A Phase II Randomized, Double Blind, Controlled Study to Evaluate the Safety and Efficacy of PROSTVAC®-VF/TRICOM™ in Combination With GM-CSF in Patients With Androgen-Independent Adenocarcinoma of the Prostate

Inclusion Criteria

- Male patients > 18 years of age who have been vaccinated against smallpox;

- Histological confirmation of adenocarcinoma of the prostate with evidence of
metastatic disease including either of the following: Lymph node metastasis
measurable by CT and/or Bone metastasis evaluable by bone scan;

- Despite hormone therapy, there is evidence of two consecutive increases in PSA
(Prostate Specific Antigen);

- Gleason Score of 7 or lower at initial diagnosis.

Please note that there are additional eligibility criteria that you must meet to qualify.

If you do qualify to participate, study personnel will explain the trial in detail and
answer any questions you may have. You can then decide whether or not you wish to
participate. If you do not qualify for the trial, study personnel will explain the
reasons.