Clinical trial · Interventional
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
NCT01913106CI-TRIAL-00022811recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HSV-tk +Valacyclovir in Combination with Brachytherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HSV-tk + Valacyclovir and Brachytherapy
- description
- You will be given an antibiotic (Ciproflaxin) to take twice a day beginning the day before the procedure, and continuing for a total of 3 - 5 days. You will also be given 4 pills called (Valtrex) valacyclovir to take three times a day for 14 days, beginning the day before the procedure. You will be given a pill diary in which you will record each dose of valacyclovir that you take. You will receive brachytherapy (radioactive seed placement) the day after you begin taking your pills. After the radioactive seeds are placed, while you are still in the operating room, you will receive an injection into your prostate of 1 or 2 ml (one-fifth or two-fifths of a teaspoon) of a solution of the vector carrying the gene.
- interventionNames
- Drug: HSV-tk +Valacyclovir in Combination with Brachytherapy
Primary outcomes (1)
- measure
- 1. Safety based on standard laboratory and clinical adverse event monitoring
- timeFrame
- 5-year biochemical disease free survival rate
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.