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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02326805
Recruitment Status : Active, not recruiting
First Posted : December 30, 2014
Results First Posted : November 2, 2021
Last Update Posted : November 2, 2021
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Stage I Prostate Adenocarcinoma AJCC v7
Stage II Prostate Adenocarcinoma AJCC v7
Interventions Other: Laboratory Biomarker Analysis
Other: Placebo Administration
Biological: Rilimogene Galvacirepvec
Enrollment 154
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I (Rilimogene-galvacirepvec) Arm II (Placebo)
Hide Arm/Group Description

Patients receive rilimogene-galvacirepvec SC at baseline and on days 14, 28, 56, 84, 112, and 140.

Laboratory Biomarker Analysis: Correlative studies

Rilimogene Galvacirepvec: Given SC

Patients receive placebo SC at baseline and on days 14, 28, 56, 84, 112, and 140.

Laboratory Biomarker Analysis: Correlative studies

Placebo Administration: Given SC

Period Title: Overall Study
Started 106 48
Completed 103 47
Not Completed 3 1
Arm/Group Title Arm I (Rilimogene-galvacirepvec) Arm II (Placebo) Total
Hide Arm/Group Description

Patients receive rilimogene-galvacirepvec SC at baseline and on days 14, 28, 56, 84, 112, and 140.

Laboratory Biomarker Analysis: Correlative studies

Rilimogene Galvacirepvec: Given SC

Patients receive placebo SC at baseline and on days 14, 28, 56, 84, 112, and 140.

Laboratory Biomarker Analysis: Correlative studies

Placebo Administration: Given SC

Total of all reporting groups
Overall Number of Baseline Participants 106 48 154
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 106 participants 48 participants 154 participants
65  (7) 64  (8) 64  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 48 participants 154 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
106
 100.0%
48
 100.0%
154
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 48 participants 154 participants
Hispanic or Latino
4
   3.8%
1
   2.1%
5
   3.2%
Not Hispanic or Latino
98
  92.5%
45
  93.8%
143
  92.9%
Unknown or Not Reported
4
   3.8%
2
   4.2%
6
   3.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 48 participants 154 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
3
   2.8%
0
   0.0%
3
   1.9%
Native Hawaiian or Other Pacific Islander
1
   0.9%
0
   0.0%
1
   0.6%
Black or African American
7
   6.6%
5
  10.4%
12
   7.8%
White
91
  85.8%
43
  89.6%
134
  87.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
4
   3.8%
0
   0.0%
4
   2.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 106 participants 48 participants 154 participants
106 48 154
1.Primary Outcome
Title Change in CD8+ Positive Cells in the Stroma Adjacent to Tumor and Within the Malignant Portion of the Prostate Biopsies
Hide Description change (pre to post-intervention) in CD8+ positive cells in the stroma adjacent to tumor and within the malignant portion of the prostate biopsies.
Time Frame Baseline to up to 14 days after the last dose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with tumor present in tissue sections from both the pre and post-intervention biopsies
Arm/Group Title Arm I (Rilimogene-galvacirepvec) Arm II (Placebo)
Hide Arm/Group Description:

Patients receive rilimogene-galvacirepvec SC at baseline and on days 14, 28, 56, 84, 112, and 140.

Laboratory Biomarker Analysis: Correlative studies

Rilimogene Galvacirepvec: Given SC

Patients receive placebo SC at baseline and on days 14, 28, 56, 84, 112, and 140.

Laboratory Biomarker Analysis: Correlative studies

Placebo Administration: Given SC

Overall Number of Participants Analyzed 72 28
Mean (Standard Deviation)
Unit of Measure: number of positive cells per mm^2
12.2  (151.4) -6.9  (154)
2.Primary Outcome
Title Change in CD4+ Positive Cells in the Stroma Adjacent to Tumor and Within the Malignant Portion of the Prostate Biopsies
Hide Description change (pre to post-intervention) in CD4+ positive cells in the stroma adjacent to tumor and within the malignant portion of the prostate biopsies.
Time Frame Baseline to up to 14 days after the last dose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with tumor present on the tissue sections from both the pre and post-intervention biopsies were included in the analysis
Arm/Group Title Arm I (Rilimogene-galvacirepvec) Arm II (Placebo)
Hide Arm/Group Description:

Patients receive rilimogene-galvacirepvec SC at baseline and on days 14, 28, 56, 84, 112, and 140.

Laboratory Biomarker Analysis: Correlative studies

Rilimogene Galvacirepvec: Given SC

Patients receive placebo SC at baseline and on days 14, 28, 56, 84, 112, and 140.

