Clinical Trial: Prospective Observational Study of Hypofractionated Postprostatectomy Salvage Radiation Therapy (HYPOST) (Japan)

Tokyo, Nov. 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059723) titled 'Prospective Observational Study of Hypofractionated Postprostatectomy Salvage Radiation Therapy (HYPOST)' on Nov. 10.

Study Type: Observational

Primary Sponsor: Institute - Kyoto city hospital

Condition: Condition - Postoperative biochemical recurrence of prostate cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: 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

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 Size - 20

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067922

Disclaimer: Curated by HT Syndication.