Prostate Hypofractionated Radiation Therapy With Injection of Hyaluronic Acid: Acute Toxicities in a Phase 2 Study

Chapet, O.; Decullier, Évelyne; Bin, Sylvie; Faix, A.; Ruffion, A.; Jalade, P.; Fénoglietto, P.; Udrescu, C.; Enachescu, C.; Azria, D.

doi:10.1016/j.ijrobp.2014.11.027

Cited by 30 publications

(20 citation statements)

References 43 publications

(70 reference statements)

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“…In a Hypofractionated Radiotherapy regimen (20 fractions of 3.1 Gy) with injection of HA Chapet et al (38) reported that 19 prostate cancer patients experienced grade 2 toxicities with urinary obstruction and/or frequency. No grade 3 or 4 toxicities occurred.…”

Section: Saline-filled Spacermentioning

confidence: 99%

“…In multi-institutional phase II trials (30,52) for prostate cancer, one patient experienced a device-related event of grade one proctitis and three patients had procedurerelated complications of focal rectal mucosal necrosis from inadvertent injection of hydrogel into the rectal wall; the bladder was pierced leading to hydrogel leakage into the bladder and urinary retention. Chapet et al (38) reported three patients who experienced lower abdomen pain, hematuria and asthenia after the injection of HA, and one patient developed a hematoma between the rectum and the bladder. Wilder et al (28) emphasized that the main risk associated with injection of cross-linked hyaluronan gel was infection, the occurrence of infectious prostatitis caused by puncture is related to whether or not prophylactic antibiotic regimens were administered, and the use of prophylactic antibiotic therapy is estimated to reduce the risk of infection to <5%.…”

Section: Procedure-related Complicationsmentioning

confidence: 99%

“…Wilder et al (28) emphasized that the main risk associated with injection of cross-linked hyaluronan gel was infection, the occurrence of infectious prostatitis caused by puncture is related to whether or not prophylactic antibiotic regimens were administered, and the use of prophylactic antibiotic therapy is estimated to reduce the risk of infection to <5%. To avoid the occurrence of a hematoma, Chapet et al (38) highlighted the importance of screening for the potential risk of clotting disorders. For rectal spacer implantation, acute rectal toxicity including rectal discomfort and bleeding is usual.…”

Section: Procedure-related Complicationsmentioning

confidence: 99%

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The role of radioprotective spacers in clinical practice: a review

Tang

Zhao

et al. 2018

Quant. Imaging Med. Surg.

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The delivery of high dose radiotherapy to tumors is often limited by the proximity of the surrounding radiosensitive normal tissues, even using modern techniques such as intensity modulated radiation therapy (IMRT). Previous studies have reported that placement of a spacer can effectively displace normal tissues. So that they are some distance away from the lesion, thus allowing for the safe delivery of high-dose radiation. The application of radioprotective spacers was first reported 30 years ago regarding radiotherapy of tongue and abdominal cancers; more recently, they are increasingly being used in prostate cancer. This review focuses on the published data concerning the features of different types of spacers and their application in various tumor sites. Placement-related complications and the cost-effectiveness of the spacers are also discussed. With the increasing use of high-precision radiotherapy in clinical practice, especially the paradigm-changing stereotactic body radiotherapy (SBRT), more robust studies are warranted to further establish the role of radioprotective spacers through materials development and novel placement techniques.

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Section: Saline-filled Spacermentioning

confidence: 99%

Section: Procedure-related Complicationsmentioning

confidence: 99%

Section: Procedure-related Complicationsmentioning

confidence: 99%

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The role of radioprotective spacers in clinical practice: a review

Tang

Zhao

et al. 2018

Quant. Imaging Med. Surg.

