HSV-tk + Valacyclovir Therapy in Combination With Brachytherapy for Recurrent Prostate Cancer

• Status: Recruiting
• Trial end date: 2028-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to conduct a Phase I - II clinical trial to extend preclinical studies involving in situ HSV-tk + Valacyclovir gene therapy in combination with brachytherapy for recurrent prostate cancer. This will provide a novel therapeutic approach to prostate cancer and hopefully impact on the development of metastatic disease and the control of preexisting metastasis.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Methodist Hospital Research Institute; The Methodist Hospital System
• Treatments: Acyclovir; Valacyclovir

Criteria

INCLUSION CRITERIA:

• biopsy-proven local recurrence of prostate cancer without metastatic disease after the hormone therapy at least 2 year after the completion of definitive radiation therapy

• Zubrod performance status 0-1

• WBC ≥ 4,000/μl, platelets ≥ 100,000/μl

• hemoglobin ≥ 8.5 mg/dl

• normal partial thromboplastin time and prothrombin time

• bilirubin < 1.5 mg/dl, and AST and alanine aminotransferase < 2.5 times the upper limit of normal

• Serum creatinine ≤ 1.6 mg/dl

• Must undergo pre-treatment evaluation of tumor extent and tumor measurement

• Nutritional and general physical condition must be considered compatible with the proposed radio-therapeutic treatment

• Not on any other experimental therapeutic cancer treatment

• No active untreated infection

• No major medical or psychiatric illness

• International Prostate Symptom Score (IPSS) less than 15

• Signed study-specific consent form prior to study entry

• Prostate volume less than 50 cc

• PSA > 10ng/ml within the past 3 months may enter study

EXCLUSION CRITERIA:

• Symptomatic metastasis disease

• Patients with a life expectancy < 10 years

• Patients on corticosteroids or any immunosuppressive drugs.

• HIV + patients

• Patients with acute infections (viral, bacterial, or fungal infections requiring therapy)

• Patients with cirrhosis.

• Patients with collagen vascular diseases

• International Prostate Symptom Score (IPSS) greater than 15

• Prostate volume greater than 50 cc

• Second active cancer except cutaneous cancer

• Patients with history of allergies to valacyclovir, acyclovier or who cannot take oral pills