toshiya@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshiya |
| Middle name | |
| Last name | Maebayashi |
Organization
Nihon University school of medicine
Division name
Radiology
Zip code
173-8610
Address
Itabashi-ku
TEL
0339728111
Homepage URL
maebayashi.toshiya@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University school of medicine
Institute
Department
Personal name
Funding Source
Organization
Nihon University school of medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University School of Medicine
Address
30-1 Oyaguchi Kami-cho Itabashi-ku
Tel
0339728111
maebayashi.toshiya@nihon-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
日本大学医学部附属板橋病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 24 | Day |
Related information
URL releasing protocol
https://jrosg.jp/%E3%83%97%E3%83%AD%E3%83%88%E3%82%B3%E3%83%BC%E3%83%AB/%E3%83%97%E3%83%AD%E3%83%88%
Publication of results
Partially published
Result
URL related to results and publications
2020 Annual Meeting American Society for Radiation Oncology (ASTRO)
Number of participants that the trial has enrolled
169
Results
The median follow-up period was 53 months (range, 9-99). Estimated 5-year overall and progression free survival rates were 84.6% and 69.3%, respectively.
Fifty-one (30.2%) patients developed biochemical recurrence.Multivariate analyses indicated that BED was the only significant prognostic factor for overall survival (p=0.01) and DSS (p=0.04).
Results date posted
| 2021 | Year | 08 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Clinical records of 169 patients with cT1-4N1M0 prostate cancer treated with definitive radiotherapy between 2011 and 2015
Participant flow
Clinical records of 169 patients with cT1-4N1M0 prostate cancer treated with definitive radiotherapy between 2011 and 2015
Adverse events
Regarding late adverse events, 12 (7.1%) and 11 (6.5%) patients experienced grade 2 or higher gastrointestinal and genitourinary toxicities, respectively.
Outcome measures
Multivariate analyses indicated that BED was the only significant prognostic factor for overall survival (p=0.01) and DSS (p=0.04)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 02 | Month | 13 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 11 | Day |
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 02 | Month | 26 | Day |
Date trial data considered complete
| 2022 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2023 | Year | 09 | Month | 01 | Day |
Other
Other related information
None
Management information
Registered date
| 2019 | Year | 02 | Month | 24 | Day |
Last modified on
| 2022 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040993
