Intraoperative photodynamic diagnosis of prostate cancer using fluorescence cystoscopy with 5-aminolevulinic acid (5-ALA) to detect the residual cancer in the surgical margin of radical prostatectomy
Phase 1
- Conditions
- ocalized prostate cancer
- Registration Number
- JPRN-UMIN000003251
- Lead Sponsor
- Department of Urology, Kochi Medical School
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 330
Inclusion Criteria
Not provided
Exclusion Criteria
Patient who has potential complication of local disorder and systematic absorption of 5-ALA such as solar photosensitivity and liver dysfunction
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Diagnostic accuracy: The levels in images of the 5-ALA-induced fluorescence were compared with the pathological results.
- Secondary Outcome Measures
Name Time Method Safety:The occurrence frequency and degree of adverse event were investigated through the procedures.