Trial Outcomes & Findings for PROSTVAC (PSA-TRICOM) in Preventing Disease Progression in Patients With Localized Prostate Cancer Undergoing Active Surveillance (NCT NCT02326805)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

154 participants

Primary outcome timeframe

Baseline to up to 14 days after the last dose

Results posted on

2023-07-19

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I (Rilimogene-galvacirepvec) 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	Arm II (Placebo) 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 Study STARTED	106	48
Overall Study COMPLETED	103	47
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Rilimogene-galvacirepvec) n=106 Participants 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	Arm II (Placebo) n=48 Participants 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 n=154 Participants Total of all reporting groups
Age, Continuous	65 years STANDARD_DEVIATION 7 • n=93 Participants	64 years STANDARD_DEVIATION 8 • n=4 Participants	64 years STANDARD_DEVIATION 8 • n=27 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Male	106 Participants n=93 Participants	48 Participants n=4 Participants	154 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=93 Participants	1 Participants n=4 Participants	5 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	98 Participants n=93 Participants	45 Participants n=4 Participants	143 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=93 Participants	2 Participants n=4 Participants	6 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	3 Participants n=93 Participants	0 Participants n=4 Participants	3 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Black or African American	7 Participants n=93 Participants	5 Participants n=4 Participants	12 Participants n=27 Participants
Race (NIH/OMB) White	91 Participants n=93 Participants	43 Participants n=4 Participants	134 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=93 Participants	0 Participants n=4 Participants	4 Participants n=27 Participants
Region of Enrollment United States	106 participants n=93 Participants	48 participants n=4 Participants	154 participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline to up to 14 days after the last dose

Population: Participants with tumor present in tissue sections from both the pre and post-intervention biopsies

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.

Outcome measures

Outcome measures
Measure	Arm I (Rilimogene-galvacirepvec) n=72 Participants 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	Arm II (Placebo) n=28 Participants 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
Change in CD8+ Positive Cells in the Stroma Adjacent to Tumor and Within the Malignant Portion of the Prostate Biopsies	12.2 number of positive cells per mm^2 Standard Deviation 151.4	-6.9 number of positive cells per mm^2 Standard Deviation 154

PRIMARY outcome

Timeframe: Baseline to up to 14 days after the last dose

Population: Participants with tumor present on the tissue sections from both the pre and post-intervention biopsies were included in the analysis

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.

Outcome measures

Outcome measures
Measure	Arm I (Rilimogene-galvacirepvec) n=69 Participants 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	Arm II (Placebo) n=28 Participants 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
Change in CD4+ Positive Cells in the Stroma Adjacent to Tumor and Within the Malignant Portion of the Prostate Biopsies	4.6 number of positive cells per mm^2 Standard Deviation 166.7	5.8 number of positive cells per mm^2 Standard Deviation 261.1

SECONDARY outcome

Timeframe: Baseline to 6 months post-intervention

Population: Data were not obtained.

Change (from pre to post-intervention) in PD-L1 positive cells in the stroma adjacent to tumor and within the malignant portion of the prostate biopsies

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 6 months post-intervention

Population: The initial protocol did not include participant follow-up at 6 months post-intervention. Participants with available PSA data at baseline and at 6 months post-intervention were included in the analysis.

Change (from baseline to 6 months post-intervention) in prostate-specific antigen (PSA)

Outcome measures

Outcome measures
Measure	Arm I (Rilimogene-galvacirepvec) n=76 Participants 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	Arm II (Placebo) n=35 Participants 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
Change in Prostate-specific Antigen (PSA)	0.26 ng/ml Standard Deviation 2.36	-0.66 ng/ml Standard Deviation 3.49

SECONDARY outcome

Timeframe: Baseline to up to 14 days after the last dose

Population: Participants with benign tissue present in tissue sections from both the pre and post-intervention biopsies were included in the analysis.

Change (from pre to post-intervention) in CD8+ positive cells in the benign portion of the prostate biopsies

Outcome measures

Outcome measures
Measure	Arm I (Rilimogene-galvacirepvec) n=74 Participants 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	Arm II (Placebo) n=34 Participants 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
Change in CD8+ Positive Cells in the Benign Portion of the Prostate Biopsies	7.22 number of positive cells per mm^2 Standard Deviation 202.94	45.25 number of positive cells per mm^2 Standard Deviation 198.25

SECONDARY outcome

Timeframe: Baseline to up to 14 days after the last dose

Population: Participants with benign tissue present in tissue sections from both the pre and post-intervention biopsies were included in the analysis.

Change (from pre to post-intervention) in CD4+ positive cells in the benign portion of the prostate biopsies

Outcome measures

Outcome measures
Measure	Arm I (Rilimogene-galvacirepvec) n=69 Participants 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	Arm II (Placebo) n=34 Participants 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
Change in CD4+ Positive Cells in the Benign Portion of the Prostate Biopsies	73.41 number of positive cells per mm^2 Standard Deviation 287.74	-19.75 number of positive cells per mm^2 Standard Deviation 206.59

SECONDARY outcome

Timeframe: Baseline to up to 14 days after the last dose

Population: Data were not obtained.

Change (from pre to post-intervention) in PD-L1 positive cells in the benign portion of the prostate biopsies

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to up to 14 days after the last dose

Population: The number of participants analyzed is different from the numbers provided in the Participant Flow Module because 2 participants in the placebo arm did not undergo the post-intervention biopsy to provide the data for the analysis.

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.

