Phase II High Risk Prostate Cancer Trial Using Gene & Androgen Deprivation Therapies, Radiotherapy, & Surgery
Phase II Study Evaluating HSV-tk + Valacyclovir Gene Therapy in Combination With Androgen Deprivation Therapy, Brachytherapy, External Beam Radiotherapy, and Prostatectomy for High-Risk Prostate Cancer
Houston Methodist Hospital is conducting a trial of an experimental treatment for high risk prostate cancer that uses a virus to deliver a cancer suicide gene called HSV-tK to their tumor. In combination with valocyclovir medicine, this gene may cause the cancer to self-detonate by incorporating a molecule that stops their replication. This experimental treatment will be delivered along with standard radiation and chemotherapy.
The investigational treatment will be delivered by injection into the prostate twice in a month’s time period along with valocyclovir. Additionally, FDA-approved hormone therapy drugs for prostate cancer will be given. Two months post this treatment, radiation treatment will be delivered and a radical prostatectomy performed. Follow up with involve PSA testing and questionnaires for up to 5 years.
- Be 18 years of age or older
- Have a diagnosis of prostate cancer meeting high risk clinical criteria
- Have a life expectancy ≥ 12 weeks
- Be willing to use birth control, if sexually active
THE STUDY INVOLVES:
- Prescreening tests to confirm eligibility of the patient to participate.
- At day 1 and day 30 of treatment, the viral gene therapy will be injected to the prostate, and Valocyclovir administered for 14 days after each injection.
- Hormone therapies bicalutamide (Casodex) and leuprolide acetate (Lupron) will be given for a period of several weeks.
- 60 days into treatment, a radiation in form of brachytherapy, and external beam radiotherapy will be performed.
- 2 to 3 weeks post step (4), a radical prostatectomy will be performed.
- Follow up with involve PSA testing and questionnaires for up to 5 years.
LOCATIONS AND CONTACTS:
The study sites are at the Houston Methodist Hospital in Houston, TX. Map.
The Methodist Hospital System
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