A Randomized Controlled Trial of Prostatak as Adjuvant to Up-Front Radiation Therapy for Localized Prostate Cancer
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.
* 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
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.
08/29/2014 04:02 AM