A Phase II Trial of Adjuvant PROSTVAC-V/F in Subjects at High Risk for Relapse After Radical Prostatectomy

Medical University of South Carolina1 site in 1 country33 target enrollmentJuly 18, 2016

ConditionsProstatic Neoplasms

InterventionsPROSTVAC-V/F

DrugsPROSTVAC-V/F

Overview

Phase: Phase 2
Intervention: PROSTVAC-V/F
Conditions: Prostatic Neoplasms
Sponsor: Medical University of South Carolina
Enrollment: 33
Locations: 1
Primary Endpoint: Relapse-Free Survival (RFS) at 2 Years Post-Prostatectomy
Status: Terminated
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 18, 2016

End Date

April 29, 2024

Last Updated

4 months ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Medical University of South Carolina

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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

Arms & Interventions

PROSTVAC-V/F

Intervention: PROSTVAC-V/F

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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)