A research team at the University of Iowa is seeking patients to enroll in Phase II clinical trials of a new form of vaccine immunotherapeutic to treat men with recurrent prostate cancer.
The trials are based on the use of a virus-based vaccine in which the gene for prostate specific antigen (PSA) has been placed into a common cold virus — an adenovirus (Ad) — to produce the so-called Ad/PSA vaccine product.
These two trials have been designed to determine whether vaccination with the Ad/PSA vaccine will induce anti-PSA immunity leading to destruction of prostate cancer cells. Currently available information suggests that this form of therapy will not be associated with any of the types of major side effect that are common to hormonal or chemotherapeutic treatment for progressive prostate cancer.
The detailed information about the two clinical trials is available on the ClinicalTrials.gov web site. There are two different studies being carried out:
- The first is for men with recurrent disease (indicated by a rising PSA) after standard first-line treatment for apparently localized prostate cancer.
- The second is for men with castrate-resistant prostate cancer (CRPC) who have progressive disease (with or without evidence of metastatic spread of the cancer) after treatment with standard forms of hormonal therapy.
In each trial, patients will initially be screened for eligibility to participate in the trial. If accepted, they will receive treatment with three doses of the vaccine at 30-day intervals, followed by regular visits to the University of Iowa Hospitals and Clinics to for a variety of tests to assess their immune status and the status of their recurrent disease.
In the first of these two trials, men will be randomized to receive 14 days of hormone therapy prior to the first injection of the vaccine or to no hormone therapy.
For more detailed information, please feel able to to contact the clinical trial coordinator (Pamela Zehr, RN) by phone (319-353-8914) or by e-mail.