Oncolytic herpes simplex virus type I (HSV-1) virus therapy using G47delta for patients with prostate cancer

Hiroshi Fukuahra0 个研究点目标入组 30 人开始时间: 2022年2月14日最近更新: 2024年4月1日

适应症

试验速览

暂无简介。

•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 IU / L or less (1.5 times the standard value)
•Serum potassium level 3.5 mmol / mL or higher
•GFR 30 ml / min / 1.73 mm2 or more

•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

发起方

Hiroshi Fukuahra