Explore the vast range of titles available.

IntroductionRadiation dose to the rectum in prostate brachytherapy (PBT) can be reduced by the use of polyethylene glycol (PEG) hydrogel spacers. This reduces the rate of rectal toxicity and allows dose escalation to the prostate. Our objectives were to provide an overview of technique for injection of a PEG hydrogel spacer, reduction in rectal dosimetry, gastrointestinal toxicity and potential complications.MethodsWe systematically reviewed the role of PEG hydrogel spacers in PBT using the Cochrane and PRISMA methodology for all English-language articles from January 2013 to December 2019. Data was extracted for type of radiotherapy, number of patients, type of PEG-hydrogel used, mean prostate-rectum separation, rectal dosimetry, acute and late GI toxicity, procedure-related complications and the technique used for hydrogel insertion.ResultsNine studies (671 patients and 537 controls) met our inclusion criteria. Of these 4 used DuraSeal® and 5 used SpaceOAR®. The rectal spacing achieved varied between 7.7-16 mm. Failure of hydrogel insertion was seen only in 12 patients, mostly related to failure of hydrodissection in patients undergoing salvage PBT. Where reported, the rectal D2 cc was reduced by between 21.6 and 52.6% and the median rectal V75% cc was reduced by between 91.8–100%. Acute GI complications were mostly limited to grade 1 or 2 toxicity (n = 153, 33.7%) with low levels of grade 3 or 4 toxicity (n = 1, 0.22%). Procedure-related complications were limited to tenesmus (0.14%), rectal discomfort (1.19%), and bacterial prostatitis (0.44%).ConclusionsPEG hydrogel spacers are safe to insert. Gel insertion is easy, fast and has a low rate of failure. These studies convincingly demonstrate a significant reduction in rectal dosimetry. Although the results of spacers in reducing rectal toxicity is promising, these need to be confirmed in prospective randomised trial.

The study aimed to assess the effect of a rectal spacer on the inter-fraction motion of the seminal vesicles (SV) during prostate stereotactic body radiotherapy (SBRT). Clinical data from 60 consecutive patients (300 fractions) with localized prostate cancer treated with definitive SBRT alone (five fractions), between June 2022 and January 2024 were retrospectively reviewed. Of the 60 patients, 44 had a spacer implanted. The residual displacement of SVs in the cone-beam CT relative to those in the planning CT was compared between with and without spacer. The maximum displacement of the proximal SV in 90% of the patients was also evaluated. Additionally, the relationship between the gel/prostate volume ratio and SV displacement was analyzed. The gel/prostate volume ratio was 30 ± 15%. Proximal SV displacement significantly differed with and without the spacer (2.0 vs. 3.8 mm, P  < 0.001). Maximum proximal SV displacement also significantly differed with and without the spacer (3.0 vs. 5.1 mm, P  < 0.001). In 90% of patients with the spacer, the maximum proximal SV displacement was within 4 mm. SV displacement did not change according to gel/prostate volume ratio. The spacer can limit inter-fraction motion of SVs. The gel/prostate volume ratio was not clinically significant.

Background and purpose This prospective study aimed to investigate adaptive magnetic resonance (MR)-guided stereotactic body radiation therapy (MRgSBRT) with rectal spacer for localized prostate cancer (PC) and report 1-year clinical outcomes. Materials and methods Thirty-four consecutive patients with low- to high-risk localized PC that underwent 5-fraction adaptive MRgSBRT with rectal spacer were enrolled. The dosimetric comparison was performed on a risk- and age-matched cohort treated with MRgSBRT but without a spacer at a similar timepoint. Clinician-reported outcomes were based on Common Terminology Criteria for Adverse Events. Patient-reported outcomes were based on the Expanded Prostate Cancer Index Composite (EPIC) questionnaire at baseline, acute (1–3 months), subacute (4–12 months), and late (> 12 months) phases. Results The median follow-up was 390 days (range 28–823) and the median age was 70 years (range 58–82). One patient experienced rectal bleeding soon after spacer insertion that subsided before MRgSBRT. The median distance between the midline of the prostate midgland and the rectum after spacer insertion measured 7.8 mm (range 2.6–15.3), and the median length of the spacer was 45.9 mm (range 16.8–62.9) based on T2-weighted MR imaging. The use of spacer resulted in significant improvements in target coverage (V100% > 95% = 98.6% [range 93.4–99.8] for spacer vs. 97.8% [range 69.6–99.7] for non-spacer) and rectal sparing (V95% < 3 cc = 0.7 cc [range 0–4.6] for spacer vs. 4.9 cc [range 0–12.5] for non-spacer). Nine patients (26.5%) experienced grade 1 gastrointestinal toxicities, and no grade ≥ 2 toxicities were observed. During the 1-year follow-up period, EPIC scores for the bowel domain remained stable and were the highest among all other domains. Conclusions MRgSBRT with rectal spacer for localized PC showed exceptional tolerability with minimal gastrointestinal toxicities and satisfactory patient-reported outcomes. Improvements in dosimetry, rectal sparing, and target coverage were achieved with a rectal spacer. Randomized trials are warranted for further validation.

