Gene therapy combined 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
PHASE1; PHASE2 · The Methodist Hospital Research Institute · NCT01913106
This study is testing a new gene therapy combined with targeted radiation to see if it can help men with prostate cancer that has come back after previous treatments.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Sex | Male |
| Sponsor | The Methodist Hospital Research Institute (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT01913106 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and efficacy of a novel gene therapy using HSV-tk in combination with brachytherapy for patients with locally recurrent prostate cancer who have not responded to prior radiation treatments. The study will involve administering a replication-defective adenovirus vector to deliver the HSV-tk gene, which, when activated by the antiviral drug ganciclovir, can induce cell death in cancerous cells. The trial is designed to assess how well this combination therapy can control tumor growth and potentially prevent the spread of cancer. It is a Phase I/II study, indicating an early exploration of safety and initial efficacy.
Who should consider this trial
Good fit: Ideal candidates for this study are men with biopsy-proven local recurrence of prostate cancer after hormone therapy and definitive radiation therapy, without metastatic disease.
Not a fit: Patients with active untreated infections, major medical or psychiatric illnesses, or those currently undergoing other experimental cancer treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new effective treatment option for patients with recurrent prostate cancer who currently have limited therapeutic alternatives.
How similar studies have performed: While gene therapy approaches have been explored in other contexts, this specific combination of HSV-tk gene therapy with brachytherapy for recurrent prostate cancer is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Houston, Texas
- Houston Methodist — Houston, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Edward B Butler, MD — The Methodist Hospital Research Institute
- Study coordinator: Brent Bell, PA-C
- Email: bcbell@houstonmethodist.org
- Phone: 713-394-1105
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostatic Neoplasms