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NCT03899987Active, not recruitingPhase 2

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

Randomized Phase 2 Study: Neoadjuvant Conditioning of Prostate Cancer Tumor Microenvironment Using a Novel Chemokine-Modulating Regimen

Source: ClinicalTrials.gov · Last updated 9 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
12 (actual)
First submitted
15 Mar 2019
Start date
29 Nov 2019
Primary completion date
30 Apr 2027
Lead sponsor
Roswell Park Cancer Institute
NCT number
NCT03899987

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 12
  • From 29 Nov 2019 to the primary completion date, 30 Apr 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • Prior allergic reaction or hypersensitivity to aspirin, or other nonsteroidal antiinflammatory drugs (NSAIDs).

Other illness

  • 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).
  • 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.
  • Any condition which in the investigator?s opinion deems the participant an unsuitable candidate to receive study drug.

Other

  • Patients with active prostatitis.
  • 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.
  • Unwilling or unable to follow protocol requirements.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Roswell Park Cancer Institute
Coordinator of this site? Confirm its status
BuffaloUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.