Background/Objectives: Stereotactic radiotherapy (SABR) is a recognized standard treatment modality for localized prostate cancer, though data is limited regarding the risk of increased toxicity when including the elective nodes (ENI) for high-risk disease. Placement of a peri-rectal spacer can decrease the risk of toxicity to the rectum when administering high-dose prostate radiotherapy. Herein we present toxicity findings for patients who underwent five-fraction prostate SABR with ENI in a setting with peri-rectal spacing. Methods: Genitourinary (GU) and gastrointestinal (GI) toxicity data was analyzed for patients with ≥12 months of follow-up who were treated with curative-intent five-fraction SABR with ENI. A radiopaque hydrogel spacer was placed for all eligible patients. The primary endpoints were the three-month toxicity, which was measured using CTCAEv5, and quality of life (QoL), which was measured using EPIC 26. Secondary endpoints included intermediate-term GU and GI toxicity between 6 and 12 months. Univariable logistic regression was used to assess associations between baseline patient characteristics and the presence of a peri-rectal hydrogel spacer and GU and GI toxicity. Results: Among the 100 patients treated, 69 had grade group 4/5 disease and 40 had evidence of T3a/3b extension. The ENI dose was 25 Gy/5, and 78.9% of the patients received 40 Gy to the prostate, while the remainder were given 36.25–37.5 Gy. A total of 70% underwent placement of a radiopaque hydrogel spacer. GU toxicities of grades 1, 2, and 3 were reported in 28/22/1% of the patients, respectively, at three months; in 18/11/0% at six months; in 11/9/0% at nine months; and in 5/3/0% at twelve months. GI toxicities of grades 1 and 2 were reported in 14/0% of the patients at three months and 8/1% at six months, with all cases resolving by nine months. MCICs in the urinary incontinence, urinary obstructive, and bowel domains were reported in 5%, 18%, and 4% at three months; by twelve months, these values decreased to 2%, 2%, and 0%, respectively. The presence of a hydrogel spacer resulted in reductions in high and intermediate doses to the rectum and had a significant inverse association with short-term GI toxicity (HR: 0.09, CI: 0.27–0.35, p: 0.0004). Conclusions: In this prospective series, five-fraction SABR including ENI was well tolerated, and the presence of a hydrogel spacer was associated with a lower risk of rectal toxicity.

To report on rectal dosimetry and toxicity outcomes in men with prostate cancer (PCa) treated with iodine-125 low-dose-rate brachytherapy (LDR-BT) with or without polyethylene glycol hydrogel (HS) or hyaluronic acid (HA) rectal spacer (RS) insertion. Seventy consecutive men treated with LDR-BT between December 2017 and July 2019 were included in this study, including twenty-eight (40%) men who had RS insertion according to the preference of referring urologist, compared to a group of forty-two men (60%) without RS. Descriptive statistics were used to compare RS safety, dosimetric effects on organs at risk (rectum and urethra), and gastrointestinal (GI) and genitourinary toxicities (GU) (assessed using the CTCAE v.4) between the two groups of patients. The median prostate-rectal separation with RS at mid prostate was 10 mm (IQR, 8-11.5 mm). The median follow-up was 23.5 months. There were no post-operative complications for RS insertion. There was significantly reduced rectal dosimetry in RS-group vs. non-RS group; the median RV was 0.0 cc (IQR, 0.0-0.0 cc) vs. 0.4 cc (IQR, 0.1-1.1 cc) ( < 0.001), respectively. The mean rectal D and D were 52.4% vs. 84.2% ( < 0.001) and 45.7% vs. 70.0% ( < 0.001) for RS and non-RS group, respectively. There were no statistically significant differences in the mean urethral D , D , and D . There were significantly less grade 1 acute and late GI toxicities in RS-group when compared to non-RS group (0% vs. 24%, = 0.004 for acute GI toxicity; 4% vs. 33%, = 0.003 for late GI toxicity). There were no reported acute or late grade 2 or above GI toxicities. Insertion of RS in men treated with LDR-BT is safe and resulted in a significant reduction in rectal dosimetry. The reduction in rectal dosimetry with RS insertion translates into significantly reduced acute and late GI toxicities.

Although the dosimetric advantages of rectal spacers in prostate cancer radiotherapy have been demonstrated in selected clinical trials, real-world data from routine clinical practice remain limited—particularly within the Portuguese healthcare system. This study offers a detailed dosimetric comparison of Volumetric Modulated Arc Therapy (VMAT), with and without rectal spacer use, in a real-world patient cohort, aiming to assess the clinical relevance of spacer insertion under standard treatment protocols. A retrospective dosimetric evaluation was performed on 80 prostate cancer patients treated at a radiotherapy centre in southern Portugal. Patients were equally divided into two matched groups (n = 40): one receiving VMAT alone, the other receiving VMAT with hydrogel rectal spacer placement. Dose-volume histograms (DVHs) were analysed for the planning target volume (PTV) and key organs at risk (OARs). Standard dosimetric metrics, such as V50–V75 for the rectum and bladder, V50 for femoral heads, and mean dose for the penile bulb, were assessed. PTV coverage was evaluated using conformity and homogeneity indices. Spacer use significantly decreased rectal dose exposure across all evaluated parameters without compromising PTV coverage or increasing dose to other OARs. These findings support routine rectal spacer applications to enhance treatment safety and patient outcomes.

Background: Pelvic reirradiation of de novo rectal or anal cancer after prior prostate cancer RT poses a significant risk of urinary and rectal fistula. In this report we describe the use of a rectal spacer to improve dosimetry and reduce this risk. Methods: Patients undergoing anorectal radiotherapy (RT) after prior prostate RT who had a rectal spacer placed prior to RT were identified in a prospective database. Patient, disease, and treatment characteristics were collected for these patients. Survival data were calculated from the end of RT. Radiation was delivered with intensity-modulated radiation therapy (IMRT) or proton beam therapy (PBT) following rectal spacer placement. Results: Rectal spacer placement with hydrogel injected transperineally under transrectal ultrasound guidance was successful in all five patients. MR/CT simulation 1–2 weeks post-spacer placement and IMRT or PBT delivered to a dose of 36–50 Gy in 24–30 fractions once or twice daily were tolerated well by all patients. The V100% of the PTV ranged from 62–100% and mean rectal and bladder dose ranged from 39–46 Gy and 16–40 Gy, respectively. At the last follow-up, three patients were alive and without evidence of disease up to 48 months out from treatment. There were no acute or late grade 3 or higher toxicities observed, but acute grade 2 proctitis was observed in all patients. Conclusions: The use of a rectal spacer placement to improve dosimetry of IMRT and PBT after prior prostate RT is safe and feasible in appropriately selected anorectal cancer patients.

Prostate cancer is a significant health concern for men, emphasizing the need for effective treatment strategies. Dose-escalated external beam radiotherapy shows promise in improving outcomes but presents challenges due to radiation effects on nearby structures, such as the rectum. Innovative techniques, including rectal spacers, have emerged to mitigate these effects. This study comprehensively assessed tissue responses following the implantation of the Bioprotect biodegradable fillable balloon as a rectal spacer in a rat model. Evaluation occurred at multiple time points (4, 26, and 52 weeks) post-implantation. Results revealed localized tissue responses consistent with the expected reaction to biodegradable materials, characterized by mild to moderate fibrotic reactions and encapsulation, underscoring the safety and biocompatibility of the balloon. Importantly, no other adverse events occurred, and the animals remained healthy throughout the study. These findings support its potential clinical utility in radiotherapy treatments to enhance patient outcomes and minimize long-term implant-related complications, serving as a benchmark for future similar studies and offering valuable insights for researchers in the field. In conclusion, the findings from this study highlight the safety, biocompatibility, and potential clinical applicability of the Bioprotect biodegradable fillable balloon as a promising rectal spacer in mitigating radiation-induced complications during prostate cancer radiotherapy.

Prostate cancer is the most common cancer in men. External beam radiotherapy by a variety of methods is a standard treatment option with excellent disease control. However, acute and late rectal side effects remain a limiting concern in intensification of therapy in higher-risk patients and in efforts to reduce treatment burden in others. A number of techniques have emerged that allow for high-radiation dose delivery to the prostate with reduced risk of rectal toxicity, including image-guided intensity-modulated radiation therapy, endorectal balloons and various forms of rectal spacers. Image-guided radiation therapy, either intensity-modulated radiation therapy or stereotactic ablative radiation therapy, in conjunction with a rectal spacer, is an efficacious means to reduce acute and long-term rectal toxicity.

Background:Prostate cancer is a common malignancy with rising incidence in Western countries such as the United Kingdom. In localised disease there are a variety of curative treatment modalities. Patients can be referred for surgery, or for a combination of hormonal therapies and radiotherapy (external beam radiotherapy or brachytherapy). Each treatment option comes with side effects and in the case of radiotherapy one potential complication is bowel toxicity from radiation exposure. New technologies are being developed to try and mitigate the side effects and long term morbidity of this treatment, and to expand access to radiotherapy for patients who may previously have been excluded (i.e those with inflammatory bowel disease). Rectal Spacers are absorbable polyethylene glycol hydrogels injected into the perirectal space. These position the anterior rectal wall away from the prostate, subsequently minimising radiation dose to the rectum. Rectal Spacers have been introduced to National Healthcare Service (NHS) practice as part of the Innovation and Technology Payment (ITP) programme, however, their use is now under review.Methodology and Results:In this editorial we conduct a narrative review of some of the available evidence for Rectal Spacers, discuss their utilization within the NHS and the barriers to their wider use. We also explore preliminary dosimetry and quality of life data for use of Rectal Spacers in our centre where we have been part of the NHS ITP programme. Dosimetry data and Quality of life questionnaires were gathered from 22 treated patients and 11 matched controls. This indicated lower radiation doses to the prostate in those treated with Rectal Spacers.Conclusion:Rectal Spacers are an effective method to reduce radiation dose to the prostate in men treated for localised prostate cancer, however, their use remains under review in the NHS and there are a variety of barriers to upscaling their use.