Vaccine Plus Booster Shots in Men With Prostate Cancer Undergoing Treatment With Radical Prostatectomy

Summary

Background: \- Some men with prostate cancer have their prostate glands removed. The cancer can still come back. Researchers want to know if receiving a vaccine before prostate removal surgery can lead to less recurrence. Objective: \- To see if a vaccine and booster shots given to men with prostate cancer before surgery changes the immune cells in the prostate gland. Eligibility: \- Men age 18 and older who have prostate cancer that has not spread, and who want to have their prostate glands removed as treatment. Design: * Participants will be screened by their regular cancer care. They may have a small piece of prostate removed. * Participants must practice effective birth control before and during the study treatment and for 1 month after the last vaccine booster. * Participants will have a medical history, physical exam, and blood and liver tests. They will be asked about how they perform daily activities. * Participants will have a magnetic resonance imaging (MRI) scan of the prostate. The scanner is a metal cylinder in a strong magnetic field. Participants will lie on a table that slides in and out of the scanner. * Participants will be injected with the vaccine, most likely in the leg. They will be injected with the vaccine booster 3 times over several weeks. * At each booster visit, participants will have a medical history, physical exam, and blood and liver tests. * Participants will have another MRI. Then they will have surgery to remove their prostate. * Participants will have 2 follow-up visits during the year after surgery. They will have a medical history, physical exam, and blood test.

Timeline

Start

2014-05-31

Primary completion

2017-07-28

Completion

2018-01-16

Publications

• Background DiPaola RS, Plante M, Kaufman H, Petrylak DP, Israeli R, Lattime E, Manson K, Schuetz T. A phase I trial of pox PSA vaccines (PROSTVAC-VF) with B7-1, ICAM-1, and LFA-3 co-stimulatory molecules (TRICOM) in patients with prostate cancer. J Transl Med. 2006 Jan 3;4:1. doi: 10.1186/1479-5876-4-1.
• Background Gulley JL, Heery CR, Madan RA, Walter BA, Merino MJ, Dahut WL, Tsang KY, Schlom J, Pinto PA. Phase I study of intraprostatic vaccine administration in men with locally recurrent or progressive prostate cancer. Cancer Immunol Immunother. 2013 Sep;62(9):1521-31. doi: 10.1007/s00262-013-1448-0. Epub 2013 Jul 9.
• Background Kantoff PW, Schuetz TJ, Blumenstein BA, Glode LM, Bilhartz DL, Wyand M, Manson K, Panicali DL, Laus R, Schlom J, Dahut WL, Arlen PM, Gulley JL, Godfrey WR. Overall survival analysis of a phase II randomized controlled trial of a Poxviral-based PSA-targeted immunotherapy in metastatic castration-resistant prostate cancer. J Clin Oncol. 2010 Mar 1;28(7):1099-105. doi: 10.1200/JCO.2009.25.0597. Epub 2010 Jan 25.
• Abdul Sater H, Marte JL, Donahue RN, Walter-Rodriguez B, Heery CR, Steinberg SM, Cordes LM, Chun G, Karzai F, Bilusic M, Harmon SA, Turkbey IB, Choyke PL, Schlom J, Dahut WL, Madan RA, Pinto PA, Gulley JL. Neoadjuvant PROSTVAC prior to radical prostatectomy enhances T-cell infiltration into the tumor immune microenvironment in men with prostate cancer. J Immunother Cancer. 2020 Mar;8(1):e000655. doi: 10.1136/jitc-2020-000655.

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