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Prostvac in Patients With Biochemically Recurrent Prostate Cancer

NCT02649439 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2022-11-14

Study results available
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Summary

Background:

Some people who have been treated for prostate cancer still have high prostate-specific antigen (PSA) levels. This may indicate cancer. These people have non-metastatic castration sensitive prostate cancer (nmCSPC) or biochemical recurrent prostate cancer. Researchers think the immune system can be taught to fight and kill cancer cells. They think an immunotherapy vaccine called prostvac could help reduce PSA levels in people with this type of prostate cancer.

Objective:

To test if prostvac can decrease tumor growth rate as measured by PSA compared to getting surveillance alone.

Eligibility:

Men ages 18 or older who have nmCSPC or biochemical recurrent prostate cancer

Design:

Participants will be screened with:

Medical history

Physical exam

Blood and urine tests

Bone scan

Computed tomography (CT) scan, or magnetic resonance imaging (MRI) and positron emission tomography (PET) scan: They lie in a machine that takes pictures of the body.

Electrocardiogram: Soft electrodes are stuck to the skin to record heart signals.

Participants will be part of 1 of 2 arms: Arm A will get prostvac for 6 months. Arm B will have surveillance for 6 months followed by prostvac for 6 months.

During the prostvac period, participants will get prostvac as a shot under the skin on weeks 1, 3, and 5, and then monthly for a total of 5 months.

Participants will have follow-up visits at least every month until they recover from prostvac side effects or their cancer worsens. Visits may include repeats of screening tests.

Participants will be followed for up to 15 years. They will have a physical exam every year for the first 5 years. They will have phone calls once a year.

Conditions

Interventions

BIOLOGICAL

PROSTVAC -V

Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus

BIOLOGICAL

PROSTVAC-F

Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Ravi A Madan, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-22
Primary Completion
2019-03-28
Completion
2022-10-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02649439 on ClinicalTrials.gov