Phase II Study of Adenovirus/PSA Vaccine in Men With Hormone - Refractory Prostate Cancer
Subjects in this trial will be eligible if they have recent evidence of hormone refractory
disease (D3) and either (a) have a positive bone scan or a positive CT scan (with obvious
soft tissue metastasis or lymph nodes >1 cm), with a PSA doubling time of >/= 12 months, a
total PSA of < 5 mg/ml, and are asymptomatic; or (b) have a negative bone scan with any PSA
doubling time, are asymptomatic, and are not a candidate for chemotherapy.
This is a virus vaccine in which the gene for prostate specific antigen (PSA) has been
placed into a common cold virus termed adenovirus (Ad) to produce this Ad/PSA product. 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
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.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
PSA doubling-time response
David M Lubaroff, PhD
University of Iowa
United States: Food and Drug Administration
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