Laboratory Biomarker Analysis: Correlative studies

Placebo Administration: Given SC

Overall Number of Participants Analyzed 69 28
Mean (Standard Deviation)
Unit of Measure: number of positive cells per mm^2
4.6  (166.7) 5.8  (261.1)
3.Secondary Outcome
Title Change in PD-L1 Positive Cells in the Stroma Adjacent to Tumor and Within the Malignant Portion of the Prostate Biopsies
Hide Description A two-sided two-sample t test at a significance level of 5% will be performed to compare the rilimogene-galvacirepvec and placebo groups. A subgroup analysis will be performed to compare the change in PD-L1 positive cells between study groups in specimens collected by targeted biopsy.
Time Frame Baseline to 6 months post-intervention
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Change in Prostate-specific Antigen (PSA)
Hide Description Pearson correlation coefficient will be derived to evaluate the correlation between the change in CD8+ and the change in PSA for participants treated with rilimogene-galvacirepvec.
Time Frame Baseline to 6 months post-intervention
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Change in CD8+ Positive Cells in the Benign Portion of the Prostate Biopsies
Hide Description A two-sided two-sample t test at a significance level of 5% will be performed to compare the rilimogene-galvacirepvec and placebo groups.
Time Frame Baseline to up to 14 days after the last dose
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Change in CD4+ Positive Cells in the Benign Portion of the Prostate Biopsies
Hide Description A two-sided two-sample t test at a significance level of 5% will be performed to compare the rilimogene-galvacirepvec and placebo groups.
Time Frame Baseline to up to 14 days after the last dose
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Change in PD-L1 Positive Cells in the Benign Portion of the Prostate Biopsies
Hide Description A two-sided two-sample t test at a significance level of 5% will be performed to compare the rilimogene-galvacirepvec and placebo groups.
Time Frame Baseline to up to 14 days after the last dose
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Tumor Grade Progression
Hide Description Assessed by Gleason score. A two-sided two-sample t test at a significance level of 5% will be performed to compare the rilimogene-galvacirepvec and placebo groups. Fisher's exact test will be performed to compare the proportion of patients with no cancer on the post-intervention biopsy and the proportion of men with an increase in Gleason score to >= 4+3 from baseline to post-intervention biopsy between the two groups. Will be evaluated in the subgroup of patients in whom magnetic resonance imaging (MRI)-targeted biopsies were obtained pre- and post-intervention
Time Frame Baseline to up to 30 days after the last dose
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Change in Tumor Extent
Hide Description A two-sided two-sample t test at a significance level of 5% will be performed to compare the rilimogene-galvacirepvec and placebo groups. Fisher's exact test will be performed to compare the change in tumor extent and the proportion of men with an increase in Gleason score to >/= 4+3 between the two groups.
Time Frame Baseline to up to 30 days after the last dose
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Proportion of Men With no Cancer in the Post-intervention Biopsy Between Participants Treated With Rilimogene-galvacirepvec and Those Treated With Placebo
Hide Description This analysis will utilize all biopsy data, i.e., from random and target biopsy cores. Fisher's exact test will be performed to compare the proportion of patients with no cancer on the post-intervention biopsy and the proportion of men with an increase in Gleason score to >= 4+3 between the two groups.
Time Frame Up to 14 days after the last dose
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Size of Dominant MRI Lesion
Hide Description A two-sided two-sample t test at a significance level of 5% will be performed to compare the rilimogene-galvacirepvec and placebo groups. Fisher's exact test will be performed to compare the size of dominant MRI lesion and the proportion of men with an increase in Gleason score to >/= 4+3 between the two groups.
Time Frame Up to 6 months post-intervention
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Incidence of Adverse Events Identified Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Hide Description Descriptive statistics of the type and frequency of all adverse events will be generated, including 95% confidence intervals. For each type of the adverse events, a Fisher's exact test will be performed to compare the frequency of the adverse event between the two groups.
Time Frame Up to 30 days after the last dose
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Change in Circulating 15-Mer PSA-specific T Cells
Hide Description A two-sided two-sample t test at a significance level of 5% will be performed to compare the rilimogene-galvacirepvec and placebo groups.
Time Frame Baseline to up to 14 days after the last dose
Outcome Measure Data Not Reported
14.Secondary Outcome
Title Change in Soluble Antibodies to Tumor-associated Antigens
Hide Description A two-sided two-sample t test at a significance level of 5% will be performed to compare the rilimogene-galvacirepvec and placebo groups.
Time Frame Baseline to up to 14 days after the last dose
Outcome Measure Data Not Reported
15.Secondary Outcome
Title Immunologic Effects of Rilimogene-galvacirepvec on the Target Organ Using Multiplex Immunofluorescence
Hide Description A two-sided two-sample t test at a significance level of 5% will be performed to compare the rilimogene-galvacirepvec and placebo groups.
Time Frame Up to 14 days after the last dose
Outcome Measure Data Not Reported
16.Secondary Outcome
Title Change in International Prostate Symptom Score
Hide Description A two-sided two-sample t test at a significance level of 5% will be performed to compare the rilimogene-galvacirepvec and placebo groups.
Time Frame Baseline to up to 6 months post-intervention
Outcome Measure Data Not Reported
Time Frame 30 days after the last study dose was given
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I (Rilimogene-galvacirepvec) Arm II (Placebo)
Hide Arm/Group Description

