Phase II Study of Adenovirus/PSA Vaccine in Men With Recurrent Prostate Cancer After Local Therapy
Subjects will be randomized to Arm A (vaccine only) or Arm B (androgen deprivation therapy
plus vaccine). On Arm A, subjects can begin the three vaccinations immediately. On Arm B,
subjects will be started on androgen deprivation therapy (ADT) 14 days prior to beginning
the vaccinations.
Subjects will be vaccinated three times, each injection administered at 30-day intervals.
Based upon our earlier clinical trial, the vaccine is considered safe and should not induce
any major side effects. The investigators hope that vaccination with this PSA virus will
cause the body to produce immunity to the PSA and that immunity will destroy any cell that
produces PSA. Since the only cells left in the body that produce PSA will be the cancer
cells, the investigators propose that the vaccination and ensuing anti-PSA immunity will
kill the prostate cancer cells. Importantly, this treatment should not cause any major side
effects as would treatment with anti-cancer drugs.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
PSA doubling-time response
18 months
Yes
David M Lubaroff, PhD
Principal Investigator
University of Iowa
United States: Food and Drug Administration
200605706
NCT00583752
December 2007
July 2014
Name | Location |
---|---|
Holden Comprehensive Cancer Center | Iowa City, Iowa 52242-1009 |