Can a peri‐rectal hydrogel space<scp>OAR</scp> programme for prostate cancer intensity‐modulated radiotherapy be successfully implemented in a regional setting?

Velde, Bridget L te; Westhuyzen, Justin; Awad, N.; Wood, Maree; Shakespeare, Thomas P.

doi:10.1111/1754-9485.12580

Cited by 13 publications

(35 citation statements)

References 16 publications

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“…Reducing radiation dose to the rectum and other OARs during IMRT is desirable for reducing potential toxicities associated with radiotherapy treatment of the prostate. In an earlier study, we reported that SpaceOAR insertion was of benefit to patients during radiotherapy treatment for both the dose‐volume histogram (DVH) and acute CTCAE scores, particularly in relation to acute diarrhoea . The present study has demonstrated that SpaceOAR is of benefit for reducing the cumulative incidence of low‐grade diarrhoea (grade G1); P = 0.016) and proctitis (grades G1 and G2; P = 0.015) for up to 3 years after radiotherapy.…”

Section: Discussionsupporting

confidence: 51%

“…As in the earlier evaluation, a total of 125 patients treated between April 2014 and June 2015 were reviewed; 121 patients were included in the late toxicity analysis. There were no differences in patient characteristics between the groups (age, body weight, initial PSA, prostate volume, ADT use and median Gleason score (Table ).…”

Section: Resultsmentioning

confidence: 99%

“…The characteristics of the patients have been described 7 ; planning and treatment procedures included MRI fusion for all patients and have been described in detail. [7][8][9] Eligible patients presented with intact, radical prostate cancer, clinical stage T1-T3. SpaceOAR was offered to all patients at the initial consultation; insertion was performed by the referring urologist using a transperineal method.…”

Section: Patient Selection and Proceduresmentioning

confidence: 99%

“…SpaceOAR (Augmenix®, Waltham, MA, USA) is a polyethylene‐glycol hydrogel that is injected into the peri‐rectal space at the same time as the gold fiducial markers are implanted. A previous report from our group indicated that a SpaceOAR programme is of clinical benefit for prostate cancer patients treated with IMRT as it is associated with significantly lower radiation doses to the rectum and lower rates of acute diarrhoea during and up to 12 weeks after radiotherapy. In the present report, we aimed to determine whether the use of SpaceOAR reduces long‐term rectal toxicity in a cohort of prostate cancer patients treated with IMRT.…”

Section: Introductionmentioning

confidence: 95%

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Late toxicities of prostate cancer radiotherapy with and without hydrogel SpaceAOR insertion

et al. 2019

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Introduction To investigate whether the implantation of a hydrogel spacer (SpaceOAR) reduces long‐term rectal toxicity for prostate cancer patients treated with intensity‐modulated radiotherapy (IMRT). Methods Patients with localised prostate cancer treated with 81 Gy in 45 fx of IMRT over 9 weeks were retrospectively compared: 65 patients with SpaceOAR and 56 patients without SpaceOAR. Planning aims restricted rectal doses to V40 Gy < 35%, V65 Gy < 17%, V75 Gy < 10%. Toxicities were evaluated between 3 months and 3 years after the completion of radiotherapy and were based on the common terminology criteria for adverse events (CTCAE) assessment tool for diarrhoea, haemorrhoids, faecal incontinence and proctitis. Results The cumulative incidence of low‐grade diarrhoea (G1) was significantly higher in the non‐SpaceOAR group (21.4% vs 6.2%; P = 0.016). The cumulative incidence of proctitis (grades G1 and G2) was also higher in the non‐SpaceOAR group (26.7% vs 9.2%; P = 0.015); the cumulative incidence of G2 proctitis was higher in the latter group (P = 0.043). There were no differences between the treatment groups for cumulative incidences of faecal incontinence and/or haemorrhoids. Three years after IMRT, diarrhoea and proctitis were higher in the non‐SpaceOAR group, without reaching statistical significance. This finding was unchanged after correcting for baseline symptoms. Conclusion SpaceOAR is of benefit in reducing the cumulative incidence of low‐grade diarrhoea and proctitis for up to 3 years after intensity‐modulated radiotherapy.

