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Title:
A Randomized Controlled Trial of Prostatak as Adjuvant to Up-Front Radiation Therapy for Localized Prostate Cancer
Protocol Number:
J1192
Phase:
Phase III
Physician:
Theodore DeWeese
Purpose:
The overall objective for this study is to determine if adjuvant therapy with an adenoviral vector (ProstAtak) improves the clinical outcome of radiation therapy for newly diagnosed prostate cancer. Primary: disease free survival Secondary: PSA nadir, freedom from biochemical failure, prostate cancer specific survival, overall survival, quality of life assessment, immune stimulation.
Eligibility:
* histologically confirmed adenocarcinoma of the prostate *has to meet at least one of the three intermediate risk criteria OR only one single high risk factor *must be planning and medically able to undergo standard prostate-only external beam radiation therapy and able to tolerate multiple transrectal ultrasound guided injections *18 years or age or older *ECOG 0-2 *must agree to have prostate biopsy two years after end of RT *Laboratory criteria must be met
Treatment:
Patients will be randomzied to test or control at a 2:1 ratio. Patients on the Test arms will receive three courses of ProstAtak each consisiting of AdV-tk injection + oral valacyclovir. Patients in the Control Arm will receive corresponding courses of placebo injection + oral valacyclovir. AdV-tk or placebo injection will be delivered to the prostate via TRUS-guided injection as follows: 1. 1st injection is at least 15 days and not more than 8 weeks before starting radiation. 2. 2nd injection is 0-3 days before initiation of radiation therapy and at least 15 days after injection #1. 3. 3rd injection is 15-22 days after injection #2. The produg, valacyclovir, will be administed at a fixed dose for 14 days after each AdV-tk or placebo injection starting the day after the injection.
Population:
Adult
Last Update
07/29/2014 04:02 AM
 

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