Phase 1/2 clinical trial of image-guided hypofractionated intensity-modulated radiotherapy/volumetric modulated arc therapy for localized low- or intermediate-risk prostate cancer
- Conditions
- Prostate cancer
- Registration Number
- JPRN-UMIN000010295
- Lead Sponsor
- Tohoku University
- Brief Summary
A total of 12 patients were enrolled from March 2013 to April 2017 after institutional ethics committee approval. The study was terminated in November 2017 because the target number was not reached. No serious adverse events of Grade 3 or higher were observed in either the gastrointestinal tract or the urinary tract during the period. No biochemical recurrence was observed within the period.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 12
Not provided
1)Prior pelvic radiotherapy 2)Small cell carcinoma 3)cT3-4, exist of metastasis 4)Prior prostatectomy 5)Concurrent invasive cancers or collagen disease 6)PSA failure following hormonal therapy 7)If the attending physician judges the case inappropriate. 8)Gold allergy 9)Severe diabetes mellitus 10)Usage of anticoagulants/antiaggregant 11)Biochemical failure after hormonal therapy 12)Difficult to comply with dose constraints 13)IPSS>or=20
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 5-y biochemical relapse free survival
- Secondary Outcome Measures
Name Time Method 5-y distant metastasis free survival 5-y cause-specific survival 5-y overall survival Toxicity (acute and late)