Castration resistant prostate cancer
Conditions
Interventions
The administration of an oncolytic HSV-1 G47delta
Sponsors
The University of Tokyo Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: In this single-armed phase I study, patients with prostate cancer that had not received prostatectomy and recurred after hormonal therapy are registered. Both of those with and without prior record of chemotherapy, and both of those with and without remote metastases are included.
Exclusion criteria
Exclusion criteria: -Administration of other clinical study drugs within 30 days of G47delta administration -Known HIV seropositivity -Current diagnosis of any medical or psychological condition that might interfere with the subject's ability to participate -Blood test results outside protocol specified limits -Evidence of active herpes infection -Current diagnosis of any active malignant tumor -Active uncontrolled infection that precludes surgery -History of alcohol or other drug abuse -Allergy to anti-HSV drug (acyclovir) -Administration of any anticancer drugs within 30 days of G47delta administration -Administration of any anti-androgen drugs within 30 days of G47delta administration -Conditions considered inadequate for the subject to be enrolled in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety -Spectrum and frequency of adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy -Change in PSA levels | — |
Countries
Japan
Contacts
Public ContactHiroshi Fukuhara
The University of Tokyo Hospital Translational Research Center
Outcome results
None listed