University of Iowa starts Phase II trials with Ad/PSA vaccine


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:

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.

8 Responses

  1. Any info on the Phase I results of the procedure?

    Thanks

  2. “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 cancer cells.”

    Destruction of remaining cancer cells sounds like a cure, but they are certainly not aiming or hoping for that. IMHO the wording is misleading.

  3. As always, men who could be spared the debilitating side effects of “first line” treatment are left out of the trial. I guess the de facto rule is “Nobody threatens the surgeons’ and radiologists’ market.” All must suffer some whether they actually need to or not.

  4. Dear Dave:

    I vaguely remember seeing something about the Phase I study a while back … but such a study would have been limited to determining a safe dose of the combination therapy in man. Such studies are not structured to assess efficacy or safety over the long term.

  5. Dear Pawel:

    I actually find the wording used to be extremely precise. The study designers never mention the term “cure.” You are the one who is making that assumption. I would further point out that if this form of immunotherapy is able to “induce an anti-PSA immunity that will result in” the complete elimination of all remaining prostate cancer cells, then that surely would be a cure, wouldn’t it? How can you be so sure that the research team is “certainly not aiming or hoping for that” (at least in the trial of men with early progressive disease)?

  6. Tracy:

    Your cynicism is showing.

    :O)

  7. Tracy, your comment is right on. MSNBC did a story a few weeks ago on prostate cancer and their Medical Expert, a female doctor, in an “after” comment, voiced the same sentiment as you. Looking to start treatment and gathering information and this trial filling the need.

    I thank you and the doctor on MSNBC.

    Bill

  8. Anyone in this study that wants to share please post follow-up comment. I just reached the study minimum recurrent PSA of 0.2 and would like to join it soon.

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