A multi-center randomized phase II study to evaluate the combination therapy of substitution of antiandrogens and tegafur-uracil for castration resistant prostate cancer
- Conditions
- castration resistant prostate cancer
- Registration Number
- JPRN-UMIN000009181
- Lead Sponsor
- Department of Urology, Institute of Health Biosciences, The University of Tokushima Graduate School
- Brief Summary
Fifty-two patients were enrolled in this study. Median age was 77 (47-92) years old. PSA response rate in group B (61.5%) tended to be higher than that in group A (34.6%) (p=0.0950). Group B (15.9 months) had significantly longer median time to PSA progression (TTP) than group A (6.4 months) (p=0.0137). In group B, patients with low TS (81.8%) tended to have higher PSA response rate than those with high TS (46.2%). In addition, among the patients with low TS, group B have shown significantly longer TTP than group A (p=0.0175). There were no severe AEs in both treatment groups.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 90
Not provided
1.past history of radiotherapy or prostatectomy 2.past history of allergic reactions 3.use phenytoin 4.contraindication of tegafur-uracil 5.active infection 6.serious complications 7.other cancer requiring treatment 8.judged inappropriate for the clinical trial by doctor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method