A Phase 2 interventional study of EC Aspirin and Radical Prostatectomy in Prostate Adenocarcinoma, Stage I Prostate Cancer AJCC v8 and Stage II Prostate Cancer AJCC v8, sponsored by Roswell Park Cancer Institute. Active, not recruiting at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-09.
Sponsored by Roswell Park Cancer Institute · Phase 2, Interventional, and Treatment
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.
PRIMARY OBJECTIVES:
I. Assess the immunomodulatory effectiveness of the combination of rintatolimod and EC aspirin with or without recombinant interferon alfa-2b (interferon [IFN]-alpha), in participants with localized prostate cancer undergoing radical prostatectomy.
SECONDARY OBJECTIVES:
I. Assess the safety and toxicity of the treatment combinations in participants with localized prostate cancer undergoing radical prostatectomy.
II. Assess the antitumor activity between treatment arms.
EXPLORATORY OBJECTIVES:
I. Compare the resected tumor tissue specimen and surrounding tissue samples of both study arms (pre versus [vs] post-chemokine modulatory [CKM] treatment, with vs without CKM, CKM doublet vs CKM triplet) with regards to infiltrating T cell subtypes, effector T cell (Teff)/regulatory T cell (Treg) ratios, CD11b+ myeloid-derived suppressor cell (MDSC); the expression of chemokine receptors and immune checkpoint molecules on immune cells; local expression of Teff-attracting chemokines and Treg/MDSC-favoring chemokines; ribonucleic acid (RNA) signatures of groups of immune-regulatory genes that are modulated by the CKM regimen.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I: Patients receive EC aspirin orally (PO) two times a day (BID) from day -7 to 7 days prior to surgery. Patients also receive recombinant interferon alfa-2b intravenously (IV) over 20 minutes and rintatolimod IV over 2 hours on days 1-3, and 8-10 in the absence of disease progression or unacceptable toxicity. Patients then undergo radical prostatectomy on or between day 17-24.
ARM II: Patients receive EC aspirin PO BID from day -7 to 7 days prior to surgery and rintatolimod IV over 2 hours on days 1-3 and 8-10 in the absence of disease progression or unacceptable toxicity. Patients then undergo radical prostatectomy on or between day 17-24.
ARM III: Patients undergo radical prostatectomy about 4 weeks after enrollment.
After completion of study treatment, patients are followed up at 30 days.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 12 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Roswell Park Cancer Institute is the lead sponsor of 412 studies on the registry; 62 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 21 (55%) have results posted.
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Exclusion Criteria:
Cardiac risk factors including:
Patients receive aspirin PO BID on days -7 to 7. Patients also receive recombinant interferon alfa-2b IV over 20 minutes and rintatolimod IV over 2 hours on days 1-3 and 8-10 in the absence of disease progression or unacceptable toxicity. Patients then undergo radical prostatectomy on or between day 17-24..
Drug: EC Aspirin · Procedure: Radical Prostatectomy · Biological: Recombinant Interferon Alfa-2b · Drug: Rintatolimod
Patients receive aspirin PO BID on days -7 to 7 and rintatolimod IV over 2 hours on days 1-3,and 8-10 in the absence of disease progression or unacceptable toxicity. Patients then undergo radical prostatectomy on or between day 17-24.
Drug: EC Aspirin · Procedure: Radical Prostatectomy · Drug: Rintatolimod
Patients undergo radical prostatectomy about 4 weeks after enrollment.
Procedure: Radical Prostatectomy
Given PO
Also known as: Acetylsalicylic Acid, ASA, Aspergum, aspirin, Ecotrin, Empirin, Entericin, Extren, Measurin, Enteric-coated aspirin
Undergo radical prostatectomy
Also known as: Prostatovesiculectomy
Given IV
Also known as: Alfatronol, Glucoferon, Heberon Alfa, IFN alpha-2B, Interferon alfa 2b, Interferon Alfa-2B, Interferon Alpha-2b, Intron A, Sch 30500, Urifron, Viraferon
Given IV
Also known as: Ampligen, Atvogen
Count of tumor infiltrating CD8+ lymphocytes
This will be assessed by the increase in the total number of tumor infiltrating CD8+ T cells in the radical prostatectomy specimen (measured as cell density of CD8+ cell by immunohistochemistry), comparing Arm A versus Arm B versus Arm C. Will be natural log transformed prior to analysis. The primary analysis will consist of testing the single degree of freedom planned contrast at alpha = .10 that the 3 treatment means are in the ratio of 3:2:1 (contrast coefficients 3, -2, -1) for groups A, B and C, respectively groups. If this test rejects the null hypothesis of no group differences, will proceed to estimate group means and pairwise differences between groups with 90% confidence intervals. Non-overlapping confidence intervals will serve as evidence of differential treatment effects.
Time frame: Up to 3 years
Pathologic response
Spearman rank correlation coefficients will be used to estimate the correlation between CD8+ tumor infiltrate, pathologic response rate and prostate specific antigen (PSA) response.
Time frame: Up to 3 years
Number of patients with Surgical margin positivity
Time frame: Up to 3 years
PSA response
Spearman rank correlation coefficients will be used to estimate the correlation between CD8+ tumor infiltrate, pathologic response rate and PSA response.
Time frame: Up to 3 years
Incidence of treatment-related adverse events
Will be evaluated with National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
Time frame: Up to 30 days post treatment
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Roswell Park Cancer Institute