A clinical study on the safety of hypo-fractionated stereotactic intensity-modulated radiation therapy for prostate cancer
Not Applicable
- Conditions
- Prostate cancer
- Registration Number
- JPRN-UMIN000012057
- Lead Sponsor
- Department of Radiation Oncology & Image-applied Therapy, Kyoto University Graduate School of Medicine
- Brief Summary
o grade 3 or higher acute toxicity was observed. With a minimum follow-up period of 2 years, no grade 2 or higher late toxicity was observed and the 2-year biochemical recurrence-free survival rate was 95.8%.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 24
Inclusion Criteria
Not provided
Exclusion Criteria
1) Active double cancer 2) Uncontrolled diabetes mellitus (HbA1c>+8.4%) 3) Severe coexisting diseases such as collagen disease, heart disease, respiratory disease and liver disease. 4) Psychotic disease 5) History of pelvic irradiation 6) History of pelvic surgery except for appendectomy and femoral herniation. 7) Surgical managements to the prostate 8) Chemotherapy to the prostate cancer 9) Inflammatory bowel diseases 10) Cases who are difficult to discontinue the administration of anticoagulant drugs.
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