prostate cancer
Conditions
Interventions
1.0x10E10 virus particle
1.0x10E11 virus particle
1.0x10E12 virus particle
Sponsors
Okayama University hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: A)Hormone refractory prostate cancer Patient with non metastatica case. PSA rising after definitive hormonal therapy Patinet with metastatic case Patients who are diagnosed asmetastatic disease at the time of initial diagnosis. Patient who become metastatic disease after radical prostatectomy in spite of hormonal therapy. B)Newly diagnosed localized prostate cancer who will receive prostatectomy Patient with high risk of reccurrence after operation
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tolerability: Performance Status CBC (including platelets, fibrinogen, SGPT, lactic dehydrogenase) Adverse events (AEs) Physical examination (PE) Vital signs (VS) Clinical laboratory values | — |
Secondary
| Measure | Time frame |
|---|---|
| Post-radical prostatectomy evaluation PSA lymphocyte analysis using FCM(3days, 1,2,4 week) | — |
Countries
Japan,North America
Contacts
Public ContactYasutomo Nasu
Okayama University Department of Urology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Outcome results
None listed