Hydrogel Technology

Hydrogel Prostate Cancer Radiotherapy Technology Enabling Improved Planning And Outcomes

SpaceOAR hydrogel is the first absorbable hydrogel spacer designed to reduce unintentional rectal injury in men undergoing prostate radiotherapy (RT). Using ultrasound guidance, the hydrogel is administered as a liquid that expands the space between Denonvilliers’ fascia and the rectal wall, where it solidifies into a soft, but firm, hydrogel within 10 seconds. The hydrogel remains in place for three months during prostate radiotherapy, after which it liquefies by hydrolysis, and is naturally absorbed and cleared in the patient’s urine.

Learn Why Leading Clinical Oncologists, Urologists and Dosimetrists are Using SpaceOAR Hydrogel

 Minimally Invasive. Implanted with one 18G needle, it does not require a surgical scalpel or dilator. SpaceOAR can be inserted with general or local anaesthesia, facilitating a day case procedure.1

 Consistent Spacing. SpaceOAR is a soft hydrogel that creates on average over 1cm of space for the duration of radiotherapy.2

 Clinically Proven. SpaceOAR is the only hydrogel marketed to create space between the prostate and rectum for men with prostate cancer receiving radiation. It is available in the United Kingdom and a growing number of European and International markets.

 Clinically Supported. Our team of dedicated international clinical specialists provide clinicians with application training through a certification programme.

“SpaceOAR hydrogel creates a greater distance between the prostate tumour and other tissues, enabling us to concentrate the radiotherapy dosage provided to the tumour and reduce the chance of radiation harming other tissues close to the prostate such as the bowel.” – Dr Suneil Jain, Honorary Consultant in Clinical Oncology, Queen’s University Belfast.

Before SpaceOAR hydrogel Placement

After SpaceOAR hydrogel Placement

In order to assess SpaceOAR hydrogel safety and effectiveness a prospective, randomized, controlled, patient-blinded clinical study was performed in the United States. In 20 centers a total of 222 men were randomized to receive fiducial marker and SpaceOAR hydrogel injection, or fiducial markers alone (control group). Patients then received 79.2Gy x 44 fraction IG-IMRT, and were followed weekly during RT, and at 3, 6, 12 and 15 months.

SpaceOAR has now been featured in over 60 clinical publications.

SpaceOAR Hydrogel Clinical Trial Results

Prostate-Rectal Space Pre-implant: 1.6 mm
Post-implant: 12.6 mm
Procedure Success 99% Technical Success (gel present)
Rectal V70 Dose
(average)
Pre-SpaceOAR Hydrogel: 12.4%
Post-SpaceOAR Hydrogel: 3.3%
Acute Rectal Pain AE’s
(3 mo)
Control Group: 11.1%
SpaceOAR Hydrogel Group: 2.7%
Late Rectal Toxicity
(1 year post RT)
Control Group: 7% (Max G3*)
SpaceOAR Hydrogel Group: 2% (Max G1)
Bowel QOL (EPIC)
% Patients with >10pt decline (15 mo)
Control Group: 21.4%
SpaceOAR Hydrogel Group: 11.6%

* Key:
Grade 1 (G1): Mild, transient
Grade 2 (G2):Moderate, requiring prescription medication
Grade 3 (G3): Additional procedure required for treatment

Reference: http://www.redjournal.org/article/S0360-3016(15)00430-7/pdf

Please see Instructions for Use for a complete list of potential risks, warnings and precautions.

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1. Montoya J, Gross E, Karsh L. How I Do It: Hydrogel spacer placement in men scheduled to undergo prostate radiotherapy. Can J Urol 2018; 25(2):9288-9293.
2. Mariados N, 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. International Journal of Radiation Oncology Biology and Physics (2015); 92(5): 971-977