- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02772562
Adjuvant PROSTVAC-V/F in Subjects at High Risk for Relapse After Radical Prostatectomy
January 29, 2024 updated by: Medical University of South Carolina
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
33
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
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
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anti-tumor effect of PROSTVAC-V/F
Time Frame: 2 years
|
Anti-tumor effect of PROSTVAC-V/F will be determined by the number of subjects experiencing relapse at the two year follow up visit after prostatectomy.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Observed relapse free survival (RFS) with the predicted "virtual" RFS of each patient.
Time Frame: 2 years
|
The predicted RFS values will be calculated from each patient's clinicl and pathologic data by a risk adapted algorithm.
The observed and predicted RFSs will be presented as Kaplan-Meier plots and comparisons will be done by the longrank test.
|
2 years
|
Observed relapse free survival (RFS) with the RFSs of a historical comparison group of MUSC prostatectomy patients.
Time Frame: 2 years
|
2 years
|
|
Associations between RFS values and research specimen
Time Frame: 2 years
|
2 years
|
|
Frequency of adverse events as assessed by CTCAE v. 4
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Michael Lilly, MD, Medical University of South Carolina
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 18, 2016
Primary Completion (Estimated)
March 31, 2024
Study Completion (Estimated)
June 30, 2024
Study Registration Dates
First Submitted
May 3, 2016
First Submitted That Met QC Criteria
May 11, 2016
First Posted (Estimated)
May 13, 2016
Study Record Updates
Last Update Posted (Actual)
January 31, 2024
Last Update Submitted That Met QC Criteria
January 29, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 102377
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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