Prospective observational safety and efficacy study of the carbon ion radiotherapy in 16 fractions for localized prostate cancer
Phase 2
- Conditions
- Prostate cancer
- Registration Number
- JPRN-UMIN000016646
- Lead Sponsor
- working group of heavy ion therapy for genitourinary tumor, Gunma university
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 280
Inclusion Criteria
Not provided
Exclusion Criteria
1) Past radiotherapy to the pelvic region 2) Past physical treatment of the prostate (TUR-P, HIFU, etc.) 3) Past chemotherapy within 4 weeks 4) Life expectancy is less than 6 months 5) Multiple malignancies within 5 years 6) Androgen deprivation therapy period will be over than 8 months at the end of carbon ion radiotherapy 7) Castration refractory 8) Denial for the protocol androgen deprivation therapy 9) Steroid and anti-androgen therapy for other disease 10) Severe comorbidity 11) Judged inappropriate for this study by physicians
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 5-yr biochemical relapse free survival
- Secondary Outcome Measures
Name Time Method 1) 5-yr overall survival 2) 5-yr cause specific survival 3) 5-yr local control 4) acute toxicity 5) late toxicity 6) QO