Prostatic NeoplasmsPhase 2NCT02772562
Adjuvant PROSTVAC-V/F in Subjects at High Risk for Relapse After Radical Prostatectomy
A Phase 2 study testing PROSTVAC-V/F in people with Prostatic Neoplasms, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- PROSTVAC-V/F
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2016to 29 Apr 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >21
- 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).
- Post-operative PSA <0.2ng/mL by 120 days after prostatectomy
- Must have one or more of the following:
- pT3b or pT4 primary tumor
- Gleason score 8-10
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- 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.
- ECOG performance status 0-1
- Adequate hematologic, renal, liver function per parameters in Table 1
- 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.
- 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.
Who cannot join
- Pure small cell carcinoma of the prostate
- Radiographically-demonstrable metastases at any time prior to the time of enrollment
- Diagnosis of cancer requiring systemic therapy in the past 5 years
- Presence of any major medical condition which, in the opinion of the investigator, precludes participation in the study
- Neoadjuvant or adjuvant therapy of any kind
- 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.
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- Use of systemic immunosuppressant agents including anti-metabolites, glucocorticoids, TNF antagonists, antibodies to IL6 or IL6R, calcineurin inhibitors, mTOR antagonists
- Prior history of serious toxicity or a systemic reaction to vaccinia immunization such as myopericarditis progressive vaccinia infection, or eczema vaccinatum.
- Inflammatory or exfoliative skin diseases such as eczema, psoriasis that disrupt epidermis
- Active infections requiring systemic therapy
- Serologic evidence of HIV/AIDS.
- Positive hepatitis C serology or active hepatitis B infection.
- History of allergy to eggs, egg products, aminoglycoside antibiotics
- History of myocardial disease, such as myocarditis, cardiomyopathy, congestive heart failure, ischemic cardiomyopathy
- Prior solid organ or stem cell transplant
- 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.
- 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.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: A Phase II Trial of Adjuvant PROSTVAC-V/F in Subjects at High Risk for Relapse After Radical Prostatectomy
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.
Read the 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.
- Conditions
- Prostatic Neoplasms
- Being tested
- PROSTVAC-V/F
- Keywords
- prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROSTVAC-V/FBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| PROSTVAC-V/F | Experimental | Not described Receives: Biological: PROSTVAC-V/F |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (3)
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.
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study start18 Jul 2016
- Primary completion29 Apr 2024
- Study completion29 Apr 2024
Why it stopped: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Bavarian Nordic
- Responsible party
- Sponsor
- Investigators
- Michael Lilly, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02772562
- Sponsor's protocol ID
- 102377
- Status last verified
- Nov 2025
- First submitted
- 3 May 2016
- Last updated
- 12 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Adjuvant PROSTVAC-V/F in Subjects at High Risk for Relapse After Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT02772562
- Acronym / sponsor ID
- 102377
- Conditions
- Prostatic Neoplasms
- Keywords
- prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention.
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Bavarian Nordic
- Study start
- 18 Jul 2016 (actual)
- Primary completion
- 29 Apr 2024 (actual)
- Study completion
- 29 Apr 2024 (actual)
- First posted
- 13 May 2016 (estimated)
- Results
- Posted 12 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PROSTVAC-V/F | Experimental | Biological: PROSTVAC-V/F |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age >21
- 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).
- Post-operative PSA <0.2ng/mL by 120 days after prostatectomy
- Must have one or more of the following:
- Note: Patients with pT3a disease who lack one of the above criteria, and who refuse adjuvant radiation, may also be enrolled.
Key exclusion criteria (19 listed)
- Pure small cell carcinoma of the prostate
- Radiographically-demonstrable metastases at any time prior to the time of enrollment
- Diagnosis of cancer requiring systemic therapy in the past 5 years
- Presence of any major medical condition which, in the opinion of the investigator, precludes participation in the study
- Neoadjuvant or adjuvant therapy of any kind
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PROSTVAC-V/F0.5 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. | Biological | PROSTVAC-V/F |
Primary outcome
Relapse-Free Survival (RFS) at 2 Years Post-Prostatectomy
Time frame: 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.
3 secondary outcomes
Comparison of Observed vs. Predicted RFS
Time frame: 2 years
Observed Relapse Free Survival (RFS) With the RFSs of a Historical Comparison Group of MUSC Prostatectomy Patients.
Time frame: 2 years
Associations Between RFS Values and Research Specimen
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Lilly, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PROSTVAC-V/F in people with Prostatic Neoplasms, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse-Free Survival (RFS) at 2 Years Post-Prostatectomy (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.