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 |
Biochemical adaptive radiation therapy based on prostate-specific antigen response in salvage radiation therapy for postoperative biochemical failure of prostate cancer.
Biochemical Adaptive Salvage Radiation Therapy for biochemical failure after radical prostatectomy.
Biochemical adaptive radiation therapy based on prostate-specific antigen response in salvage radiation therapy for postoperative biochemical failure of prostate cancer.
Biochemical Adaptive Salvage Radiation Therapy for biochemical failure after radical prostatectomy.
Japan |
Prostate cancer
Urology |
Malignancy
NO
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.
Safety,Efficacy
5-year biochemical disease-free survival rate
Five years overall survival rate
Clinical recurrence style
The immediate nature period and close intestinal tract/urinary tract toxicity incidence
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Other |
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.
20 | years-old | <= |
85 | years-old | > |
Male
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
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
35
1st name | Toshiki |
Middle name | |
Last name | Ohno |
Kamagaya General Hospital
Radiation therapy
273-0121
929-6 Hatsutomi, Kamagaya-City Chiba
047-498-8111
chiken@kamagaya-hp.jp
1st name | Toshiki |
Middle name | |
Last name | Ohno |
Kamagaya General Hospital
Radiation therapy
273-0121
929-6 Hatsutomi, Kamagaya-City Chiba
047-498-8111
chiken@kamagaya-hp.jp
Kamagaya General Hospital
Kamagaya General Hospital
Self funding
The TOKUSHUKAI GROUP ETHICS COMMITTEE
1-3-1 Kudanminami,Chiyoda-ku,Tokyo
03-3263-4801
mirai-ec4@mirai-iryo.com
NO
2022 | Year | 05 | Month | 20 | Day |
Unpublished
Open public recruiting
2022 | Year | 03 | Month | 01 | Day |
2022 | Year | 05 | Month | 17 | Day |
2022 | Year | 05 | Month | 17 | Day |
2029 | Year | 07 | Month | 31 | Day |
2022 | Year | 04 | Month | 20 | Day |
2024 | Year | 03 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054210
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |