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sargramostim · 1 trial · 4 indications
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...
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Sargramostim is being studied for use in recurrent prostate cancer, specifically in the context of primary cryotherapy treatment. It is an investigational monoclonal antibody being evaluated in a Phase 1 clinical trial for patients with recurrent prostate cancer, as well as Stage I and Stage IIA/IIB prostate cancer.
Sargramostim is being developed by EDAP TMS S.A., a company traded under the ticker FOCL. The drug is currently in Phase 1 clinical development for the treatment of recurrent prostate cancer.
Sargramostim is in Phase 1 clinical development. It is an investigational drug, not yet approved, and is being studied in a completed Phase 1 trial for recurrent prostate cancer. The trial enrolled 19 participants and was conducted in the United States.
Sargramostim has one completed clinical trial, NCT02250014, titled "The Immuno-Response to Primary Cryotherapy for the Treatment of Prostate Cancer." This Phase 1 trial enrolled 19 male participants aged 18 years and older with recurrent prostate cancer or Stage I, IIA, or IIB prostate cancer.
Sargramostim is a monoclonal antibody, but its specific molecular target has not been disclosed in available information. The drug is being investigated for its role in the immune response to primary cryotherapy in prostate cancer, though the exact mechanism of action is not publicly detailed.