This trial is active, not recruiting.

Condition hormone refractory prostate cancer
Treatment adenovirus/psa vaccine
Phase phase 2
Sponsor University of Iowa
Collaborator Department of Defense
Start date December 2007
End date July 2016
Trial size 66 participants
Trial identifier NCT00583024, 200605710, PC061667/2


This investigational study involves treatment with an Ad/PSA vaccine for men with prostate cancer who present with evidence of hormone refractory metastatic disease.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
adenovirus/psa vaccine
1x10E8 pfu in Gelfoam subcutaneously on days 0, 30, 60

Primary Outcomes

PSA doubling-time response
time frame: 18 months

Secondary Outcomes

Serum PSA levels and Immune response
time frame: 18 months

Eligibility Criteria

Male participants from 18 years up to 90 years old.

Inclusion criteria: - Men with prostate cancer who present with evidence of hormone refractory disease (D3). - Men with a positive bone scan or a positive CT scan (with obvious soft tissue metastasis or lymph nodes >1 cm), a PSA doubling time of >/= 6 months, and a total PSA of <10 ng/ml, and asymptomatic OR men with a negative bone scan and a negative CT scan with any PSA doubling time and asymptomatic. - Scans must be obtained within 6 weeks of initiation of treatment. - Written informed consent. - Age >/= 18 years. - Required laboratory values (obtained within 2 weeks of initiation of treatment) - Serum creatinine /= 1800 per mm3, platelets >/= 100,000 per mm3, WBC >/= 3700, and lymphocytes >590. - Adequate hepatocellular function: AST <3x upper limit of normal and total bilirubin <1.5 mg/dl (unless bilirubin elevation is consistent with Gilbert's syndrome). - Castrate levels of testosterone of

Additional Information

Official title Phase II Study of Adenovirus/PSA Vaccine in Men With Hormone - Refractory Prostate Cancer
Principal investigator David M Lubaroff, PhD
Description 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 cancer cells. 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by University of Iowa.