Eligibility, male only, with Stage I Prostate Adenocarcinoma AJCC v7 or Stage II Prostate Adenocarcinoma AJCC v7. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in CD8+ Positive Cells in the Stroma Adjacent to Tumor and Within the Malignant Portion of the Prostate BiopsiesPrimary· Baseline to up to 14 days after the last dose
change (from pre to post-intervention) in CD8+ positive cells in the stroma adjacent to tumor and within the malignant portion of the prostate biopsies.
Group
Value
95% CI
Arm I (Rilimogene-galvacirepvec)
12.2
± 151.4
Arm II (Placebo)
-6.9
± 154
Change in CD4+ Positive Cells in the Stroma Adjacent to Tumor and Within the Malignant Portion of the Prostate BiopsiesPrimary· Baseline to up to 14 days after the last dose
change (from pre to post-intervention) in CD4+ positive cells in the stroma adjacent to tumor and within the malignant portion of the prostate biopsies.
Group
Value
95% CI
Arm I (Rilimogene-galvacirepvec)
4.6
± 166.7
Arm II (Placebo)
5.8
± 261.1
Change in Prostate-specific Antigen (PSA)Secondary· Baseline to 6 months post-intervention
Change (from baseline to 6 months post-intervention) in prostate-specific antigen (PSA)
Group
Value
95% CI
Arm I (Rilimogene-galvacirepvec)
0.26
± 2.36
Arm II (Placebo)
-0.66
± 3.49
Change in CD8+ Positive Cells in the Benign Portion of the Prostate BiopsiesSecondary· Baseline to up to 14 days after the last dose
Change (from pre to post-intervention) in CD8+ positive cells in the benign portion of the prostate biopsies
Group
Value
95% CI
Arm I (Rilimogene-galvacirepvec)
7.22
± 202.94
Arm II (Placebo)
45.25
± 198.25
Change in CD4+ Positive Cells in the Benign Portion of the Prostate BiopsiesSecondary· Baseline to up to 14 days after the last dose
Change (from pre to post-intervention) in CD4+ positive cells in the benign portion of the prostate biopsies
Group
Value
95% CI
Arm I (Rilimogene-galvacirepvec)
73.41
± 287.74
Arm II (Placebo)
-19.75
± 206.59
Tumor Grade ProgressionSecondary· Baseline to up to 14 days after the last dose
Assessed by the proportion of men with an increase in Gleason score to \>= 4+3 from baseline to post-intervention biopsy. The Gleason score is determined by adding the two most common grades. The Gleason score usually ranges from 6 to 10. Higher numbers indicate a faster growing cancer that is more likely to spread.
Group
Value
95% CI
Arm I (Rilimogene-galvacirepvec)
8
Arm II (Placebo)
6
Change in Tumor ExtentSecondary· Baseline to up to 14 days after the last dose
Assessed by change (from pre to post-intervention) in percent positive random cores
Group
Value
95% CI
Arm I (Rilimogene-galvacirepvec)
-1.7
± 16.1
Arm II (Placebo)
1.6
± 15.2
Proportion of Men With no Cancer in the Post-intervention BiopsySecondary· Up to 14 days after the last dose
Assessed by the proportion of patients with no cancer on the post-intervention biopsy
Group
Value
95% CI
Arm I (Rilimogene-galvacirepvec)
25
Arm II (Placebo)
8
Change in International Prostate Symptom ScoreSecondary· Baseline to up to 6 months post-intervention
Change (from baseline to 6 months post-intervention) in International Prostate Symptom Score (IPSS). The IPSS score ranges from 0-35. Higher scores mean a worse symptom.
Group
Value
95% CI
Arm I (Rilimogene-galvacirepvec)
-0.12
± 4.67
Arm II (Placebo)
0.87
± 3.57
Adverse events — posted to ClinicalTrials.gov
Time frame: 30 days after the last study dose was given.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 19 July 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02326805.