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HSV-tk + Valacyclovir Therapy in Combination With Brachytherapy for Recurrent Prostate Cancer
Phase I-II Study HSV-tk + Valacyclovir Therapy in Combination With Brachytherapy for Recurrent Prostate Cancer With or Without Metastatic Disease
Who can join
All ages · Men
Full eligibility 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
About the study
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.
What is being tested
- HSV-tk +Valacyclovir in Combination with Brachytherapy (drug)
Sponsor: The Methodist Hospital Research Institute · Participants: 25 · Started: 2007-06
Contact the study team
- Brent Bell, PA-C · Phone: 713-394-1105
Official record on ClinicalTrials.gov — NCT01913106
Locations in the U.S.
| Texas | Houston Methodist, Houston |
Conditions
From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.