Aspirin + Rintatolimod ± Interferon-alpha 2b for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Roswell Park Cancer Institute

Must not be taking: Immunosuppressants, Steroids, NSAIDs, others

Disqualifiers: Active prostatitis, Autoimmune disease, Metastatic disease, Cardiac risk, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 3-4 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

If you are taking systemic immunosuppressive agents or NSAIDs (nonsteroidal anti-inflammatory drugs), you will need to stop them before joining the trial. For NSAIDs, you can join if you agree to stop taking them, and no specific waiting period is required.

What data supports the effectiveness of the drug combination of Aspirin, Rintatolimod, and Interferon-alpha 2b for prostate cancer?

Research suggests that aspirin may help reduce the risk of prostate cancer progression and recurrence, and improve survival rates. It works by reducing inflammation, which is often linked to cancer growth. This could make aspirin a useful addition to other prostate cancer treatments. ^{1 2 3 4 5}

Is the combination of Aspirin, Rintatolimod, and Interferon-alpha 2b generally safe for humans?

Aspirin is widely used and generally considered safe for reducing inflammation and preventing heart-related events, with some studies suggesting it may also help in prostate cancer treatment. Interferon-alpha 2b has been used in cancer treatments, but it can have side effects like flu-like symptoms. There is limited specific safety data on Rintatolimod for prostate cancer, but it has been studied for other conditions. ^{1 2 5 6 7}

How is the drug Rintatolimod combined with aspirin unique for treating prostate cancer?

This treatment is unique because it combines Rintatolimod, an immune system booster, with aspirin, which has anti-inflammatory properties that may help prevent prostate cancer progression. The combination aims to enhance the body's immune response while reducing inflammation, potentially improving outcomes for prostate cancer patients. ^{1 2 3 8 9}

Research Team

Gurkamal S Chatta

Principal Investigator

Roswell Park Cancer Institute

Eligibility Criteria

This trial is for men with localized prostate adenocarcinoma who are planning surgery. They must have had a biopsy within the last 6 months, be relatively healthy (ECOG status of 0 or 1), and have normal blood counts and liver function tests.

Inclusion Criteria

I have prostate cancer and am planning to undergo surgery to remove my prostate.

My prostate biopsy was done within the last 6 months.

I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive EC aspirin, rintatolimod, and possibly interferon-alpha 2b before undergoing radical prostatectomy

3-4 weeks

Multiple visits for IV administration and surgery

Surgery

Participants undergo radical prostatectomy

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Aspirin
• Recombinant Interferon Alfa-2b
• Rintatolimod

Trial Overview The study is testing if EC Aspirin and Rintatolimod, with or without Interferon-alpha 2b, can prevent prostate cancer from returning when given before surgery. It's unclear how well these treatments work together to treat patients undergoing prostatectomy.

Participant Groups

Group I: Arm II (EC aspirin, rintatolimod, surgery) Experimental Treatment 3 Interventions

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.

Group II: Arm I (EC aspirin, interferon alpha, rintatolimod, surgery) Experimental Treatment 4 Interventions

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..

Group III: Arm III (radical prostatectomy) Active Control 1 Intervention

Patients undergo radical prostatectomy about 4 weeks after enrollment.

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

AIM ImmunoTech Inc.

Industry Sponsor

Trials

15

Recruited

710+

References

1. Greece pubmed.ncbi.nlm.nih.gov

Aspirin in the Management of Patients with Prostate Cancer Undergoing Radiotherapy: Friend or Foe? [2018]

2. England pubmed.ncbi.nlm.nih.gov

The multiple effects of aspirin in prostate cancer patients. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Regular aspirin use and gene expression profiles in prostate cancer patients. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Use of Aspirin and Statins in Relation to Inflammation in Benign Prostate Tissue in the Placebo Arm of the Prostate Cancer Prevention Trial. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Use of Low-Dose Aspirin and Mortality After Prostate Cancer Diagnosis: A Nationwide Cohort Study. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Impact of aspirin on clinical outcomes for African American men with prostate cancer undergoing radiation. [2022]

7. Japan pubmed.ncbi.nlm.nih.gov

[5-Fluorouracil and alpha-2a interferon in patients with hormone-refractory prostate cancer]. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Aspirin, NSAIDs, and risk of prostate cancer: results from the REDUCE study. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Use of non-steroidal anti-inflammatory drugs and prostate cancer survival in the Finnish prostate cancer screening trial. [2022]