Clinical Trial

Aspirin and Rintatolimod With or Without Interferon-alpha 2b in Treating Patients With Prostate Cancer Before Surgery

Active, Not Recruiting Phase 2
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Summary
This phase II trial studies how well enteric-coated (EC) aspirin and rintatolimod with or without interferon-alpha 2b work in treating patients with prostate cancer before surgery. EC Aspirin may help to keep the prostate cancer from coming back. Rintatolimod may stimulate the immune system and interfere with the ability of tumor cells to grow and spread. Interferon-alpha 2b may improve the body's natural response to infections and may slow tumor growth. It is not yet known how well rintatolimod, EC aspirin, and interferon-alpha 2b work in treating patients with prostate cancer undergoing surgery.
Protocol Amendment History 28 amendments
This ClinicalTrials.gov record has been amended 28 times since 2019-04-01; most recent amendment 2026-06-08.
Status change: Recruiting → Active, Not Recruiting 2025-08-26
Status change: Suspended → Recruiting 2025-04-14
Status change: Recruiting → Suspended 2023-02-02
Status change: Not Yet Recruiting → Recruiting 2019-12-02
Trial Details
NCT Number NCT03899987
Lead Sponsor Roswell Park Cancer Institute
Collaborators: AIM ImmunoTech Inc.
Conditions Prostate Adenocarcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage IIA Prostate Cancer AJCC v8, Stage IIB Prostate Cancer AJCC v8, Stage IIC Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8 +2 more
Enrollment 12 participants
Start Date 2019-11-29
Primary Completion 2027-04-30 (estimated)
Study Completion 2027-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-09