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Recurrent Prostate Cancer - Healing Genes
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Recurrent Prostate Cancer

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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


Phase 1 / 2

DESCRIPTION:
Houston Methodist Hospital is conducting a trial of an experimental treatment for recurrent 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 brachytherapy, or radioactive seed placement.

The investigational treatment will be delivered by injection into the prostate once during a brachytherapy injection, along with valocyclovir. Follow up continues for 5 years.


PATIENT MUST:

  • Be 0 years of age or older
  • Have a diagnosis of prostate cancer meeting clinical criteria
  • Have a life expectancy > 10 years

THE STUDY INVOLVES:

  1. Prescreening tests to confirm eligibility of the patient to participate.
  2. Antibiotic (Ciproflaxin) to take twice a day beginning the day before the procedure, and continuing for a total of 3 – 5 days.
  3. (Valtrex) valacyclovir taken three times a day for 14 days, beginning the day before the procedure, to be documented in a pill diary to record each dose of valacyclovir.
  4. Brachytherapy (radioactive seed placement) following the beginning of step (3).
  5. While still in the operating room, a small injection into the prostate of the investigatory drug.

LOCATIONS AND CONTACTS:
The study sites are at the Houston Methodist Hospital in Houston, TX. Map.
 
Contacts:
Brent Bell, PA-C  |  713-394-1105  |  [email protected]
Brian Butler, MD  |  [email protected]
 
SPONSOR INFORMATION:
The Methodist Hospital System
 
Or go online:
https://clinicaltrials.gov/ct2/show/NCT01913106

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