4fr.CIRT for high risk-prostate cancer + dose measurement
Phase 1
Suspended
- Conditions
- Prostate cancerD011471
- Registration Number
- JPRN-jRCTs032190180
- Lead Sponsor
- Tsuji Hiroshi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Male
- Target Recruitment
- 40
Inclusion Criteria
1) biopsy-proven prostate cancer, 2) age >20 years, 3) T3a-T4N0M0 or PSA >= 20 ng/ml, GS>=8 according to MRI, CT and bone scintigram 4) Performance Status (ECOG), 0-1 5) Expected prognosis > 6 months 6) ability to understand and sign an informed consent form at each institution.
Exclusion Criteria
1) Other therapies except for hormonal therapy
2) Previous radiation therapy to the pelvis
3) Significant excess over the dose-constraints for risk organs
4) Castration-resistant prostate cancer
5) Previous treatment history of TUR-P
6) Active Double cancer
7) Untreatable infection or inflammatory disease in pelvis.
8) a serious medical or psychological condition precluding safe administration of treatment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse event
- Secondary Outcome Measures
Name Time Method Biochemical failure free survival rate, Overall survival rate, Non-clinical recurrence rate, Cancer specific survival rate, Evaluation of dose-volume histogram, evaluation of QOL, urethral dose evaluation by using of dosimeter