A multi-institutional clinical trial of carbon-ion radiotherapy for localized high-risk prostate cancer
Phase 2
- Conditions
- Prostate Cancer
- Registration Number
- JPRN-UMIN000025921
- Lead Sponsor
- ational Institutes for Quantum and Radiological Sciences and Technology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- Male
- Target Recruitment
- 156
Inclusion Criteria
Not provided
Exclusion Criteria
1) Existence of any treatment, excluding androgen deprivation therapy for prostate cancer. 2) Past history of radiotherapy which interferes with the study treatment. 3) Existence of other active malignancies (any co-existing malignancies and history of malignancy within 2 years). in-situ lesions which are concluded to be cured are not considered as such. 4) Uncontrolled infection and inflammatory disease within the irradiation field of the study treatment. 5) Psychologically and/or medically unfit for trial decided by an attending physician.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 5-year biochemical recurrence free survival
- Secondary Outcome Measures
Name Time Method late toxicity (gastrointestinal, genitourinary), 5-year overall survival, 5-year cause specific survival, cost effectiveness, quality of life