A Phase II Study of Prostvac Immunotherapy to Treat Biochemical Recurrent Prostate Cancer

Full Title

NCI #16-C-0035: Prostvac in Patients with Biochemical Recurrent Prostate Cancer

Purpose

When a man’s prostate-specific antigen (PSA) level starts to rise after local therapy for prostate cancer (such as surgery, radiation, or cryotherapy), it is called “biochemical recurrent prostate cancer.” The standard treatment for these men is hormonal therapy or monitoring (surveillance). In this study, researchers are evaluating the safety and effectiveness of a prostate cancer vaccine called Prostvac in men with biochemical recurrent prostate cancer.

Prostvac works by teaching the immune system to find and kill prostate cancer cells. Participants in this study will be randomly assigned to receive Prostvac for six months or to undergo surveillance for six months. The men who first have surveillance will then be able to receive six months of Prostvac after their surveillance period has ended. Prostvac is given as a subcutaneous (under the skin) injection.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have rising PSA (with a PSA doubling time of 5-15 months) after local therapy for prostate cancer.
  • Patients may not have previously received chemotherapy, and they may not have had immunotherapy in the three years before the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Susan Slovin at 646-422-4470.

Protocol

17-348

Phase

II

Investigator

Co-Investigators