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PROSTVAC (PSA-TRICOM) in Preventing Disease Progression in Patients With Localized Prostate Cancer Undergoing Active Surveillance

NCT02326805 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2023-07-19

Study results available
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Summary

This randomized phase II trial studies how well PROSTVAC (prostate-specific antigen \[PSA\]-TRICOM) works in preventing disease progression in patients with prostate cancer undergoing active surveillance. Vaccines made from a person's tumor cells may help the body build an effective immune response to kill tumor cells that express PSA.

Conditions

  • Stage I Prostate Adenocarcinoma AJCC v7
  • Stage II Prostate Adenocarcinoma AJCC v7

Interventions

OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Placebo Administration

Given SC

BIOLOGICAL

Rilimogene Galvacirepvec

Given SC

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • John K Parsons · The University of Arizona Medical Center-University Campus

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-03
Primary Completion
2018-11-30
Completion
2022-07-20

Countries

  • United States

Study Locations

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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 NCT02326805 on ClinicalTrials.gov