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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02250014 | The Immuno-Response to Primary Cryotherapy for the Treatment of Prostate Cancer | PHASE1 | COMPLETED | 19 | — | — | Oct 5, 2015 | Dec 21, 2020 | Feb 9, 2022 | 1 | United States |
A scatter plot of each cytokine and antigen level will be created for each patient by marker to observe the behavior of the markers (rising, falling, flat, or combination over time). Patient specific pre-operative levels will be used to obtain individual baseline measures from which the difference in follow-up cytokine and antigen levels will be calculated, then a simple descriptive comparison of the mean elevation in the markers' levels across cohorts will be graphed.
A scatter plot of each cytokine and antigen level will be created for each patient by marker to observe the behavior of the markers (rising, falling, flat, or combination over time). Patient specific pre-operative levels will be used to obtain individual baseline measures from which the difference in follow-up cytokine and antigen levels will be calculated, then a simple descriptive comparison of the mean elevation in the markers' levels across cohorts will be graphed.
| Arm | Type | Description |
|---|---|---|
| Arm I (cryotherapy, sargramostim) | EXPERIMENTAL | Patients undergo cryotherapy on day 0 and receive sargramostim subcutaneously on days 1, 3, 5, 8, 10, and 12. |
| Arm II (cryotherapy, standard of care) | ACTIVE_COMPARATOR | Patients undergo cryotherapy on day 0. |
| Name | Type | Description |
|---|---|---|
| cryotherapy | PROCEDURE | Undergo cryotherapy |
| sargramostim | BIOLOGICAL | Given subcutaneously |
Inclusion Criteria: * Patients diagnosed with prostate cancer that elect to undergo primary cryotherapy of the prostate * Patients who are diagnosed with clinical stage T1a -T2c prostate cancer * Gleason score sum of less than or equal to 7 * Prostate-specific antigen (PSA) \< 20 ng/dl * Patient wi...