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

NCT03899987 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-05-05

No results posted yet for this study

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.

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
  • Stage IIIB Prostate Cancer AJCC v8
  • Stage IIIC Prostate Cancer AJCC v8

Interventions

DRUG

EC Aspirin

Given PO

PROCEDURE

Radical Prostatectomy

Undergo radical prostatectomy

BIOLOGICAL

Recombinant Interferon Alfa-2b

Given IV

DRUG

Rintatolimod

Given IV

Sponsors & Collaborators

Principal Investigators

  • Gurkamal S Chatta · Roswell Park Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-29
Primary Completion
2027-04-30
Completion
2027-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03899987 on ClinicalTrials.gov