Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03899987 | Aspirin and Rintatolimod With or Without Interferon-alpha 2b in Treating Patients With Prostate Cancer Before Surgery | PHASE2 | ACTIVE NOT_RECRUITING | 12 | — | — | Nov 29, 2019 | Apr 30, 2027 | May 5, 2026 | 1 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| Arm I (EC aspirin, interferon alpha, rintatolimod, surgery) | EXPERIMENTAL | 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.. |
| Arm II (EC aspirin, rintatolimod, surgery) | EXPERIMENTAL | 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. |
| Arm III (radical prostatectomy) | ACTIVE_COMPARATOR | Patients undergo radical prostatectomy about 4 weeks after enrollment. |
| Name | Type | Description |
|---|---|---|
| EC Aspirin | DRUG | Given PO |
| Radical Prostatectomy | PROCEDURE | Undergo radical prostatectomy |
| Recombinant Interferon Alfa-2b | BIOLOGICAL | Given IV |
| Rintatolimod | DRUG | Given IV |
Inclusion Criteria: * Histologically confirmed, localized prostate adenocarcinoma patients who are planning to have a radical prostatectomy. * Diagnostic prostate biopsy must have been obtained within 6 months patients who had biopsies at outside facilities may be eligible if tissue availability an...