Study on Aspirin and Rintatolimod With or Without Interferon-alpha 2b for Prostate Cancer Treatment Before Surgery

Sponsor: Roswell Park Cancer Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03899987

Provider View

This clinical trial is exploring how well a combination of aspirin and rintatolimod, with or without interferon-alpha 2b, works in treating prostate cancer before surgery. The study aims to see if these treatments can help prevent the cancer from returning and improve the body's immune response against the tumor.

Patient Parameters

Program Overview

The purpose of this study is to find out if using enteric-coated (EC) aspirin and rintatolimod, with or without interferon-alpha 2b, can effectively treat prostate cancer before surgery. EC Aspirin may help prevent the cancer from coming back, while rintatolimod might boost the immune system to fight the cancer. Interferon-alpha 2b could enhance the body's natural defenses and slow down tumor growth. The study will compare different treatment combinations to see which works best for patients undergoing surgery for prostate cancer.

Description

The study is divided into three groups:

  • Group 1: Patients will take EC aspirin by mouth twice a day for 7 days before surgery. They will also receive interferon-alpha 2b and rintatolimod through an IV on specific days. Surgery will take place between days 17 and 24.

  • Group 2: Patients will take EC aspirin by mouth twice a day for 7 days before surgery and receive rintatolimod through an IV on specific days. Surgery will take place between days 17 and 24.

  • Group 3: Patients will have surgery about 4 weeks after joining the study.

After the treatment, patients will have a follow-up visit 30 days later to check on their health and the treatment's effects.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with localized prostate cancer and planning to have surgery to remove the prostate.
  • Recent prostate biopsy within the last 6 months.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Adequate blood counts and organ function as determined by specific tests.
  • No history of hepatitis or active hepatitis infection.
  • Understand the study and agree to sign a consent form before participating.

Exclusion Criteria

  • Currently taking medications that suppress the immune system, including steroids, unless stopped 3 weeks before the study.
  • Recent treatment with hormone therapy, chemotherapy, or major surgery within 3 weeks before the study.
  • Active prostate infection or prostatitis.
  • History of autoimmune disease or organ transplant.
  • Medical conditions that make surgery unsafe.
  • Cancer that has spread beyond the prostate.
  • Recent heart problems or severe heart disease.
  • History of stomach ulcers or bleeding in the past 3 years.
  • Bleeding disorders or recent significant bleeding.
  • Allergic to aspirin or other NSAIDs.
  • Unable to follow the study requirements or have conditions that make participation unsafe.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.