Randomized Trial of Suicide Gene Therapy and Prostate Cancer

ClinicalTrials.gov ID: NCT00583492

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Official title

A Randomized, Controlled Trial of Replication-Competent Adenovirus-Mediated Suicide Gene Therapy in Combination With IMRT Versus IMRT Alone for the Treatment of Newly-Diagnosed Prostate Cancer With an Intermediate Risk Profile

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a randomized, controlled trial that will test the hypothesis that replication-competent adenovirus-mediated suicide gene therapy in combination with 80 Gy intensity modulated radiotherapy (IRMT)will improve freedom from failure (FFF) relative to 80 Gy IMRT alone in patients with newly-diagnosed prostate cancer with an intermediate-risk profile.

Study identification

NCT ID: NCT00583492
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: Henry Ford Health System; Other
Enrollment: 44 participants

Conditions and interventions

Conditions

Prostate Cancer

Interventions

Ad5-yCD/mutTKSR39rep-ADP Biological
IMRT Radiation

Biological · Radiation

Eligibility (public fields only)

Age range: 18 Years and older
Sex: Male
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Dec 2007 (Type not available)
Primary completion: Sep 2013 (Actual)
Completion: Sep 2013 (Actual)
Last update posted: Mar 17, 2016

2007 – 2013

United States locations

U.S. sites: 2
U.S. states: 2
U.S. cities: 2

Facility	City	State	ZIP	Site status
Johns Hopkins University School of Medicine	Baltimore	Maryland	21231	—
Henry Ford Health System	Detroit	Michigan	48202	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00583492, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Mar 17, 2016 · Synced Nov 15, 2026