Phase II High Risk Prostate Cancer Trial Using Gene & Androgen Deprivation Therapies, Radiotherapy, & Surgery

This is a prospective phase II study to assess the efficacy and toxicity of HSV-tk+ valacyclovir gene therapy in combination with androgen deprivation therapy, brachytherapy, external beam radiotherapy, and prostatectomy in previously untreated high-risk prostate cancer.

Trial Details

NCT ID
NCT03541928
Phase
PHASE2
Sponsor
The Methodist Hospital Research Institute
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • HSV-Tk
  • Valacyclovir
  • Bicalutamide
  • Leuprolide Acetate
  • Brachytherapy, External beam radiotherapy
  • Radical prostatectomy
Locations (sample)
  • Houston, Texas, United States|29.76328,-95.36327

Key Eligibility Criteria

  • All patients must have biopsy proven adenocarcinoma of the prostate
  • Patients in should have at least one or more of the following characteristics PSA\>20, Gleason score 8-10, Primary Gleason pattern 5, \>4 cores wit…
  • No prior surgical, hormonal, or radiotherapy prostate treatment.
  • ECOG performance status 0-1

For full eligibility, visit ClinicalTrials.gov.

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