Aspirin and immune boosters could help fight prostate cancer before surgery
NCT ID NCT03899987
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests whether giving a combination of enteric-coated aspirin, rintatolimod, and interferon-alpha 2b before prostate cancer surgery can boost the immune system's attack on tumors. The study involves 12 men with localized prostate cancer who are scheduled for surgery. The main goal is to see if these drugs increase cancer-fighting immune cells in the tumor.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- enteric-coated aspirin, rintatolimod, and interferon-alpha 2b
- What this could lead to
- If successful, this could point toward a new pre-surgery treatment that helps the immune system fight prostate cancer and lowers the chance of it coming back.
- What could go wrong
- This is a very small early-phase trial with only 12 participants, so results may not apply broadly. The drugs may cause side effects like flu-like symptoms or bleeding risks from aspirin.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
12 people
The number who actually took part.
- Started
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Nov 2019
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologically confirmed, localized prostate adenocarcinoma patients who are planning to have a radical prostatectomy. * Diagnostic prostate biopsy must have been obtained within 6 months patients who had biopsies at outside facilities may be eligible if tissue availability and adequacy can be confirmed by pathology. * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Platelet \>= 75,000/uL. * Hemoglobin \>= 9 g/dL. * Hematocrit \>= 27%. * Absolute neutrophil count (ANC) \>= 1500/uL. * Creatinine \< institutional upper limit of normal (ULN) OR creatinine clearance \>= 50 mL/min for patients with creatinine levels greater than ULN. * Total bilirubin =\< 1.5 X institutional ULN. * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 1.5 X institutional ULN. * Serum amylase and lipase =\< 1.5 X institutional ULN. * Negative hepatitis panel for patients with a history of Hepatitis * Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure. Exclusion Criteria: * Patients currently treated with systemic immunosuppressive agents, including steroids, are ineligible until 3 weeks after removal from immunosuppressive treatment. * Patients who received hormonal therapy, 5-alpha reductase inhibitors (such as finasteride, dutasteride), chemotherapy, radiotherapy, major surgery, or biologic therapy within 3 weeks of protocol treatment. * Patients with active prostatitis. * Patients with active autoimmune disease or history of transplantation. * Patients with comorbid medical conditions that render them unfit for surgery. * Metastatic disease based on preoperative imaging. * Cardiac risk factors including: * Patients experiencing cardiac event(s) (acute coronary syndrome, myocardial infarction, or ischemia) within 3 months of signing consent * Patients with a New York Heart Association classification of III or IV. * History of upper and lower gastrointestinal ulceration, upper gastrointestinal bleeding, or perforation within the past 3 years. * History of bleeding disorders, known lesions at risk for bleeding, or history of recent clinically significant bleed or hemorrhage (\<3months). * Prior allergic reaction or hypersensitivity to aspirin, or other nonsteroidal antiinflammatory drugs (NSAIDs). * Patients are ineligible if they plan on use of other NSAIDs at any dose during the trial. Patients who agree to stop regular NSAIDs are eligible and no wash out period is required. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Unwilling or unable to follow protocol requirements. * Any condition which in the investigator?s opinion deems the participant an unsuitable candidate to receive study drug.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
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Other studies related to the condition(s) this trial covers.
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