Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2026-03-02 @ 5:47 AM
Study NCT ID:
NCT02326805
Status:
COMPLETED
Last Update Posted:
2023-07-19
First Post:
2014-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PROSTVAC (PSA-TRICOM) in Preventing Disease Progression in Patients With Localized Prostate Cancer Undergoing Active Surveillance
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
Phase II Randomized, Placebo-Controlled Trial of PROSTVAC (PSA-TRICOM) in Patients With Clinically Localized Prostate Cancer Undergoing Active Surveillance
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the effect of rilimogene-galvacirepvec (PROSTVAC) on the 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.
II. To determine the effect of PROSTVAC on the change in CD4+ positive cells in the stroma adjacent to tumor and within the malignant portion of the prostate biopsies.
SECONDARY OBJECTIVES:
I. To assess the effect of PROSTVAC on PD-L1 positive cells in the stroma adjacent to tumor and within the malignant portion of the prostate biopsies.
II. To assess the correlation between the change in CD8+ and the change in PSA. III. To assess the effect of PROSTVAC on CD8+, CD4+, and PD-L1 positive cells in the benign portion of the prostate biopsies.
IV. To assess the effect of PROSTVAC on the change in PSA. V. To assess the effect of PROSTVAC on tumor grade (Gleason score). VI. To assess the effect of PROSTVAC on tumor extent (percent of positive random biopsy cores).
VII. To compare the proportion of men on the two study arms with no cancer on post-intervention biopsy.
VIII. To assess the effect of PROSTVAC on the size of the dominant lesion on magnetic resonance imaging (MRI) (largest histopathologically confirmed lesion) in the subgroup of patients with MRIs pre and postintervention.
IX. To assess the effect of PROSTVAC on circulating 15-Mer PSA-specific, MUC-1 and Brachyury-specific T cells.
X. To assess the effect of PROSTVAC on soluble antibodies to tumor-associated antigens.
XI. To assess the immunologic effects of PROSTVAC in prostate tissue using multiplex immunofluorescence.
XII. To assess the safety and feasibility of PROSTVAC in the active surveillance population.
XIII. To assess the effect of PROSTVAC on lower urinary tract symptoms (LUTS) in the active surveillance population.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive rilimogene-galvacirepvec subcutaneously (SC) at baseline and on days 14, 28, 56, 84, 112, and 140.
ARM II: Patients receive placebo SC at baseline and on days 14, 28, 56, 84, 112, and 140.
After completion of study treatment, patients are followed up for 30 days and then at 6 months.
I. To determine the effect of rilimogene-galvacirepvec (PROSTVAC) on the 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.
II. To determine the effect of PROSTVAC on the change in CD4+ positive cells in the stroma adjacent to tumor and within the malignant portion of the prostate biopsies.
SECONDARY OBJECTIVES:
I. To assess the effect of PROSTVAC on PD-L1 positive cells in the stroma adjacent to tumor and within the malignant portion of the prostate biopsies.
II. To assess the correlation between the change in CD8+ and the change in PSA. III. To assess the effect of PROSTVAC on CD8+, CD4+, and PD-L1 positive cells in the benign portion of the prostate biopsies.
IV. To assess the effect of PROSTVAC on the change in PSA. V. To assess the effect of PROSTVAC on tumor grade (Gleason score). VI. To assess the effect of PROSTVAC on tumor extent (percent of positive random biopsy cores).
VII. To compare the proportion of men on the two study arms with no cancer on post-intervention biopsy.
VIII. To assess the effect of PROSTVAC on the size of the dominant lesion on magnetic resonance imaging (MRI) (largest histopathologically confirmed lesion) in the subgroup of patients with MRIs pre and postintervention.
IX. To assess the effect of PROSTVAC on circulating 15-Mer PSA-specific, MUC-1 and Brachyury-specific T cells.
X. To assess the effect of PROSTVAC on soluble antibodies to tumor-associated antigens.
XI. To assess the immunologic effects of PROSTVAC in prostate tissue using multiplex immunofluorescence.
XII. To assess the safety and feasibility of PROSTVAC in the active surveillance population.
XIII. To assess the effect of PROSTVAC on lower urinary tract symptoms (LUTS) in the active surveillance population.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive rilimogene-galvacirepvec subcutaneously (SC) at baseline and on days 14, 28, 56, 84, 112, and 140.
ARM II: Patients receive placebo SC at baseline and on days 14, 28, 56, 84, 112, and 140.
After completion of study treatment, patients are followed up for 30 days and then at 6 months.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2014-02556 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| AZ027 | None | None | View | |
| HHSN2612012000311 | None | None | View | |
| N01-CN-2012-00031 | None | None | View | |
| 1410547210 | OTHER | Banner University Medical Center - Tucson | View | |
| UAZ2014-03-01 | OTHER | DCP | View | |
| N01CN00031 | NIH | None | https://reporter.nih.gov/quic… | View |
| P30CA023074 | NIH | None | https://reporter.nih.gov/quic… | View |