Placement of an absorbable rectal hydrogel spacer in patients undergoing low-dose-rate brachytherapy with palladium-103

Taggar, Amandeep; Charas, Tomer; Cohen, Gilad; Boonyawan, Keeratikarn; McBride, Sean; Mathur, Nitin; Damato, Antonio L.; Zeléfsky, Michael J.

doi:10.1016/j.brachy.2017.11.006

Cited by 36 publications

(54 citation statements)

References 34 publications

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“…As demonstrated in studies, PEG hydrogel has an excellent biocompatibility (29,30). SpaceOAR and DuraSeal (Covidien, Mansfield, MA) are two types of commercially developed PEG-based hydrogel spacer that used as prostaterectum spacer during prostate BT (18,22,24,25). In 2005, DuraSeal received U.S. Food and Drug Administration (FDA) approval as an adjunct to sutured dural repair during spinal surgery (24).…”

Section: Characteristics Of Peg Hydrogelmentioning

confidence: 99%

“…In 2005, DuraSeal received U.S. Food and Drug Administration (FDA) approval as an adjunct to sutured dural repair during spinal surgery (24). DuraSeal is used on an offlabel basis and has no FDA approval for prostate injection (24,25). On the contrary, SpaceOAR is the only product that has FDA de novo clearance for creating space between the prostate and rectum (25).…”

Section: Characteristics Of Peg Hydrogelmentioning

confidence: 99%

“…DuraSeal is used on an offlabel basis and has no FDA approval for prostate injection (24,25). On the contrary, SpaceOAR is the only product that has FDA de novo clearance for creating space between the prostate and rectum (25). In overall, PEG hydrogel is persistent up to 3 months before hydrolysis and elimination via renal filtration (24,25,31).…”

Section: Characteristics Of Peg Hydrogelmentioning

confidence: 99%

“…The DuraSeal volume clearance half-life and the separation half-life were reported 47 and 110 days, respectively (20). The PEG-hydrogel is well visualized on T2-weighted MRI (20,25,28). Space-OAR maintains stable separation up to 3 months, whereas DuraSeal is stable at 3 weeks and hydrolyzes over 4e8 weeks (17,22,24).…”

Section: Prostateerectum Separationmentioning

confidence: 99%

“…A number of reports have been reported that the implantation of hydrogel spacer was successful in all patients (17e21, 23,24,26,27). Nonetheless, some studies have found that successful prostateerectum spacing was not achieved in all patients (22,25,28). In the salvage BT setting in patients with a history of pelvic irradiation, Mahal et al (22) have reported that only in 3 of 11 cases a suitable space was not achieved owing to fibrosis and scarring.…”

Section: Prostateerectum Separationmentioning

confidence: 99%

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Optimization of prostate brachytherapy techniques with polyethylene glycol–based hydrogel spacers: A systematic review

Ardekani

Ghaffari

2020

Brachytherapy

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The objective of this overview was to critically evaluate the effect of polyethylene glycol (PEG)-based hydrogel spacers during prostate brachytherapy with regard to dosimetric and clinical benefits, as well as procedure-related toxicity. METHODS AND MATERIALS: A systematic search in the PubMed database was performed. RESULTS: A total of 12 studies, involving 615 patients with PEG hydrogel injection, were included. Overall, patients well tolerated the implantation of PEG hydrogel spacers with an excellent safety profile. However, although there were some procedure-related complications, rates of these complications were very rare. Toxicities related to the spacer were limited to Grade 1 rectal discomfort and pain (9/615 patients), Grade 2 rectal ulceration (1 in 615 patients), perineal abscess (1 in 615 patients), and bacterial prostatitis (2/615 patients) according to Common Terminology Criteria for Adverse Events v4.0 grading scheme. The application of PEG hydrogel spacers significantly reduced radiation doses to the rectum during prostate brachytherapy in the different setting. Although there was no prospective randomized clinical trial, retrospective studies showed that reducing rectal doses by the implantation of PEG hydrogel may result in an improvement in rectal toxicity. CONCLUSIONS: The insertion of hydrogel spacers is safe, resulting in a significant decrease in rectal doses. This may lead to a reduction in rectal or gastrointestinal toxicity. Prospective randomized clinical trials are warranted to confirm the clinical impact of rectal dosimetric improvements.

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Section: Characteristics Of Peg Hydrogelmentioning

confidence: 99%

Section: Characteristics Of Peg Hydrogelmentioning

confidence: 99%

Section: Characteristics Of Peg Hydrogelmentioning

confidence: 99%

Section: Prostateerectum Separationmentioning

confidence: 99%

Section: Prostateerectum Separationmentioning

confidence: 99%

See 3 more Smart Citations

Optimization of prostate brachytherapy techniques with polyethylene glycol–based hydrogel spacers: A systematic review

Ardekani

Ghaffari

2020

Brachytherapy

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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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Biological effective dose in analysis of rectal dose in prostate cancer patients who underwent a combination therapy of VMAT and LDR with hydrogel spacer insertion

Zhang

Wang

Riegel

et al. 2022

J Applied Clin Med Phys

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This study aimed to evaluate rectal dose reduction in prostate cancer patients who underwent a combination of volumetric modulated arc therapy (VMAT) and low-dose-rate (LDR) brachytherapy with insertion of hydrogel spacer (SpaceOAR). For this study, 35 patients receiving hydrogel spacer and 30 patients receiving no spacer were retrospectively enrolled. Patient was treated to doses of 45 Gy to the primary tumor site and nodal regions over 25 fractions using VMAT and 100 Gy to the prostate using prostate seed implant (PSI). In VMAT plans of patients with no spacer, mean doses of rectal wall were 43.6, 42.4, 40.1, and 28.8 Gy to the volume of 0.5, 1, 2, and 5 cm 3 , respectively. In patients with SpaceOAR, average rectal wall doses decreased to 39.0, 36.9, 33.5, and 23.9 Gy to the volume of 0.5, 1, 2, and 5 cm 3 , respectively (p < 0.01). In PSI plans, rectal wall doses were on average 78.5, 60.9, 41.8, and 14.8 Gy to the volume of 0.5, 1, 2, and 5 cm 3 , respectively, in patients without spacer. In contrast, the doses decreased to 34.5, 28.4, 20.6 (p < 0.01), and 8.5 Gy (p < 0.05) to rectal wall volume of 0.5, 1, 2, and 5 cm 3 , respectively, in patient with SpaceOAR. To demonstrate rectal sum dose sparing, dose-biological effective dose (BED) calculation was accomplished in those patients who showed >60% overlap of rectal volumetric doses between VMAT and PSI. In patients with SpaceOAR, average BED sum was decreased up to 34%, which was 90.1, 78.9, 65.9, and 40.8 Gy to rectal volume of 0.5, 1, 2, and 5 cm 3 , respectively, in comparison to 137.4, 116.7, 93.0, and 50.2 Gy to the volume of 0.5, 1, 2, and 5 cm 3 , respectively, in those with no spacer. Our result suggested a significant reduction of rectal doses in those patients who underwent a combination of VMAT and LDR with hydrogel spacer placement.

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Placement of an absorbable rectal hydrogel spacer in patients undergoing low-dose-rate brachytherapy with palladium-103

Cited by 36 publications

References 34 publications

Optimization of prostate brachytherapy techniques with polyethylene glycol–based hydrogel spacers: A systematic review

Optimization of prostate brachytherapy techniques with polyethylene glycol–based hydrogel spacers: A systematic review

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

Biological effective dose in analysis of rectal dose in prostate cancer patients who underwent a combination therapy of VMAT and LDR with hydrogel spacer insertion

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