Phase II study of hypofractionated postoperative intensity-modulated radiotherapy for prostate cancer in adjuvant and salvage settings
Phase 2
- Conditions
- Prostate cancer
- Registration Number
- JPRN-UMIN000035287
- Lead Sponsor
- The University of Tokyo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- Male
- Target Recruitment
- 55
Inclusion Criteria
Not provided
Exclusion Criteria
a) patient refused to participate in this trial b) distant metastasis is recognized c) past history of irradiation to pelvis d) participation in another clinical trial which may affect this trial e) judged as inappropriate to participation by investigators
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The incidence of CTCAE grade 2-4 genitourinary and gastrointestinal toxicity during the initiation of radiotherapy and 90 days from the end of radiotherapy. Toxicities will be graded using CTCAE version 5.0. Biochemical recurrence-free survival
- Secondary Outcome Measures
Name Time Method Overall survival The incidence of toxicity during the initiation of radiotherapy and 90 days from the end of radiotherapy The incidence of toxicity during the follow-up period after 90 days from the end of radiotherapy Quality of life during the all follow-up period.