A clinical pilot study on the safety of highly-hypofractionated Dynamic WaveArc radiation therapy with simultaneous integrated boost for high-risk prostate cancer
- Conditions
- prostate cancer
- Registration Number
- JPRN-UMIN000033344
- Lead Sponsor
- Department of Radiation Oncology & Image-applied Therapy, Kyoto University Graduate School of Medicine
- Brief Summary
The incidents of acute adverse events of grade 2 or higher, the primary endpoints, were 26,9% and 7.7% for the urinary and rectum, respectively. No event of grade 3 or higher toxicity was observed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- Male
- Target Recruitment
- 26
Not provided
1) cT3a, iPSA >=30 ng/ml, and GS >= 4+4 2) active double cancer (i.e., overlapping cancer or asynchronous cancer within 5 years, except carcinoma in situ, intramucosal cancer, and other equivalent lesions) 3) Uncontrolled diabetes mellitus (HbA1c>+8.4%) 4) Severe coexisting diseases such as collagen disease, heart disease, respiratory disease and liver disease. 5) Psychotic disease 6) History of pelvic irradiation 7) History of pelvic surgery except for appendectomy and femoral herniation. 8) Surgical managements to the prostate 9) Chemotherapy to the prostate cancer 10) Inflammatory bowel diseases 11) Cases who are difficult to discontinue the administration of anticoagulant drugs. 12) Cases who are considered difficult to achieve dose constrain because of risk organs. 13) Cases with diffuse or large prostatic lesions. 14) Cases with significant metal artifact on pelvic CT images. 15) Cases who are difficult to achieve dose constrain at treatment planning.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidences of acute adverse events
- Secondary Outcome Measures
Name Time Method Incidences of late adverse events at 2 years PSA recurrence-free suravival rate at 2 years