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

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv29
  2. Primary completion date: Jun 12, 2025 to Apr 30, 2027
    • Study completion date: Nov 29, 2026 to Apr 30, 2027
    v28
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 30 to confirmed 12
    • Primary completion date changed from estimate of Nov 29, 2026 to Jun 12, 2025
    • Site details revised
    v27
  4. Trial status: Suspended to Recruitingv26 Show 4 more changesShow less
    • Primary and study completion dates: May 29, 2026 to Nov 29, 2026
    • Interventions: Aspirin (Drug), Radical Prostatectomy (Procedure), Recombinant Interferon Alfa-2b (Biological), Rintatolimod (Drug) to EC Aspirin (Drug), Radical Prostatectomy (Procedure), Recombinant Interferon Alfa-2b (Biological), Rintatolimod (Drug)
    • Site details revised
    • Study description expanded, about 3 words
  5. Primary and study completion dates: May 29, 2024 to May 29, 2026v25
Show 23 earlier versionsHide 23 earlier versions
  1. Primary completion date: Nov 29, 2023 to May 29, 2024
    • Study completion date: Nov 29, 2024 to May 29, 2024
    v24
  2. Sponsor's reason: Drug supply issue to IFNa2b Supply Shortagev23
  3. Trial status: Recruiting to Suspended Sponsor's reason: Drug supply issue
    • Enrollment target: 45 to 30
    • Site details revised
    v22
  4. Primary completion date: Nov 29, 2022 to Nov 29, 2023
    • Study completion date: Nov 29, 2023 to Nov 29, 2024
    v21
  5. Collaborators: 2 to 1v20
  6. Primary completion date: Apr 2, 2022 to Nov 29, 2022
    • Study completion date: Apr 2, 2023 to Nov 29, 2023
    v19
  7. Primary completion date: Jan 2, 2022 to Apr 2, 2022
    • Study completion date: Jan 2, 2023 to Apr 2, 2023
    v18
  8. Eligibility criteria expanded, about 10 wordsv17
  9. Eligibility criteria shortened, about 3 wordsv16
  10. Re-verified, no change to tracked fieldsv15
  11. Study description revisedv14
  12. Study description shortened, about 2 wordsv13
  13. Re-verified, no change to tracked fieldsv12
  14. Enrollment target: 60 to 45
    • Eligibility criteria expanded, about 7 words
    v11
  15. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 2, 2020 to Nov 29, 2019
    • Site details revised
    v10
  16. Start date: Nov 1, 2019 to Jan 2, 2020v9
  17. Start date: Sep 1, 2019 to Nov 1, 2019v8
  18. Start date: Aug 1, 2019 to Sep 1, 2019v7
  19. Start date: Jun 1, 2019 to Aug 1, 2019v6
  20. Collaborators: 1 to 2v5
  21. Start date: May 1, 2019 to Jun 1, 2019v4
  22. Start date: Apr 1, 2019 to May 1, 2019v3
  23. Secondary endpoints revised (4)v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03899987
Lead Sponsor Roswell Park Cancer Institute
Collaborators: AIM ImmunoTech Inc.
Conditions
(from sponsor)		 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 +2 more
Related terms Prostatic Neoplasms
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov