Trial Outcomes & Findings for Adjuvant PROSTVAC-V/F in Subjects at High Risk for Relapse After Radical Prostatectomy (NCT NCT02772562)
NCT ID: NCT02772562
Last Updated: 2025-12-12
Results Overview
RFS is defined as the absence of relapse (PSA ≥ 0.2 ng/mL confirmed \>30 days later, radiographic metastasis, initiation of new prostate cancer therapy, or death) at 2 years after prostatectomy. The measure represents the proportion of participants who remain relapse-free at 24 months post-surgery.
TERMINATED
PHASE2
33 participants
2 years
2025-12-12
Participant Flow
Participant milestones
| Measure |
PROSTVAC-V/F
PROSTVAC-V/F: 0.5 ml containing at least 2 x 108 Infectious Units (Inf.U) PROSTVAC-V given on day 1.
0.5 ml containing at least 1 x 109 Inf.U PROSTVAC-F given on days 15, 28, 57, 85, 113, 141.
|
|---|---|
|
Overall Study
STARTED
|
33
|
|
Overall Study
COMPLETED
|
31
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
PROSTVAC-V/F
PROSTVAC-V/F: 0.5 ml containing at least 2 x 108 Infectious Units (Inf.U) PROSTVAC-V given on day 1.
0.5 ml containing at least 1 x 109 Inf.U PROSTVAC-F given on days 15, 28, 57, 85, 113, 141.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Protocol Violation
|
1
|
Baseline Characteristics
Adjuvant PROSTVAC-V/F in Subjects at High Risk for Relapse After Radical Prostatectomy
Baseline characteristics by cohort
| Measure |
PROSTVAC-V/F
n=33 Participants
PROSTVAC-V/F: 0.5 ml containing at least 2 x 108 Infectious Units (Inf.U) PROSTVAC-V given on day 1.
0.5 ml containing at least 1 x 109 Inf.U PROSTVAC-F given on days 15, 28, 57, 85, 113, 141.
|
|---|---|
|
Age, Continuous
|
63.0 years
n=9 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: 2 yearsRFS is defined as the absence of relapse (PSA ≥ 0.2 ng/mL confirmed \>30 days later, radiographic metastasis, initiation of new prostate cancer therapy, or death) at 2 years after prostatectomy. The measure represents the proportion of participants who remain relapse-free at 24 months post-surgery.
Outcome measures
| Measure |
PROSTVAC-V/F
n=31 Participants
PROSTVAC-V/F: 0.5 ml containing at least 2 x 108 Infectious Units (Inf.U) PROSTVAC-V given on day 1.
0.5 ml containing at least 1 x 109 Inf.U PROSTVAC-F given on days 15, 28, 57, 85, 113, 141.
|
|---|---|
|
Relapse-Free Survival (RFS) at 2 Years Post-Prostatectomy
|
0.352 Proportion of participants
95% Confidence Interval .97 • Interval 0.154 to 0.55
|
SECONDARY outcome
Timeframe: 2 yearsA secondary endpoint will be a comparison of the observed RFSs with the predicted ("virtual") RFS for the same patients based on clinical and pathologic information collected at baseline. The observed RFSs of the treated subjects are compared with the predicted RFSs as if the same subjects had not been treated. The comparison is performed using the logrank test of the observed and predicted RFSs. These represent the estimated RFSs for patients with those clinical characteristics if they did not receive any adjuvant therapy.
Outcome measures
| Measure |
PROSTVAC-V/F
n=31 Participants
PROSTVAC-V/F: 0.5 ml containing at least 2 x 108 Infectious Units (Inf.U) PROSTVAC-V given on day 1.
0.5 ml containing at least 1 x 109 Inf.U PROSTVAC-F given on days 15, 28, 57, 85, 113, 141.
|
|---|---|
|
Comparison of Observed vs. Predicted RFS
|
.352 proportion of participants
Interval 0.154 to 0.55
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: No participants were analyzed for this outcome. Although the outcome was pre-specified in the protocol, the study was terminated early and the planned analysis comparing observed relapse-free survival (RFS) to a historical control group could not be completed. Additionally, the analysis population for this outcome was not clearly defined at the time of study closure, and no summary data were generated.
