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

Completed · Phase 2

Conditions studied: Prostate Cancer, Prostatic Neoplasms, Neoplasms, Prostate

In brief

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.

Key facts

Study ID

NCT02153918

Run by

National Cancer Institute (NCI)

People needed

27

Starts

2014-05-31

Expected to finish

2018-01-16

Last updated by the study team

2018-10-12

Who can join

Age: 18 and older, up to 100. Sex: male. Healthy volunteers: not accepted.

You may not qualify if…

• Prior splenectomy.
• The recombinant vaccinia vaccine should not be administered if the following apply to either recipients or, for at least 3 weeks after vaccination, their close household contacts (Close household contacts are those who share housing or have close physical contact):
• Persons with active or a history of eczema or other eczematoid skin disorders
• Those with other acute, chronic or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne or other open rashes or wounds) until condition resolves
• Pregnant or nursing women; children under 3 years of age
• Patients should have no evidence, as listed below, of being immunocompromised:
• HIV positivity due to the potential for decreased tolerance and risk for severe side effects.
• Hepatitis B or C positivity.
• Concurrent use of topical steroids (including steroid eye drops) or systemic steroids. This is to avoid immunosuppression which may lead to potential complications with vaccinia (priming vaccination). Nasal or inhaled steroid use is permitted.
• Patients with known allergy to eggs.
• Other serious intercurrent illness.
• Patients with a history of unstable or newly diagnosed angina pectoris, recent myocardial infarction (within 6 months of enrollment) or New York Heart Association class II-IV congestive heart failure.
• Patients with significant autoimmune disease that is active or potentially life threatening if activated.
• Patients with clinically significant cardiomyopathy requiring treatment.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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