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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00274287 | GM-CSF for Maintenance of Prostate Cancer for Patients Responding to Taxotere | PHASE2 | COMPLETED | 15 | — | — | Jan 1, 2006 | Dec 1, 2010 | Mar 28, 2019 | 1 | United States |
The primary end point of this study is to evaluate time to disease progression (TTP). TTP is defined as the time from starting taxotere until there is evidence of progressive disease (PD) as defined below (radiographically and/or biochemically). PD was defined as more than 20% in the sum of longest diameter of measurable lesions compared to baseline, and/or evidence of new lesions on imaging studies. Median TTP from GM-CSF administration and Median TTP from start of chemotherapy is being reported
| Arm | Type | Description |
|---|---|---|
| GM-CSF | EXPERIMENTAL | Once patients have finished receiving the chemotherapy and no signs of disease progression they may receive GM-CSF as outlined in the protocol |
| Name | Type | Description |
|---|---|---|
| GM CSF | DRUG | 250 ug/m2 daily for 2 weeks followed by 2 weeks of rest |
Inclusion Criteria: 1. Men \>18 years of age. No upper age limit 2. Written informed consent approved by institutional review board should be explained to and signed by patient 3. Documentation of histologically confirmed adenocarcinoma of the prostate. Gleason score of any sum is allowed on this s...