At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 44 enrolled

Drug / intervention

Ad5-yCD/mutTKSR39rep-ADP +1 morebiological

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00583492

NCT00583492Phase 2Completed

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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

Henry Ford Health System·interventional·Posted Dec 31, 2007·Updated Mar 17, 2016

In Brief

A Phase 2 clinical trial evaluating Ad5-yCD/mutTKSR39rep-ADP and IMRT for Prostate Cancer. Completed, enrolled 44 participants across 2 sites.

Detailed Summary

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 Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsProstate Cancer

CountriesUnited States

Collaborators--

Timeline

Phase 2CompletedFinished

20082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartDec 2007

First PostedDec 2007

Primary CompletionSep 2013

TodayJul 2026

First PostedDec 31, 2007

Enrollment StartDec 1, 2007

Primary CompletionSep 1, 2013

TodayJul 2, 2026

Enrollment to primary: 5.8 yearsPosted 18.5 years ago

Interventions

Ad5-yCD/mutTKSR39rep-ADPbiological

Ad5-yCD/mutTKSR39rep-ADP (1 x 10\^12 vp) on day 1 Plus Radiation - 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy Plus 2 week course (weekdays only) of 5-FC and vGCV prodrug therapy

IMRTradiation

40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy