Approval Probability
TA Base Rate
Adjusted LOA
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SpaceOAR System · 1 trial · 1 indication
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...
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SpaceOAR System is used for prostate cancer. It is a hydrogel spacer that is injected between the prostate and the rectum to create space during radiation therapy, which may help reduce radiation exposure to the rectum. It is currently in clinical development for this indication.
SpaceOAR System is developed by Boston Scientific Corporation, a company traded on the New York Stock Exchange under the ticker BSX. The company is conducting clinical trials to evaluate the device for use in prostate cancer patients.
SpaceOAR System is in Phase 3 clinical development. It has completed a Phase 3 pivotal study, and it remains an investigational product. It is not yet approved by the FDA, as it is still undergoing clinical evaluation for prostate cancer.
SpaceOAR System has one completed Phase 3 clinical trial, identified as NCT01538628, titled "SpaceOAR System Pivotal Study." This trial enrolled 222 male participants aged 18 years and older with prostate cancer in the United States. The trial was randomized and had a no-treatment control group.
SpaceOAR System is a distinct product developed by Boston Scientific Corporation. It is a hydrogel spacer designed for use in prostate cancer radiation therapy. No alternative names for this product have been established in the available clinical trial information.