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

Recruiting Phase 2 Interventional Study
High-risk Prostate Cancer Prostate Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Male
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
The Methodist Hospital Research Institute · Other
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About This Trial

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 Locations
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Eligibility Criteria
Inclusion 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 with Gleason 8-10, and Clinical stage T3a-T4. * No prior surgic…
Contacts

Emily Hsiao, Ph.D.

713-383-5115

khsiao@houstonmethodist.org

CONTACT

Christine O'Reilly

713-394-1107

coreilly@houstonmethodist.org

CONTACT