UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047536 |
|---|---|
| Receipt number | R000054210 |
| Scientific Title | Biochemical adaptive radiation therapy based on prostate-specific antigen response in salvage radiation therapy for postoperative biochemical failure of prostate cancer. |
| Date of disclosure of the study information | 2022/05/20 |
| Last modified on | 2024/03/25 16:13:46 |
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Basic information
Public title
Biochemical adaptive radiation therapy based on prostate-specific antigen response in salvage radiation therapy for postoperative biochemical failure of prostate cancer.
Acronym
Biochemical Adaptive Salvage Radiation Therapy for biochemical failure after radical prostatectomy.
Scientific Title
Biochemical adaptive radiation therapy based on prostate-specific antigen response in salvage radiation therapy for postoperative biochemical failure of prostate cancer.
Scientific Title:Acronym
Biochemical Adaptive Salvage Radiation Therapy for biochemical failure after radical prostatectomy.
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We hypothesize that pelvic lymph node prophylactic irradiation of PSA-nonresponders during treatment with PBRT will provide optimal salvage radiotherapy avoiding overtreatment, and we will evaluate the safety and efficacy of this treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
5-year biochemical disease-free survival rate
Key secondary outcomes
Five years overall survival rate
Clinical recurrence style
The immediate nature period and close intestinal tract/urinary tract toxicity incidence
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
All patients will be prescribed 68 Gy to the prostate bed.
Patients are defined as responders and non-responders based on the change in PSA before radiotherapy and on the day of 46 Gy irradiation.
The responders will be completed at 68 Gy without field modification. The non-responders will be given extended field(pelvic wall radiation therapy)prescribed by 50 Gy.
Pre-treatment preparation period 1-14 days
Radiotherapy period 2 to 3 months
Post-treatment observation period 60 months.
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
| 85 | years-old | > |
Gender
Male
Key inclusion criteria
1 Biochemical failure of a cT1~3bN0~1M0, radical prostatectomy +/- pelvic lymph node dissection.
2 Adenocarcinoma or Tubular adenocarcinoma
3 Performance status0-1
4 I cannot detect a macroscopic lesion in an examination for image at the time of a recurrence diagnosis
5 The thing that is obtained a document agreement by a patient on participating of this study
Key exclusion criteria
1.Prior exposure to any anti-cancer drug and/or hormonal agents.
2.History of pelvic irradiation.
3.Active overlap cancer
4.I have various disorders to impair inspection, treatment
5.In addition, the patient who was judged to be inappropriate as an object by the judgment of the doctor
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Toshiki |
| Middle name | |
| Last name | Ohno |
Organization
Kamagaya General Hospital
Division name
Radiation therapy
Zip code
273-0121
Address
929-6 Hatsutomi, Kamagaya-City Chiba
TEL
047-498-8111
chiken@kamagaya-hp.jp
Public contact
Name of contact person
| 1st name | Toshiki |
| Middle name | |
| Last name | Ohno |
Organization
Kamagaya General Hospital
Division name
Radiation therapy
Zip code
273-0121
Address
929-6 Hatsutomi, Kamagaya-City Chiba
TEL
047-498-8111
Homepage URL
chiken@kamagaya-hp.jp
Sponsor or person
Institute
Kamagaya General Hospital
Institute
Department
Personal name
Funding Source
Organization
Kamagaya General Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The TOKUSHUKAI GROUP ETHICS COMMITTEE
Address
1-3-1 Kudanminami,Chiyoda-ku,Tokyo
Tel
03-3263-4801
mirai-ec4@mirai-iryo.com
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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 05 | Month | 20 | 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
| 2022 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 17 | Day |
Last follow-up date
| 2029 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 04 | Month | 20 | Day |
Last modified on
| 2024 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054210