No participants were analyzed for this outcome. Although the outcome was pre-specified in the protocol, the study was terminated early and the planned analysis comparing observed relapse-free survival (RFS) to a historical control group could not be completed. Additionally, the analysis population for this outcome was not clearly defined at the time of study closure, and no summary data were generated.
Outcome measures
| Measure |
PROSTVAC-V/F
PROSTVAC-V/F: 0.5 ml containing at least 2 x 108 Infectious Units (Inf.U) PROSTVAC-V given on day 1.
0.5 ml containing at least 1 x 109 Inf.U PROSTVAC-F given on days 15, 28, 57, 85, 113, 141.
|
|---|---|
|
Observed Relapse Free Survival (RFS) With the RFSs of a Historical Comparison Group of MUSC Prostatectomy Patients.
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: While most participants were assessed at the scheduled time points, no usable samples due to issues such as hemolysis, insufficient volume, or improper storage conditions rendered them unusable for the planned immunologic assays. No data are available for this outcome measure due to these technical limitations.
While most participants were assessed at the scheduled time points, no usable samples due to issues such as hemolysis, insufficient volume, or improper storage conditions rendered them unusable for the planned immunologic assays. No data are available for this outcome measure due to these technical limitations.
Outcome measures
| Measure |
PROSTVAC-V/F
PROSTVAC-V/F: 0.5 ml containing at least 2 x 108 Infectious Units (Inf.U) PROSTVAC-V given on day 1.
0.5 ml containing at least 1 x 109 Inf.U PROSTVAC-F given on days 15, 28, 57, 85, 113, 141.
|
|---|---|
|
Associations Between RFS Values and Research Specimen
|
0 Participants
|
Adverse Events
PROSTVAC-V/F
Serious adverse events
| Measure |
PROSTVAC-V/F
n=32 participants at risk
PROSTVAC-V/F: 0.5 ml containing at least 2 x 108 Infectious Units (Inf.U) PROSTVAC-V given on day 1.
0.5 ml containing at least 1 x 109 Inf.U PROSTVAC-F given on days 15, 28, 57, 85, 113, 141.
|
|---|---|
|
Cardiac disorders
Myocardial Infarction
|
3.1%
1/32 • up to 2 years
|
Other adverse events
| Measure |
PROSTVAC-V/F
n=32 participants at risk
PROSTVAC-V/F: 0.5 ml containing at least 2 x 108 Infectious Units (Inf.U) PROSTVAC-V given on day 1.
0.5 ml containing at least 1 x 109 Inf.U PROSTVAC-F given on days 15, 28, 57, 85, 113, 141.
