prostae cancer prostate cancer, oncolytic, genetically engineered virus, virus therapy, gene therapy, cancer treatment, herpes simplex virus type1
Conditions
Interventions
Intratumoral inoculation of G47delta (1 x 10 pfu) given on day 1, day 8 and every 4 weeks thereafter, up to 6 times.
Sponsors
Hiroshi Fukuahra
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Patients who meet all of the following conditions are targeted. 1) Patients who had prostate cancer that was newly diagnosed 2) Patients willing to undergo long-term androgen depletion therapy 3) WHO Performance Status: 0-1 patients 4) Patients with metastases confirmed by imaging before 12 weeks of enrollment 5) Patients who have not started androgen depletion therapy before 12 weeks of enrollment 6) Age: Men over 20 years old 7) Patients who have received sufficient explanation before participating in this study, and who have obtained the patient's voluntary written consent after sufficient understanding 8) Patients with the following data within 14 days before registration Number of neutrophils 1,500 / mm3 or more Platelet count 10x104 / mm3 or higher AST (GOT) 75 U / L or less (2.5 times the standard value) ALT (GPT) 105 U / L or less (2.5 times the standard value) Total bilirubin value 2.25 mg / dL or less (1.5 times the standard value) Serum potassium level 3.5 mmol / L or higher eGFR 30 ml / min / 1.73 mm2 or more
Exclusion criteria
Exclusion criteria: Those who meet any of the following conditions are not eligible. 1) Patients who have undergone radical treatment for prostate cancer 2) Patients with metastases to the brain or pia mater 3) Patients receiving chemotherapy for prostate cancer 4) Patients who have received androgen depletion therapy before 12 weeks of enrollment 5) Patients with concurrent active double cancer at enrollment 6) Patients who have undergone surgery for benign prostatic hyperplasia such as TURP within the past 4 weeks 7) Patients participating in clinical trials / clinical studies of unapproved drugs within 30 days prior to participation in this study 8) Patients with a history of virus therapy 9) HIV positive or pre-existing patients 10) Patients with active herpesvirus infection 11) Patients with alcohol or other drug addiction 12) Patients with active and uncontrolled infections 13) Patients with uncontrolled or severe heart failure / diabetes / hypertension / interstitial pneumonia / renal failure / autoimmune disease 14) Patients with allergies to anti-HSV drug (acyclovir) 15) In addition, patients who are judged by the investigator or the investigator to be inappropriate for conducting this study safely
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year failure-free survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Statistical analysis of 1-year failure-free survival rate, overall survival, failure-free survival, adverse event rate, severe adverse event rate | — |
Contacts
Public ContactFukuhara Hiroshi
Kyorin University School of Medicine
Outcome results
None listed