HSV-tk + Valacyclovir Therapy in Combination With Brachytherapy for Recurrent Prostate Cancer

Recruiting Phase 1 Phase 2 Interventional Study
Prostatic Neoplasms
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
Sex
Male
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
25 (estimated)
Sponsor
The Methodist Hospital Research Institute · Other
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About This Trial

The purpose of this study is to conduct a Phase I - II clinical trial to extend preclinical studies involving in situ HSV-tk + Valacyclovir gene therapy in combination with brachytherapy for recurrent prostate cancer. This will provide a novel therapeutic approach to prostate cancer and hopefully impact on the development of metastatic disease and the control of preexisting metastasis.

Trial Locations
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Eligibility Criteria
INCLUSION CRITERIA: * biopsy-proven local recurrence of prostate cancer without metastatic disease after the hormone therapy at least 2 year after the completion of definitive radiation therapy * Zubrod performance status 0-1 * WBC ≥ 4,000/μl, platelets ≥ 100,000/μl * hemoglobin ≥ 8.5 mg/dl * norma…
Contacts

Brent Bell, PA-C

713-394-1105

bcbell@houstonmethodist.org

CONTACT

Brian Butler, MD

ebutler@houstonmethodist.org

CONTACT