This trial is active, not recruiting.

Condition prostate cancer
Treatment prostvac®-vf/tricom™
Phase phase 2
Sponsor Therion Biologics Corporation
Start date November 2003
Trial size 120 participants
Trial identifier NCT00078585, NCT00081120, TBC-PRO-002


PROSTVAC-VF is an investigational cancer vaccine. The vaccine is based on the theory that the immune system can be taught to fight cancer by directing the immune system to attack specific targets found on cancer cells. These targets are called Tumor Associated Antigens, or TAA's. This trial will help determine if this vaccine can help fight cancer.

This multi-center, double-blind, randomized, empty vector-controlled trial is designed to evaluate the safety and efficacy of PROSTVAC-VF/TRICOM co-administered with GM-CSF versus the empty viral vector co-administered with placebo in the treatment of patients with androgen-independent prostate cancer (AIPC).

All patients will be required to sign an informed consent prior to the performance of any on-study procedures. Patients will be screened for eligibility within 14 days prior to vaccine administration. Patients who meet all inclusion and exclusion criteria will be centrally randomized into the study and will receive a unique patient identification number and a blinded treatment assignment. The ratio of active treatment to empty vector control (placebo) is 2:1.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Masking double-blind
Primary purpose treatment

Eligibility Criteria

Male participants at least 18 years old.

- 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.

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in July 2005.
Information provided to ClinicalTrials.gov by Therion Biologics Corporation.