Adjuvant PROSTVAC-V/F in Subjects at High Risk for Relapse After Radical Prostatectomy

NCT02772562 | Terminated Phase 2 Results DMC

• 1 other identifier: 102377
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatic Neoplasms

Keywords

prostate cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (3)

• Comparison of Observed vs. Predicted RFS

  2 years

• Observed Relapse Free Survival (RFS) With the RFSs of a Historical Comparison Group of MUSC Prostatectomy Patients.

  2 years

• Associations Between RFS Values and Research Specimen

  2 years

Study Arms (1)

PROSTVAC-V/F

EXPERIMENTAL

Biological: PROSTVAC-V/F

Interventions

PROSTVAC-V/F BIOLOGICAL

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.

PROSTVAC-V/F

Eligibility Criteria

• Age: 21 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Bavarian Nordic: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. Michael Lilly
• Organization: Medical University of South Carolina

lillym@musc.edu

843-792-4271

Study Officials

• Michael Lilly, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2016
• First Posted: May 13, 2016
• Study Start: July 18, 2016
• Primary Completion: April 29, 2024
• Study Completion: April 29, 2024
• Last Updated: December 12, 2025
• Results First Posted: December 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)