Prostatic Neoplasms
Conditions
Keywords
prostate cancer
Brief summary
The purpose of this study is to see how well PROSTVAC -V/F works in stopping prostate cancer from coming back or relapsing. This study will also look at the safety of PROSTVAC-V/F.
Detailed description
This study is for adult male patients who have recently undergone radical prostatectomy and are at high risk for relapse. The purpose of this study is to look at the effect PROSTVAC-V/F has in preventing or prolonging relapse after surgery. PROSTVAC-V/F is an investigational drug.
Interventions
BIOLOGICALPROSTVAC-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.
Sponsors
Bavarian Nordic
Medical University of South Carolina
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \>21 2. Completed radical prostatectomy for pathologically-verified adenocarcinoma of the prostate no more than 120 days prior to start of treatment. The following procedures are acceptable: radical retropubic prostatectomy (RRP), laparoscopic radical prostatectomy (with or without robotic assistance; LAPD), radical perineal prostatectomy (RPP). 3. Post-operative PSA \<0.2ng/mL by 120 days after prostatectomy 4. Must have one or more of the following: * pT3b or pT4 primary tumor * Gleason score 8-10 * pN1 lymph node disease * positive surgical margins * pre-operative PSA of \> 10ng/mL * presence of any tertiary Gleason 5 component on the prostatectomy pathology report. Note: Patients with pT3a disease who lack one of the above criteria, and who refuse adjuvant radiation, may also be enrolled. 5. ECOG performance status 0-1 6. Adequate hematologic, renal, liver function per parameters in Table 1 7. Subject of fathering potential must agree to use an adequate method of contraception to avoid conception throughout the study and for at least 4 weeks after the last dose of study drug to minimize the risk of pregnancy. 8. Subjects must have had a negative bone scan, and CT of abdomen and pelvis within 16 weeks prior to registration. Additional forms of imaging (Prostascint scan, MRI) may be substituted for a CT scan of the abdomen and pelvis if clinically indicated.
Exclusion criteria
1. Pure small cell carcinoma of the prostate 2. Radiographically-demonstrable metastases at any time prior to the time of enrollment 3. Diagnosis of cancer requiring systemic therapy in the past 5 years 4. Presence of any major medical condition which, in the opinion of the investigator, precludes participation in the study 5. Neoadjuvant or adjuvant therapy of any kind 6. Chronic administration (defined as daily or every other day for continued use \> 14 days) of systemic glucocorticoids within 28 days of the first planned dose of PROSTVAC-V/F. Use of inhaled steroids, nasal sprays, and all topical preparations (creams, solutions, gels, ointments, etc.) for up to 5% of the body surface area is allowed. 7. Use of systemic immunosuppressant agents including anti-metabolites, glucocorticoids, TNF antagonists, antibodies to IL6 or IL6R, calcineurin inhibitors, mTOR antagonists 8. Prior history of serious toxicity or a systemic reaction to vaccinia immunization such as myopericarditis progressive vaccinia infection, or eczema vaccinatum. 9. Inflammatory or exfoliative skin diseases such as eczema, psoriasis that disrupt epidermis 10. Active infections requiring systemic therapy 11. Serologic evidence of HIV/AIDS. 12. Positive hepatitis C serology or active hepatitis B infection. 13. History of allergy to eggs, egg products, aminoglycoside antibiotics 14. History of myocardial disease, such as myocarditis, cardiomyopathy, congestive heart failure, ischemic cardiomyopathy 15. Prior solid organ or stem cell transplant 16. History of or active autoimmune disease (e.g., autoimmune neutropenia, thrombocytopenia, or hemolytic anemia, systemic lupus, localized lupus, Sjogren's syndrome, scleroderma, myasthenia gravis, Goodpasture's syndrome, or Addison's disease). Persons with vitiligo, Hashimoto's thyroiditis, or Graves disease are not excluded. 17. Vaccination with live attenuated vaccine within 28 days prior to day 1 of PROSTVAC-V/F administration or vaccination with a killed vaccine within 14 days prior to day 1 of PROSTVAC-V/F. 18. Inability to avoid close contact or household contact with the following high-risk individuals for three weeks after the Day 1 vaccination or until the vaccination site heals completely: (a) children ≤ 3 years of age; (b) pregnant or nursing women; (c) individuals with prior or concurrent extensive eczema or other eczemoid skin disorders; or (d) immunocompromised individuals, such as those with HIV. 19. Any condition which, in the opinion of the investigator, would prevent full participation in this trial (including Follow-Up), or would interfere with the evaluation of the trial endpoints.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relapse-Free Survival (RFS) at 2 Years Post-Prostatectomy | 2 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Observed vs. Predicted RFS | 2 years | A 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. |
| Observed Relapse Free Survival (RFS) With the RFSs of a Historical Comparison Group of MUSC Prostatectomy Patients. | 2 years | 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. |
| Associations Between RFS Values and Research Specimen | 2 years | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 33 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | PROSTVAC-V/F |
|---|---|
| Age, Continuous | 63.0 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 24 Participants |
| Region of Enrollment United States | 33 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 32 |
| other Total, other adverse events | 28 / 32 |
| serious Total, serious adverse events | 1 / 32 |
Outcome results
Primary
Relapse-Free Survival (RFS) at 2 Years Post-Prostatectomy
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.
Time frame: 2 years
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| PROSTVAC-V/F | Relapse-Free Survival (RFS) at 2 Years Post-Prostatectomy | 0.352 Proportion of participants | 95% Confidence Interval 0.97 |
Secondary
Associations Between RFS Values and Research Specimen
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.
Time frame: 2 years
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PROSTVAC-V/F | Associations Between RFS Values and Research Specimen | 0 Participants |
Secondary
Comparison of Observed vs. Predicted RFS
A 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.
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROSTVAC-V/F | Comparison of Observed vs. Predicted RFS | .352 proportion of participants |
Secondary
Observed Relapse Free Survival (RFS) With the RFSs of a Historical Comparison Group of MUSC Prostatectomy Patients.
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.
Time frame: 2 years
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PROSTVAC-V/F | Observed Relapse Free Survival (RFS) With the RFSs of a Historical Comparison Group of MUSC Prostatectomy Patients. | 0 Participants |