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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
Must not have
Active infections requiring systemic therapy
History of myocardial disease, such as myocarditis, cardiomyopathy, congestive heart failure, ischemic cardiomyopathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Summary
This trial is testing PROSTVAC-V/F, an experimental drug, to see if it can prevent prostate cancer from returning in men who have had prostate surgery and are at high risk of relapse. The drug works by boosting the immune system to fight any leftover cancer cells. PROSTVAC has shown promise in improving overall survival in advanced prostate cancer.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently on medication for an active infection.
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I have a history of heart muscle disease.
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I have had a solid organ or stem cell transplant in the past.
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I am not currently taking any drugs that suppress my immune system.
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I have a skin condition like eczema or psoriasis affecting my skin's surface.
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My prostate cancer is classified as pure small cell carcinoma.
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I was diagnosed with cancer needing treatment through the bloodstream in the last 5 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Anti-tumor effect of PROSTVAC-V/F
Secondary study objectives
Observed relapse free survival (RFS) with the predicted "virtual" RFS of each patient.
Side effects data
From 2023 Phase 1 & 2 trial • 24 Patients • NCT02933255100%
Injection site reaction
58%
Fatigue
50%
Hyperglycemia
42%
Alanine aminotransferase increased
42%
Aspartate aminotransferase increased
33%
Headache
33%
Cough
33%
Rash acneiform
33%
Myalgia
33%
Anemia
33%
Fall
33%
Hypophosphatemia
25%
Fever
25%
Hypoalbuminemia
25%
Creatinine increased
25%
Lipase increased
25%
Pain
25%
Urinary incontinence
25%
Urinary retention
25%
Abdominal pain
25%
Dizziness
25%
Constipation
25%
Urinary tract infection
25%
Upper respiratory infection
17%
Anorexia
17%
Insomnia
17%
Blurred vision
17%
Edema limbs
17%
Diarrhea
17%
Lymphocyte count decreased
17%
Proteinuria
17%
Rash maculo-papular
17%
Gait disturbance
17%
Alkaline phosphatase increased
17%
Hyperkalemia
17%
Nasal congestion
17%
Nausea
17%
Serum amylase increased
17%
Muscle weakness lower limb
17%
Urinary frequency
8%
Dyspnea
8%
Blood bilirubin increased
8%
Pain in extremity
8%
Adrenal insufficiency
8%
Flu like symptoms
8%
Sinus bradycardia
8%
Duodenal obstruction
8%
Gastrointestinal disorders - Other, Polydipsia
8%
Glaucoma
8%
Hypertension
8%
Myositis
8%
Chest pain - cardiac
8%
Eye disorders - Other, Blepharitis
8%
Gynecomastia
8%
Surgical and medical procedures - Other, left percutaneous nephrostomy
8%
Back pain
8%
Lung infection
8%
Flank pain
8%
Vomiting
8%
Myocarditis
8%
General disorders and administration site conditions - Other, sweating intermittent
8%
Hematuria
8%
Mucositis oral
8%
Photophobia
8%
Skin and subcutaneous tissue disorders - Other, Right groin incision disorder
8%
Colitis
8%
Bruising
8%
Platelet count decreased
8%
Sinus tachycardia
8%
Hypotension
8%
Hypoxia
8%
Weight loss
8%
GGT increased
8%
Nystagmus
8%
Infections and infestations - Other, Herpes simplex reactivation
8%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
8%
Skin and subcutaneous tissue disorders - Other, specify
8%
Skin and subcutaneous tissue disorders - Other, skin rash eyes area and hands
8%
Surgical and medical procedures - Other, Ultrasound guided percutaneous drain for findings of left
8%
Surgical and medical procedures - Other, rt nephro-ureterostomy tube exchange
8%
Tooth infection
8%
Urinary tract obstruction
8%
Hypothyroidism
8%
Pruritus
8%
Kidney infection
8%
Hyperthyroidism
8%
Renal and urinary disorders - Other, UTI
8%
Surgical and medical procedures - Other, Positive Cologuard test
8%
Memory impairment
8%
Skin infection
8%
Confusion
8%
Vestibular disorder
8%
CPK increased
8%
Hypermagnesemia
8%
Hypernatremia
8%
Cystitis noninfective
8%
Generalized muscle weakness
8%
Dry eye
8%
Dry skin
8%
Non-cardiac chest pain
8%
Renal and urinary disorders - Other, Pyelonephritis
8%
Blood and lymphatic system disorders - Other, Amylase increased
8%
Blood and lymphatic system disorders - Other, Thrombocytopenia
8%
Gastrointestinal disorders - Other, degenerative teeth 22&27
8%
Infections and infestations - Other, Viral Infection
8%
Respiratory, thoracic and mediastinal disorders - Other, shortness of breath
8%
Surgical and medical procedures - Other, BL ureteral stent exchanges- Annual
8%
Surgical and medical procedures - Other, Bilateral stent placements
8%
Injury, poisoning and procedural complications - Other, Abrasions left hand
8%
Injury, poisoning and procedural complications - Other, Mild head injury (hit his head)
8%
Metabolism and nutrition disorders - Other, Poor appetite
8%
Nervous system disorders - Other, lightness - positional standing up
8%
Respiratory, thoracic and mediastinal disorders - Other, Cold symptoms
8%
Jejunal obstruction
8%
General disorders and administration site conditions - Other, retching, gagging
8%
Hypoglycemia
8%
Hypomagnesemia
8%
Cataract
8%
Dehydration
8%
Surgical and medical procedures - Other, Esophagogastroduodenoscopy
8%
Surgical and medical procedures - Other, Small bowel resection
8%
Uveitis
8%
Conjunctivitis
8%
Breast pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lead-in Metastatic Castration-Resistant Prostate Cancer (mCRPC) Cohort
Neoadjuvant Cohort
Trial Design
1Treatment groups
Experimental Treatment
Group I: PROSTVAC-V/FExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PROSTVAC-V/F
2016
Completed Phase 2
~60
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Prostate cancer treatments often include immunotherapy approaches such as therapeutic cancer vaccines, which aim to stimulate the patient's immune system to recognize and destroy cancer cells. PROSTVAC-V/F, for example, is designed to target prostate-specific antigens and enhance the body's immune response against prostate cancer cells, potentially preventing relapse after surgery.
Other common treatments include androgen deprivation therapy (ADT), which reduces levels of male hormones that can fuel cancer growth, and checkpoint inhibitors like pembrolizumab, which block proteins that prevent the immune system from attacking cancer cells. These treatments are crucial as they offer targeted approaches to manage and potentially eradicate prostate cancer, improving survival rates and quality of life for patients.
Clinical trials of cancer therapies targeting prostate-specific membrane antigen.
Clinical trials of cancer therapies targeting prostate-specific membrane antigen.
Find a Location
Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
963 Previous Clinical Trials
7,399,456 Total Patients Enrolled
19 Trials studying Prostate Cancer
781 Patients Enrolled for Prostate Cancer
Bavarian NordicIndustry Sponsor
62 Previous Clinical Trials
50,355 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
183 Total Patients Enrolled
5 Trials studying Prostate Cancer
128 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.
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