Phase II Study of Adenovirus/PSA Vaccine in Men With Recurrent Prostate Cancer After Local Therapy APP21 — APP21  

Recurrent Prostate Cancer Clinical Trial

Official title: Phase II Study of Adenovirus/PSA Vaccine in Men With Recurrent Prostate Cancer After Local Therapy

Status Completed

Clinical Trial Summary

The purpose of this study is to determine whether vaccination with the Ad/PSA vaccine will induce an anti-PSA immunity that will result in the destruction of the remaining prostate cancer cells.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Prostatic Neoplasms
• Recurrence
• Recurrent Prostate Cancer

• NCT number: NCT00583752
• Study type: Interventional
• Source: University of Iowa
• Status: Completed
• Phase: Phase 2
• Start date: December 2007
• Completion date: January 31, 2023