Hypofractionated radiotherapy for low and intermediate-risk prostate cancer using robot-tracking stereotactic radiotherapy -phase I/II clinical trial
Phase 1
- Conditions
- prostate cancer
- Registration Number
- JPRN-UMIN000014328
- Lead Sponsor
- Osaka University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- Male
- Target Recruitment
- 75
Inclusion Criteria
Not provided
Exclusion Criteria
1) Active double cancer 2) Uncontrollable DM 3) Impossible to stop anticoagulate drugs 4) Severe brain disease 5) Collagen disease 6) Previous pelvic surgery or radiotherapy 7) Previous TUR-P 8) Severe BPH or dysuria 9) Disagree to implant of metallic marker 10) Hormone therapy > 1 year 11) Castration-resistant prostate cancer 12) PSA >20 13) Physician-rated contraindication
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ratio of 2-year late adverse events (genitourinary and gaastrointestinal Grade 2 or more)
- Secondary Outcome Measures
Name Time Method 2-year biochemical control rate, QOL questionnaire (EPIC + SF-8), dosimetry (dose distribution etc. in radiation physics)