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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01538628 | SpaceOAR System Pivotal Study | PHASE3 | COMPLETED | 222 | — | — | Jan 1, 2012 | Jul 1, 2014 | Mar 19, 2021 | 20 | United States |
Measurements calculated and documented by the Core Lab. Measurements performed with the Core Lab blinded to subject identification. Results based on the Core Lab computation are considered as primary.
The primary safety endpoint was the occurrence of Grade 1 or greater rectal adverse events or procedure adverse events in the 6 months following the Index Procedure. The numbers reflect the percent of subjects in each arm/group that experienced grade 1 or greater rectal or procedure adverse events post index procedure.
| Arm | Type | Description |
|---|---|---|
| SpaceOAR | EXPERIMENTAL | Men meeting the study eligibility criteria will be scheduled for fiducial marker placement using a transperineal approach with ultrasound guidance. Following successful fiducial marker placement, subjects will be randomized (2:1) to the treatment group or control group. Subjects randomized to the treatment group will undergo placement of 10 mL of SpaceOAR hydrogel |
| Control | NO_INTERVENTION | Men meeting the study eligibility criteria will be scheduled for fiducial marker placement using a transperineal approach with ultrasound guidance. Following successful fiducial marker placement, subjects will be randomized (2:1) to the treatment group or control group. Subjects randomized to the control group will not receive injection of the SpaceOAR hydrogel. |
| Name | Type | Description |
|---|---|---|
| SpaceOAR System | DEVICE | Fiducial marker placement followed by randomization to treatment group, i.e., 10mL SpaceOAR hydrogel injection, or control group, i.e., no injection of SpaceOAR hydrogel. |
Inclusion Criteria: * Subjects greater than 18 years old * Subjects must have pathologically confirmed invasive adenocarcinoma of the prostate and must be planning to undergo IMRT * Subjects must have clinical stage T1 or T2 as determined from a biopsy taken within 6 months of the baseline/screenin...