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High Risk Prostate Cancer

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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

Phase 1 / 2


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


  1. Prescreening tests to confirm eligibility of the patient to participate.
  2. 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.
  3. Hormone therapies bicalutamide (Casodex) and leuprolide acetate (Lupron) will be given for a period of several weeks.
  4. 60 days into treatment, a radiation in form of brachytherapy, and external beam radiotherapy will be performed.
  5. 2 to 3 weeks post step (4), a radical prostatectomy will be performed.
  6. Follow up with involve PSA testing and questionnaires for up to 5 years.


The study sites are at the Houston Methodist Hospital in Houston, TX. Map.


Emily Hsiao, Ph.D.  |  713-383-5115  |  [email protected]
Christine O’Reilly  |  713-394-1107  |  [email protected]



The Methodist Hospital System


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