|
|---|---|
|
Infections and infestations
Other Sinusitis
|
3.1%
1/32 • up to 2 years
|
|
Infections and infestations
Other Stye
|
3.1%
1/32 • up to 2 years
|
|
Infections and infestations
Other Uri
|
3.1%
1/32 • up to 2 years
|
|
Injury
Other Rib Fracture
|
3.1%
1/32 • up to 2 years
|
|
Investigations
Other Weight Loss
|
3.1%
1/32 • up to 2 years
|
|
Metabolism
Other Hypocarbia
|
3.1%
1/32 • up to 2 years
|
|
Metabolism
Other Hypophosphatemia
|
3.1%
1/32 • up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Other Aches
|
3.1%
1/32 • up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Other Back Pain
|
3.1%
1/32 • up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Other Breast Soreness
|
3.1%
1/32 • up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Other Costochondritis
|
3.1%
1/32 • up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Other Inguinal Hernia
|
3.1%
1/32 • up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Other Joint Pain
|
3.1%
1/32 • up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Other Leg Cramping In Left Leg
|
3.1%
1/32 • up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Other Neck Pain
|
3.1%
1/32 • up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Other Stiffness
|
3.1%
1/32 • up to 2 years
|
|
Nervous system disorders
Dizziness
|
3.1%
1/32 • up to 2 years
|
|
Nervous system disorders
Headache
|
3.1%
1/32 • up to 2 years
|
|
Psychiatric disorders
Other Agitation
|
3.1%
1/32 • up to 2 years
|
|
Renal and urinary disorders
Other Bladder Spasms
|
3.1%
1/32 • up to 2 years
|
|
Renal and urinary disorders
Other Dysuria
|
3.1%
1/32 • up to 2 years
|
|
Reproductive
Other Testicular Pain (Left)
|
3.1%
1/32 • up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Other Cough
|
3.1%
1/32 • up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Other Dyspnea
|
3.1%
1/32 • up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Other Nasal Congestion
|
3.1%
1/32 • up to 2 years
|
|
Skin
Other Left Chest Dermatomal Erythematous Papules And Erosions
|
3.1%
1/32 • up to 2 years
|
|
Skin
Other Lesion L Middle Finger
|
3.1%
1/32 • up to 2 years
|
|
Skin
Other Lesion L Knee
|
3.1%
1/32 • up to 2 years
|
|
Skin
Other Lesion Lower Lip
|
3.1%
1/32 • up to 2 years
|
|
Skin
Other New Bump On Left Arm
|
3.1%
1/32 • up to 2 years
|
|
Skin
Other Rash
|
3.1%
1/32 • up to 2 years
|
|
Surgical and medical procedures
Other Dental Caries (Abscessed Tooth Extraction)
|
3.1%
1/32 • up to 2 years
|
|
Surgical and medical procedures
Other Incisional Hernia
|
3.1%
1/32 • up to 2 years
|
|
General
Injection site reaction
|
40.6%
13/32 • up to 2 years
|
|
General
Fatigue
|
18.8%
6/32 • up to 2 years
|
|
General
Flu like symptoms
|
18.8%
6/32 • up to 2 years
|
|
General
Fever
|
12.5%
4/32 • up to 2 years
|
|
General
Injection site pain
|
12.5%
4/32 • up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
4/32 • up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
9.4%
3/32 • up to 2 years
|
|
Gastrointestinal disorders
Other Vomiting
|
9.4%
3/32 • up to 2 years
|
|
Blood
Increased Alt
|
6.2%
2/32 • up to 2 years
|
|
Blood
Increased Ast
|
6.2%
2/32 • up to 2 years
|
|
General
Chills
|
6.2%
2/32 • up to 2 years
|
|
General
Edema limbs
|
6.2%
2/32 • up to 2 years
|
|
General
Other Malaise
|
6.2%
2/32 • up to 2 years
|
|
Psychiatric disorders
Other Depression
|
6.2%
2/32 • up to 2 years
|
|
Renal and urinary disorders
Other Urinary Frequency
|
6.2%
2/32 • up to 2 years
|
|
Skin
Other Pruritus
|
6.2%
2/32 • up to 2 years
|
|
Blood
Other Alkaline Phosphotase Increased
|
3.1%
1/32 • up to 2 years
|
|
Blood
Other Hemoglobinopathy
|
3.1%
1/32 • up to 2 years
|
|
Cardiac disorders
Other Hypertension
|
3.1%
1/32 • up to 2 years
|
|
Ear
Other Pounding Sensation; Right Ear
|
3.1%
1/32 • up to 2 years
|
|
Gastrointestinal disorders
Other Constipation
|
3.1%
1/32 • up to 2 years
|
|
Gastrointestinal disorders
Other Dyspepsia
|
3.1%
1/32 • up to 2 years
|
|
Gastrointestinal disorders
Other Gastric Hemorrhage
|
3.1%
1/32 • up to 2 years
|
|
General
Other Hypokalemia
|
3.1%
1/32 • up to 2 years
|
|
Immune
Other Anemia
|
3.1%
1/32 • up to 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place