What side effects are associated with this type of intervention?

Therapeutic cancer vaccines like PROSTVAC-V/F, which stimulate the immune system to target prostate cancer cells, commonly cause mild side effects such as chills, fatigue, fever, back pain, nausea, joint ache, and headache. Serious adverse events are rare but can include infusion reactions and cerebrovascular events. Other common treatments for prostate cancer, such as androgen deprivation therapy (ADT), can lead to hot flashes, reduced libido, and osteoporosis. Chemotherapy, like docetaxel, often results in fatigue, hair loss, and increased risk of infection. Radiation therapy can cause urinary and bowel issues, as well as erectile dysfunction.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer that stimulate the immune system, similar to the therapeutic cancer vaccine PROSTVAC-V/F. One notable example is Sipuleucel-T (Provenge), an autologous cellular immunotherapy that activates the patient's immune cells to target prostate cancer cells. Additionally, other treatments for prostate cancer include androgen receptor signaling inhibitors like abiraterone and enzalutamide, which are used in various stages of the disease. These treatments, while not vaccines, also play a crucial role in managing prostate cancer by targeting specific pathways involved in cancer progression.

What other types of research exist?

Promising novel alternatives to PROSTVAC-V/F for prostate cancer patients include: 1) Immune checkpoint inhibitors such as anti-PD-1 or anti-PD-L1 therapies, which have shown efficacy in various cancers and are being explored in prostate cancer. 2) Personalized nanovaccines that combine fluoropolymers with cell membranes from resected autologous tumors, potentially enhancing immune response and reducing recurrence. 3) Oncolytic viruses like genetically engineered measles virus, which can selectively infect and kill cancer cells while stimulating an anti-tumor immune response. These alternatives represent cutting-edge approaches in cancer immunotherapy and may offer new hope for prostate cancer patients.

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PROSTVAC-V/F for Prostate Cancer

Q: What is the mechanism of action of this treatment?

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.

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

No Placebo-Only Group

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 below

Select...

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.

Select...

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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

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 • NCT02933255

100%

Injection site reaction

58%

Fatigue

50%

Hyperglycemia

42%

Alanine aminotransferase increased

42%

Aspartate aminotransferase increased

33%

Anemia

33%

Cough

33%

Headache

33%

Myalgia

33%

Rash acneiform

33%

Fall

33%

Hypophosphatemia

25%

Urinary tract infection

25%

Fever

25%

Dizziness

25%

Hypoalbuminemia

25%

Abdominal pain

25%

Lipase increased

25%

Pain

25%

Urinary incontinence

25%

Urinary retention

25%

Constipation

25%

Creatinine increased

25%

Upper respiratory infection

17%

Nasal congestion

17%

Blurred vision

17%

Hyperkalemia

17%

Nausea

17%

Proteinuria

17%

Muscle weakness lower limb

17%

Anorexia

17%

Diarrhea

17%

Gait disturbance

17%

Rash maculo-papular

17%

Edema limbs

17%

Insomnia

17%

Lymphocyte count decreased

17%

Alkaline phosphatase increased

17%

Serum amylase increased

17%

Urinary frequency

Surgical and medical procedures - Other, Positive Cologuard test

Surgical and medical procedures - Other, Bilateral stent placements

Dyspnea

Infections and infestations - Other, Viral Infection

Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify

Sinus bradycardia

Nystagmus

Hypermagnesemia

CPK increased

Blood bilirubin increased

Conjunctivitis

Eye disorders - Other, Blepharitis

Colitis

Dehydration

Non-cardiac chest pain

Skin and subcutaneous tissue disorders - Other, specify

Skin and subcutaneous tissue disorders - Other, Right groin incision disorder

Surgical and medical procedures - Other, Ultrasound guided percutaneous drain for findings of left

Tooth infection

General disorders and administration site conditions - Other, sweating intermittent

Breast pain

Jejunal obstruction

Adrenal insufficiency

Skin infection

Photophobia

Blood and lymphatic system disorders - Other, Amylase increased

Gastrointestinal disorders - Other, degenerative teeth 22&27

Surgical and medical procedures - Other, BL ureteral stent exchanges- Annual

Blood and lymphatic system disorders - Other, Thrombocytopenia

Infections and infestations - Other, Herpes simplex reactivation

Surgical and medical procedures - Other, Esophagogastroduodenoscopy

Generalized muscle weakness

Cystitis noninfective

Hypomagnesemia

Myocarditis

Kidney infection

Hypernatremia

Hypothyroidism

Pruritus

Urinary tract obstruction

Chest pain - cardiac

Dry skin

Surgical and medical procedures - Other, rt nephro-ureterostomy tube exchange

Vomiting

Nervous system disorders - Other, lightness - positional standing up

Renal and urinary disorders - Other, Pyelonephritis

Flu like symptoms

Respiratory, thoracic and mediastinal disorders - Other, Cold symptoms

Hypertension

Gastrointestinal disorders - Other, Polydipsia

GGT increased

Vestibular disorder

Hematuria

Hypoglycemia

Hypotension

Glaucoma

Gynecomastia

Hypoxia

Memory impairment

Mucositis oral

Pain in extremity

Renal and urinary disorders - Other, UTI

Myositis

General disorders and administration site conditions - Other, retching, gagging

Injury, poisoning and procedural complications - Other, Abrasions left hand

Metabolism and nutrition disorders - Other, Poor appetite

Respiratory, thoracic and mediastinal disorders - Other, shortness of breath

Skin and subcutaneous tissue disorders - Other, skin rash eyes area and hands

Surgical and medical procedures - Other, left percutaneous nephrostomy

Hyperthyroidism

Back pain

Duodenal obstruction

Lung infection

Confusion

Dry eye

Sinus tachycardia

Weight loss

Bruising

Flank pain

Injury, poisoning and procedural complications - Other, Mild head injury (hit his head)

Platelet count decreased

Cataract

Surgical and medical procedures - Other, Small bowel resection

Uveitis

100%

80%

60%

40%

20%

Study treatment Arm

Lead-in Metastatic Castration-Resistant Prostate Cancer (mCRPC) Cohort

Neoadjuvant Cohort

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 12Eligibility criteria met

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.