A Prospective Clinical Trial of Carbon-ion Radiotherapy for Patients with Prostate Cancer of Clinical Stage T1c-T3N0M0
Phase 2
- Conditions
- Patients with Prostate Cancer of Clinical Stage T1c-T3N0M0
- Registration Number
- JPRN-UMIN000027640
- Lead Sponsor
- Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
- Brief Summary
This study confirmed safety and efficacy comparable to those reported from prior facilities.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 78
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patient with past history of radiotherapy for the targeted lesion 2) Patient with castration-resistant prostate cancer 3) Patient with active double cancer 4) Patient with active and intractable infection in the targeted lesion. 5) Patient with metal devices in the lesion which will cause adverse risk by carbon-ion radiotherapy 6) Patient eligible for Advanced Medicine Program B (Sen-shin Iryo B) 7) Other medical or psychological condition which is unsuitable for carbon-ion therapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Biochemical progression-free survival at 5 years
- Secondary Outcome Measures
Name Time Method 1) Overall survival 2) Disease-specific survival 3) Event-free survival 4) Early and late-phase adverse event rate