A clinical study of adenovirus mediated Reduced Expression in Immortalized Cells/Dickkopf-3(REIC/Dkk-3)gene therapy for prostate cancer
Phase 1
- Conditions
- prostate cancer
- Registration Number
- JPRN-UMIN000004929
- Lead Sponsor
- Okayama University hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- Male
- Target Recruitment
- 24
Inclusion Criteria
Not provided
Exclusion Criteria
1 Uncontrolled infectious disease 2 Patient who received clinical trial 3 Concomitant malingant disese. Interval of NED is exceptional 4 Patient who had a histor of withdrawal from this trial 5 Patient who are considered by investigator as unappropriate for this trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Tolerability: Performance Status CBC (including platelets, fibrinogen, SGPT, lactic dehydrogenase) Adverse events (AEs) Physical examination (PE) Vital signs (VS) Clinical laboratory values
- Secondary Outcome Measures
Name Time Method Post-radical prostatectomy evaluation PSA lymphocyte analysis using FCM(3days, 1,2,4 week)