Phase I trial of hypofractionated intensity modulated radiotherapy in patients with low risk prostate cancer
Phase 1
- Conditions
- low risk prostate cancer
- Registration Number
- JPRN-UMIN000010236
- Lead Sponsor
- Kitasato univeristy school of medicine
- Brief Summary
ine patients were enrolled in each level. All patients were low or intermediate risk. Median durations of follow-up for patients at levels 1-3 were 48.9months, 42.6months, and 18.4months, respectively. Protocol treatment was completed for all patients. Although most toxicities were Grade 1, genitourinary toxicity was common compared to gastrointestinal toxicity. Three-year biochemical control rate was 90.3%.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 27
Inclusion Criteria
Not provided
Exclusion Criteria
*Other malignant tumors within 5 years except for carcinoma in situ *Psychiatric disease *Long-term administration of steroidal drugs *Poorly-controlled diabetis (HbA1c=6.5% or more) *Active infectious disease *Cerebral apoplexy within 6 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method maximum tolerated dose and recommended dose
- Secondary Outcome Measures
Name Time Method