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PROSTVAC-V/F for Prostate Cancer
Phase 2
Waitlist Available
Led By Michael Lilly, MD
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >21
Post-operative PSA <0.2ng/mL by 120 days after prostatectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will study how effective PROSTVAC-V/F is in preventing prostate cancer from recurring, as well as its safety.
Who is the study for?
Men over 21 who've had prostate cancer surgery with a post-op PSA <0.2ng/mL, good health status, and no signs of metastases on scans. They must have high-risk factors like aggressive tumor features or positive surgical margins. No recent other cancers, major medical conditions, systemic steroids use, immunosuppressants, live vaccines taken recently or close contact with vulnerable individuals.Check my eligibility
What is being tested?
The trial is testing PROSTVAC-V/F to prevent prostate cancer relapse after surgery. It's assessing the vaccine's effectiveness in stopping cancer return and monitoring its safety profile in patients at high risk for relapse.See study design
What are the potential side effects?
While not explicitly listed here, similar cancer vaccines can cause injection site reactions, flu-like symptoms (fever, fatigue), allergic reactions to components like egg products or antibiotics used in the vaccine formulation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 21 years.
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My PSA level was below 0.2ng/mL within 4 months after my prostate surgery.
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My prostate cancer is advanced or aggressive based on specific test results.
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I am fully active or can carry out light work.
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My blood, kidney, and liver tests are within normal ranges.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Anti-tumor effect of PROSTVAC-V/F
Secondary outcome measures
Associations between RFS values and research specimen
Frequency of adverse events as assessed by CTCAE v. 4
Observed relapse free survival (RFS) with the RFSs of a historical comparison group of MUSC prostatectomy patients.
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: PROSTVAC-V/FExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
932 Previous Clinical Trials
7,394,227 Total Patients Enrolled
19 Trials studying Prostate Cancer
779 Patients Enrolled for Prostate Cancer
Bavarian NordicIndustry Sponsor
61 Previous Clinical Trials
49,895 Total Patients Enrolled
1 Trials studying Prostate Cancer
120 Patients Enrolled for Prostate Cancer
Michael Lilly, MDPrincipal InvestigatorMedical University of South Carolina
9 Previous Clinical Trials
181 Total Patients Enrolled
5 Trials studying Prostate Cancer
126 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently on medication for an active infection.I have a history of heart muscle disease.I have had a solid organ or stem cell transplant in the past.I am older than 21 years.My PSA level was below 0.2ng/mL within 4 months after my prostate surgery.I am not currently taking any drugs that suppress my immune system.I have a skin condition like eczema or psoriasis affecting my skin's surface.I have an autoimmune disease, but not vitiligo, Hashimoto's, or Graves' disease.My prostate cancer is classified as pure small cell carcinoma.My prostate cancer is advanced or aggressive based on specific test results.I am fully active or can carry out light work.My blood, kidney, and liver tests are within normal ranges.I had surgery to remove prostate cancer less than 4 months ago.My recent scans showed no signs of cancer in my bones or abdomen.I have not had a live vaccine in the last 28 days or a killed vaccine in the last 14 days.I can avoid close contact with high-risk individuals for 3 weeks after my first vaccine dose or until the vaccination site heals.I have received treatment before or after surgery.I haven't taken systemic steroids in the last 28 days, but I may use inhaled or topical steroids.I was diagnosed with cancer needing treatment through the bloodstream in the last 5 years.
Research Study Groups:
This trial has the following groups:- Group 1: PROSTVAC-V/F
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any positions available in this clinical trial for participants?
"According to clinicaltrials.gov, this particular medical trial is no longer recruiting patients; the original post was made on July 18th 2016 and the last update occurred November 3rd 2022. However, 1252 other trials are currently open for enrollment at present."
Answered by AI
What safety protocols are in place for individuals prescribed PROSTVAC-V/F?
"Based on the available evidence, our team at Power assigned PROSTVAC-V/F a score of 2 due to its Phase 2 status. There is some data that shows safety but none for efficacy yet."
Answered by AI
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