Proposed Hydrogel-Implant Quality Score and a Matched-Pair Study for Prostate Radiation Therapy

SpaceOAR hydrogel has been Food and Drug Administration approved to reduce rectal toxicity in prostate radiation therapy. Training and certification for this procedure is performed by the manufacturer, without independent quality measures. We propose a Hydrogel-Implant Quality Score (HIQS) as a surrogate to quantify hydrogel placement accuracy, to assist clinicians in tracking their implant proficiency, and to support quality improvement. A matched-pair study was designed to investigate the benefit of SpaceOAR in rectal dose reduction for low-dose-rate brachytherapy and to validate the principle of the proposed HIQS.

Eighty-one prostate patients were retrospectively selected for this study. Each patient had SpaceOAR implantation under manufacturer supervision. Postprocedure computed tomography and T2-weighted magnetic resonance imaging were acquired for radiation planning. A HIQS system was proposed to evaluate the hydrogel placement quality. Hydrogel implantation was performed immediately after LDR seed placement. For each LDR patient, a non-SpaceOAR patient was matched based upon intraoperative rectal dose and prostate coverage. Intraoperative and postoperative rectal dose reduction was compared between SpaceOAR and non-SpaceOAR groups.

The average HIQS was 77 ± 10.8 (range, 49-97). Rectal anatomic distortions were seen in 17 cases. Significant rectal dose reductions between intraoperative and postoperative plans were found for SpaceOAR patients compared with non-SpaceOAR patients (25.1 Gy vs -5.0 Gy for ΔD_2cc and 65.7 Gy vs 13.0 for ΔD_0.1cc). Additional rectal dose reductions (8.4 Gy for ΔD_2cc and 12.7 Gy for ΔD_0.1cc) were found for patients without rectal distortion when SpaceOAR was used.

The proposed HIQS system measured the hydrogel placement quality and provided insights into clinician learning and DVH outcome. SpaceOAR was shown to be effective in reducing rectal dose for LDR patients.