Prostatic Acid Phosphatase (PAP) Vaccine in Patients With Prostate Cancer

Completed · Phase 1

Conditions studied: Prostate Cancer

In brief

The investigators are trying to find new methods to treat prostate cancer. The approach they investigators are taking is to try to enhance patients own immune response against the cancer. In this study the investigators will be testing the safety of a vaccine that may be able to help the body fight prostate cancer.

Key facts

Study ID

NCT00582140

Run by

University of Wisconsin, Madison

People needed

22

Starts

2005-03-01

Expected to finish

2008-08-01

Last updated by the study team

2019-11-19

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Must have histologic diagnosis of adenocarcinoma of the prostate
• Must have completed local therapy by surgery and/or ablative radiation therapy at least 2 months prior to entry.
• Must have clinical stage D0 disease defined by the following: In patients treated by surgery, serum PSA values must be > 2 ng/ml by two measurements at least two weeks apart. In patients treated with ablative radiation therapy, three consecutive increases in serum PSA must be documented, with at least a one month interval between values with the finalPSA > 2ng/ml.
• Prior history of a second malignancy is allowed if treated with curative intent disease free for > 5 years.
• Karnofsky performance score of > 70

You may not qualify if…

• No evidence of immunosuppression or have been treated with immunosuppressive therapy, such as chemotherapy, chronic treatment dose corticosteroids (greater than the equivalent of 10 mg prednisone per day), or radiation therapy to >30% of the bone marrow, within 6 months of the first vaccination.
• Must not be on concurrent androgen ablative (hormonal) therapy, or must have completed this therapy at least one month prior to study entry.
• Must not have demonstrated PSA progression during any prior hormonal therapy or chemotherapy.
• Must not have known evidence of bone metastases or non-regional lymph node involvement (stage D2 disease) as determined by bone scan or CT scan. -Must not have been treated previously with another investigational anti- tumor vaccine.

Where it is running

• University of Wisconsin — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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