Patients receive rilimogene-galvacirepvec SC at baseline and on days 14, 28, 56, 84, 112, and 140.

Laboratory Biomarker Analysis: Correlative studies

Rilimogene Galvacirepvec: Given SC

Patients receive placebo SC at baseline and on days 14, 28, 56, 84, 112, and 140.

Laboratory Biomarker Analysis: Correlative studies

Placebo Administration: Given SC

All-Cause Mortality
Arm I (Rilimogene-galvacirepvec) Arm II (Placebo)
Affected / at Risk (%) Affected / at Risk (%)
Total   1/106 (0.94%)   0/48 (0.00%) 
Hide Serious Adverse Events
Arm I (Rilimogene-galvacirepvec) Arm II (Placebo)
Affected / at Risk (%) Affected / at Risk (%)
Total   1/106 (0.94%)   0/48 (0.00%) 
Injury, poisoning and procedural complications     
Fall   1/106 (0.94%)  0/48 (0.00%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I (Rilimogene-galvacirepvec) Arm II (Placebo)
Affected / at Risk (%) Affected / at Risk (%)
Total   103/106 (97.17%)   48/48 (100.00%) 
Gastrointestinal disorders     
Diarrhea   10/106 (9.43%)  6/48 (12.50%) 
Nausea   9/106 (8.49%)  2/48 (4.17%) 
General disorders     
Fatigue   43/106 (40.57%)  14/48 (29.17%) 
Fever   17/106 (16.04%)  6/48 (12.50%) 
Injection site reaction   95/106 (89.62%)  45/48 (93.75%) 
Hepatobiliary disorders     
Flu like syndromes   63/106 (59.43%)  30/48 (62.50%) 
Infections and infestations     
Upper respiratory infection   10/106 (9.43%)  4/48 (8.33%) 
Injury, poisoning and procedural complications     
Bruising   6/106 (5.66%)  3/48 (6.25%) 
Investigations     
White blood cell decreased   1/106 (0.94%)  4/48 (8.33%) 
Musculoskeletal and connective tissue disorders     
Back pain   7/106 (6.60%)  4/48 (8.33%) 
Myalgia   8/106 (7.55%)  2/48 (4.17%) 
Nervous system disorders     
Dizziness   10/106 (9.43%)  0/48 (0.00%) 
Headache   23/106 (21.70%)  9/48 (18.75%) 
Renal and urinary disorders     
Renal and urinary disorders - others   2/106 (1.89%)  4/48 (8.33%) 
Respiratory, thoracic and mediastinal disorders     
Sore throat   5/106 (4.72%)  3/48 (6.25%) 
Skin and subcutaneous tissue disorders     
Rash maculo-papular   2/106 (1.89%)  4/48 (8.33%) 
Skin and subcutaneous tissue disorders - other   3/106 (2.83%)  4/48 (8.33%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sherry Chow, PhD
Organization: University of Arizona
Phone: 520-626-3358
EMail: schow@azcc.arizona.edu
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02326805    
Other Study ID Numbers: NCI-2014-02556
NCI-2014-02556 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
AZ027
HHSN2612012000311
N01-CN-2012-00031
1410547210 ( Other Identifier: Banner University Medical Center - Tucson )
UAZ2014-03-01 ( Other Identifier: DCP )
N01CN00031 ( U.S. NIH Grant/Contract )
P30CA023074 ( U.S. NIH Grant/Contract )
First Submitted: December 24, 2014
First Posted: December 30, 2014
Results First Submitted: September 9, 2021
Results First Posted: November 2, 2021
Last Update Posted: November 2, 2021