UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059723 |
|---|---|
| Receipt number | R000067922 |
| Scientific Title | Prospective Observational Study of Hypofractionated Postprostatectomy Salvage Radiation Therapy (HYPOST) |
| Date of disclosure of the study information | 2025/11/10 |
| Last modified on | 2025/11/10 15:25:33 |
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Basic information
Public title
Prospective Observational Study of Hypofractionated Postprostatectomy Salvage Radiation Therapy (HYPOST)
Acronym
HYPOST study
Scientific Title
Prospective Observational Study of Hypofractionated Postprostatectomy Salvage Radiation Therapy (HYPOST)
Scientific Title:Acronym
HYPOST study
Region
| Japan |
Condition
Condition
Postoperative biochemical recurrence of prostate cancer
Classification by specialty
| Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Salvage radiotherapy to the prostatic bed using conventional fractionation is widely performed as standard treatment for postoperative biochemical recurrence of prostate cancer. Several reports have demonstrated salvage radiotherapy using hypofractionated schedules, and a randomized phase III trial has proven its noninferiority to conventional fractionation. We intend to perform hypofractionated salvage radiotherapy at our institution going forward. However, since few facilities in Japan currently perform salvage hypofractionated radiotherapy, our objective is to prospectively evaluate the number of cases treated, treatment outcomes, and safety at our institution.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Acute adverse event rate
Key secondary outcomes
EPIC, EQ-5D-5L, 2-year late adverse event rate, 2-year biochemical relapse-free survival, 2-year overall survival, and 2-year prostate cancer-specific survival
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
(i) HYPOST is planned to be performed in our hospital for postoperative biochemical recurrence of prostate cancer.
(2) The patient has given consent for HYPOST.
(iii) The patient is able to lie in a supine position at rest.
Key exclusion criteria
(i) Previous history of radiotherapy to the pelvic region.
(ii) The patient has complications that contraindicate radiotherapy, such as active collagen disease, ulcerative colitis or Crohn's disease.
(iii) The patient had pN1 at the time of the prostatectomy.
(iv) The patient has a severe mental disorder or has difficulty in speaking or interviewing in Japanese.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shuji |
| Middle name | |
| Last name | Ohtsu |
Organization
Kyoto city hospital
Division name
Department of radiation oncology
Zip code
604-8845
Address
1-2 Mibuhigashitakadacho, Nakagyo Ward, Kyoto city, Kyoto, 604-8845, Japan
TEL
075-311-5311
so2.kch@gmail.com
Public contact
Name of contact person
| 1st name | Kiyonao |
| Middle name | |
| Last name | Nakamura |
Organization
Kyoto city hospital
Division name
Department of radiation oncology
Zip code
604-8845
Address
1-2 Mibuhigashitakadacho, Nakagyo Ward, Kyoto city, Kyoto, 604-8845, Japan
TEL
075-311-5311
Homepage URL
kiyonaka@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto city hospital
Institute
Department
Personal name
Shuji Ohtsu
Funding Source
Organization
None
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
Kyoto city hospital
Address
1-2 Mibuhigashitakadacho, Nakagyo Ward, Kyoto city, Kyoto, 604-8845, Japan
Tel
075-311-5311
kiyonaka@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
京都市立病院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 10 | 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
| 2025 | Year | 11 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2029 | Year | 11 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The aim of the study is to prospectively enrol patients undergoing HYPOST for postoperative biochemical recurrence of prostate cancer, to assess the details of their radiotherapy and post-treatment course, and to evaluate the efficacy and safety of this technique.
Management information
Registered date
| 2025 | Year | 11 | Month | 10 | Day |
Last modified on
| 2025 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067922
