US Pivotal Trial
and Subsequent Analyses
US Pivotal Trial
A prospective, multicenter, randomized controlled pivotal trial was performed to assess outcomes following SpaceOAR Hydrogel implantation. Spacer safety and effectiveness in consistent perirectal space creation and reduction of rectal irradiation was demonstrated.1
- T1 or T2
- Gleason Score ≤ 7
- PSA ≤ to 20ng/mL
- < 50% positive cores
- Randomized parallel arm
- 222 patients
- Randomized 2:1 (Spacer: control)
- 20 U.S. Sites
- General (36.4%)
- Local (31.4%)
- MAC (26%)
- Prophylactic antibiotics
- 95% of patients
- Fiducial/Spacer implant
Initial procedure results
Patients had approximately 13 millimeters of space after SpaceOAR Hydrogel placement. Hydrogel absorption was evident during the 3-month imaging. 1
|Week prior to 3-month date
|Week after 3-month date
|12.6 ± 3.9 mm||10.9 ± 5.8 mm||6.8 ± 5.4 mm
• 99% (gel present)
• 99% of appliers rated the procedure easy or very easy
• No device-related adverse events
• No delays to onset of IMRT
• No implant infections
• No rectal infections or complications
• 10% with mild transient procedure events
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At 3 years, more men potent at baseline and treated with SpaceOAR Hydrogel had erections sufficient for intercourse.3
Patients receiving SpaceOAR Hydrogel reported significantly favorable outcomes relating to erection ability, orgasm ability, erection quality and erection frequency.3
The use of SpaceOAR Hydrogel decreased dose to the penile bulb (11 vs 21 Gy, P <.05), which was associated with improved erectile function compared with the control group based on patient-reported sexual QOL.
- Mariados N, Sylvester J, Shah D, et al. Hydrogel spacer prospective multicenter randomized controlled pivotal trial: dosimetric and clinical effects of perirectal spacer application in men undergoing prostate image guided intensity modulated radiation therapy. Int J Radiat Oncol Biol Phys. 2015 Aug 1;92(5):971-7.
- Hamstra DA, Mariados N, Sylvester J, et al. Continued benefit to rectal separation for prostate radiation therapy: final results of a phase III trial. Int J Radiat Oncol Biol Phys. 2017 Apr;97(5):976-85.
- Hamstra DA, Mariados N, Sylvester J, et al. Sexual quality of life following prostate intensity modulated radiation therapy (IMRT) with a rectal/prostate spacer: Secondary analysis of a phase 3 trial. Pract Radiat Oncol. 2018;8(1):e7-e15.
CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings, and instructions for use can be found in the product labelling supplied with each device or at www.IFU-BSCI.com. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. This material not intended for use in France.
SpaceOAR and SpaceOAR Vue Hydrogels are intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of SpaceOAR and SpaceOAR Vue Hydrogels to reduce the radiation dose delivered to the anterior rectum.
SpaceOAR and SpaceOAR Vue Hydrogels contain polyethylene glycol (PEG). SpaceOAR Vue Hydrogel contains iodine.
Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions and potential adverse events.
As with any medical treatment, there are some risks involved with the use of SpaceOAR and SpaceOAR Vue Hydrogels. Potential complications associated with SpaceOAR and SpaceOAR Vue Hydrogels include, but are not limited to: pain associated with SpaceOAR and SpaceOAR Vue Hydrogels injection, pain or discomfort associated with SpaceOAR and SpaceOAR Vue Hydrogels, local inflammatory reactions, infection (including abscess), urinary retention, urgency, constipation (acute, chronic, or secondary to outlet perforation), rectal tenesmus/muscle spasm, mucosal damage, ulcers, fistula, perforation (including prostate, bladder, urethra, rectum), necrosis, allergic reaction (localized or more severe reaction, such as anaphylaxis), embolism (venous or arterial embolism is possible and may present outside of the pelvis, potentially impacting vital organs or extremities), syncope and bleeding. The occurrence of one or more of these complications may require treatment or surgical intervention. URO-989811-AB.
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