Outcome measures

Outcome measures
Measure	Arm I (Rilimogene-galvacirepvec) n=106 Participants 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	Arm II (Placebo) n=46 Participants 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
Tumor Grade Progression	8 Participants	6 Participants

SECONDARY outcome

Timeframe: Baseline to up to 14 days after the last dose

Population: The number of participants analyzed is different from the numbers provided in the Participant Flow Module because 2 participants in the placebo arm did not undergo the post-intervention biopsy to provide the data for the analysis.

Assessed by change (from pre to post-intervention) in percent positive random cores

Outcome measures

Outcome measures
Measure	Arm I (Rilimogene-galvacirepvec) n=106 Participants 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	Arm II (Placebo) n=46 Participants 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
Change in Tumor Extent	-1.7 percentage of total cores Standard Deviation 16.1	1.6 percentage of total cores Standard Deviation 15.2

SECONDARY outcome

Timeframe: Up to 14 days after the last dose

Population: The number of participants analyzed is different from the numbers provided in the Participant Flow Module because 2 participants in the placebo arm did not undergo the post-intervention biopsy to provide the data for the analysis.

Assessed by the proportion of patients with no cancer on the post-intervention biopsy

Outcome measures

Outcome measures
Measure	Arm I (Rilimogene-galvacirepvec) n=106 Participants 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	Arm II (Placebo) n=46 Participants 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
Proportion of Men With no Cancer in the Post-intervention Biopsy	25 Participants	8 Participants

SECONDARY outcome

Timeframe: Up to 14 days after the last dose

Population: Data were not collected.

The size of dominant MRI lesion.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to up to 14 days after the last dose

Population: Data were not collected.

Change (from pre to post-intervention) in circulating 15-Mer PSA-specific T cells

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to up to 14 days after the last dose

Population: Data were not collected.

Change (from pre to post-intervention) in soluble antibodies to tumor-associated antigens

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 14 days after the last dose

Population: Data were not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to up to 6 months post-intervention

Population: The initial protocol did not include participant follow-up at 6 months post-intervention. Participants with available IPSS data at baseline and at 6 months post-intervention were included in the analysis.

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.

Outcome measures

Outcome measures
Measure	Arm I (Rilimogene-galvacirepvec) n=58 Participants 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	Arm II (Placebo) n=30 Participants 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
Change in International Prostate Symptom Score	-0.12 score on a scale Standard Deviation 4.67	0.87 score on a scale Standard Deviation 3.57

Adverse Events

Arm I (Rilimogene-galvacirepvec)

Serious events: 1 serious events

Other events: 103 other events

Deaths: 1 deaths

Arm II (Placebo)

Serious events: 0 serious events

Other events: 48 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm I (Rilimogene-galvacirepvec) n=106 participants at risk 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	Arm II (Placebo) n=48 participants at risk 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
Injury, poisoning and procedural complications Fall	0.94% 1/106 • 30 days after the last study dose was given	0.00% 0/48 • 30 days after the last study dose was given

Other adverse events

Additional Information

Sherry Chow, PhD

University of Arizona

Phone: 520-626-3358

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Arm I (Rilimogene-galvacirepvec) n=106 participants at risk 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	Arm II (Placebo) n=48 participants at risk 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
Gastrointestinal disorders Diarrhea	9.4% 10/106 • 30 days after the last study dose was given	12.5% 6/48 • 30 days after the last study dose was given
Gastrointestinal disorders Nausea	8.5% 9/106 • 30 days after the last study dose was given	4.2% 2/48 • 30 days after the last study dose was given
General disorders Fatigue	40.6% 43/106 • 30 days after the last study dose was given	29.2% 14/48 • 30 days after the last study dose was given
General disorders Fever	16.0% 17/106 • 30 days after the last study dose was given	12.5% 6/48 • 30 days after the last study dose was given
Hepatobiliary disorders Flu like syndromes	59.4% 63/106 • 30 days after the last study dose was given	62.5% 30/48 • 30 days after the last study dose was given
General disorders Injection site reaction	89.6% 95/106 • 30 days after the last study dose was given	93.8% 45/48 • 30 days after the last study dose was given
Infections and infestations Upper respiratory infection	9.4% 10/106 • 30 days after the last study dose was given	8.3% 4/48 • 30 days after the last study dose was given
Injury, poisoning and procedural complications Bruising	5.7% 6/106 • 30 days after the last study dose was given	6.2% 3/48 • 30 days after the last study dose was given
Investigations White blood cell decreased	0.94% 1/106 • 30 days after the last study dose was given	8.3% 4/48 • 30 days after the last study dose was given
Musculoskeletal and connective tissue disorders Back pain	6.6% 7/106 • 30 days after the last study dose was given	8.3% 4/48 • 30 days after the last study dose was given
Musculoskeletal and connective tissue disorders Myalgia	7.5% 8/106 • 30 days after the last study dose was given	4.2% 2/48 • 30 days after the last study dose was given
Renal and urinary disorders Renal and urinary disorders - others	1.9% 2/106 • 30 days after the last study dose was given	8.3% 4/48 • 30 days after the last study dose was given
Respiratory, thoracic and mediastinal disorders Sore throat	4.7% 5/106 • 30 days after the last study dose was given	6.2% 3/48 • 30 days after the last study dose was given
Skin and subcutaneous tissue disorders Rash maculo-papular	1.9% 2/106 • 30 days after the last study dose was given	8.3% 4/48 • 30 days after the last study dose was given
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - other	2.8% 3/106 • 30 days after the last study dose was given	8.3% 4/48 • 30 days after the last study dose was given
Nervous system disorders Dizziness	9.4% 10/106 • 30 days after the last study dose was given	0.00% 0/48 • 30 days after the last study dose was given
Nervous system disorders Headache	21.7% 23/106 • 30 days after the last study dose was given	18.8% 9/48 • 30 days after the last study dose was given