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Section: Discussionsupporting

confidence: 51%

Section: Resultsmentioning

confidence: 99%

Section: Patient Selection and Proceduresmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 95%

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Late toxicities of prostate cancer radiotherapy with and without hydrogel SpaceAOR insertion

et al. 2019

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“…Our present work builds upon published studies examining the use of HS in our region . In particular, our present findings are comparable to three studies that have reported on rectal dose endpoints and toxicities (late Grade 1), and found them to be significantly lower across all patient groups, with the greatest difference observed in the higher rectal dose (rV 65–82 ) range. More recently, a study by Mariados et al , examined 222 patients who were randomised to those with HS ( n = 149) or without HS ( n = 73), whilst undergoing IMRT to a dose of 79.2 Gy in 44 fractions.…”

Section: Discussionsupporting

confidence: 87%

Prospective analysis of hydrogel spacer for patients with prostate cancer undergoing radiotherapy

Chao

Ho²,

Chan

et al. 2018

BJU International

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Association of the Placement of a Perirectal Hydrogel Spacer With the Clinical Outcomes of Men Receiving Radiotherapy for Prostate Cancer

et al. 2020

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IMPORTANCE Perirectal spacers are intended to lower the risk of rectal toxic effects associated with prostate radiotherapy. A quantitative synthesis of typical clinical results with specific perirectal spacers is limited. OBJECTIVE To evaluate the association between perirectal hydrogel spacer placement and clinical outcomes of men receiving radiotherapy for prostate cancer. DATA SOURCES A systematic search was performed of the Cochrane Central Register of Controlled Trials, MEDLINE, and Embase for articles published through September 2019.STUDY SELECTION Studies comparing men who received a hydrogel spacer vs men who did not receive a spacer (controls) prior to prostate radiotherapy. DATA EXTRACTION AND SYNTHESISVia random-effects meta-analysis, group comparisons were reported using the weighted mean difference for continuous measures and the risk ratio for binary measures. MAIN OUTCOMES AND MEASURESProcedural results, the percentage volume of rectum receiving at least 70 Gy radiation (v70), early (Յ3 months) and late (>3 months) rectal toxic effects, and early and late changes in bowel-related quality of life on the Expanded Prostate Cancer Index Composite (minimal clinically important difference, 4 points). RESULTSThe review included 7 studies (1 randomized clinical trial and 6 cohort studies) involving 1011 men (486 who received a hydrogel spacer and 525 controls), with a median duration of patient follow-up of 26 months (range, 3-63 months). The success rate of hydrogel spacer placement was 97.0% (95% CI, 94.4%-98.8% [5 studies]), and the weighted mean perirectal separation distance was 11.2 mm (95% CI, 10.1-12.3 mm [5 studies]). Procedural complications were mild and transient, occurring in 0% to 10% of patients within the studies. The hydrogel spacer group received 66% less v70 rectal irradiation compared with controls (3.5% vs 10.4%; mean difference, −6.5%; 95% CI, -10.5% to -2.5%; P = .001 [6 studies]). The risk of grade 2 or higher rectal toxic effects was comparable between groups in early follow-up (4.5% in hydrogel spacer group vs 4.1% in control group; risk ratio, 0.82; 95% CI, 0.52-1.28; P = .38 [6 studies]) but was 77% lower in the hydrogel spacer group in late follow-up (1.5% vs 5.7%; risk ratio, 0.23; 95% CI, 0.06-0.99; P = .05 [4 studies]).Changes in bowel-related quality of life were comparable between groups in early follow-up (mean difference, 0.2; 95% CI, -3.1 to 3.4; P = .92 [2 studies]) but were greater in the hydrogel spacer group in late follow-up (mean difference, 5.4; 95% CI, 2.8-8.0; P < .001 [2 studies]).

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Can a peri‐rectal hydrogel spaceOAR programme for prostate cancer intensity‐modulated radiotherapy be successfully implemented in a regional setting?

Abstract: A SpaceOAR programme in a regional setting with urologists performing low volumes of insertions (<1 per month on average) is of clinical benefit, and was associated with significantly lower radiation doses to the rectum and lower rates of acute diarrhoea.

Cited by 13 publications

References 16 publications

Late toxicities of prostate cancer radiotherapy with and without hydrogel SpaceAOR insertion

Late toxicities of prostate cancer radiotherapy with and without hydrogel SpaceAOR insertion

Prospective analysis of hydrogel spacer for patients with prostate cancer undergoing radiotherapy

Association of the Placement of a Perirectal Hydrogel Spacer With the Clinical Outcomes of Men Receiving Radiotherapy for Prostate Cancer

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