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“…Spacer studies have been reported after several different treatment concepts, as low-dose rate [24] and highdose rate (HDR) brachytherapy [22,25] with or without additional EBRT, hypofractionated EBRT concepts [26] or proton and heavy ion concepts [27,28] . Rare spacer-related complications have been reported in the literature, as focal rectal necrosis or ulceration as a result of unintentional injection of hydrogel into the rectal wall or urinary retention, usually resolving within a short time [14] .…”

Section: Clinical Experiencementioning

confidence: 99%

“…Prada et al [25] did not observe grade 2 or higher toxicity after HDR brachytherapy as monotherapy (single 19Gy fraction) in an analysis of 40 patients and a median follow-up of 18 mo. Chapet et al [26] reported the acute toxicity of a hypofractionated IMRT with 3.1Gy fractions up to 62Gy total dose in 36 patients, without any grade 2 or higher toxicities. PEG hydrogel stability during treatment has been shown in studies, so that a constant prostate-rectum separation can be expected [32] .…”

Section: Clinical Experiencementioning

confidence: 99%

Current role of spacers for prostate cancer radiotherapy

Pinkawa

2015

WJCO

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Radiotherapy is an established curative treatment method for prostate cancer. Optimal tumor control rates can only be achieved with high local doses, associated with a considerable risk of rectal toxicity. Apart from already widely adapted technical advances, as intensity-modulated radiation therapy, the application of spacers placed between the prostate and rectum has been increasingly used in the last years. Biodegradable spacers, including hydrogel, hyaluronic acid, collagen or an implantable balloon, can be injected or inserted in a short procedure under transrectal ultrasound guidance via a transperineal approach. A distance of about 1.0-1.5 cm is usually achieved between the rectum and prostate, excluding the rectal wall from the high isodoses. Several studies have shown well tolerated injection procedures and treatments. Apart from considerable reduction of rectal irradiation, a prospective randomized trial demonstrated a reduction of rectal toxicity after hydrogel injection in men undergoing prostate image-guided intensity-modulated radiation therapy. The results are encouraging for continuing evaluation in dose escalation, hypofractionation, stereotactic radiotherapy or re-irradiation trials in the future.

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Hyaluronic Acid Spacer for Hypofractionated Prostate Radiation Therapy

et al. 2023

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ImportanceHypofractionated radiation therapy (RT) for prostate cancer has been associated with greater acute grade 2 gastrointestinal (GI) toxic effects compared with conventionally fractionated RT.ObjectiveTo evaluate whether a hyaluronic acid rectal spacer could (1) improve rectal dosimetry and (2) affect acute grade 2 or higher GI toxic effects for hypofractionated RT.Design, Setting, and ParticipantsThis randomized clinical trial was conducted from March 2020 to June 2021 among 12 centers within the US, Australia, and Spain, with a 6-month follow-up. Adult patients with biopsy-proven, T1 to T2 prostate cancer with a Gleason score 7 or less and prostate-specific antigen level of 20 ng/mL or less (to convert to μg/L, multiply by 1) were blinded to the treatment arms. Of the 260 consented patients, 201 patients (77.3%) were randomized (2:1) to the presence or absence of the spacer. Patients were stratified by intended 4-month androgen deprivation therapy use and erectile quality.Main Outcomes and MeasuresFor the primary outcome, we hypothesized that more than 70% of patients in the spacer group would achieve a 25% or greater reduction in the rectal volume receiving 54 Gy (V54). For the secondary outcome, we hypothesized that the spacer group would have noninferior acute (within 3 months) grade 2 or higher GI toxic effects compared with the control group, with a margin of 10%.ResultsOf the 201 randomized patients, 8 (4.0%) were Asian, 26 (12.9%) Black, 42 (20.9%) Hispanic or Latino, and 153 (76.1%) White; the mean (SD) age for the spacer group was 68.6 (7.2) years and 68.4 (7.3) years for the control group. For the primary outcome, 131 of 133 (98.5%; 95% CI, 94.7%-99.8%) patients in the spacer group experienced a 25% or greater reduction in rectum V54, which was greater than the minimally acceptable 70% (P &lt; .001). The mean (SD) reduction was 85.0% (20.9%). For the secondary outcome, 4 of 136 patients (2.9%) in the spacer group and 9 of 65 patients (13.8%) in the control group experienced acute grade 2 or higher GI toxic effects (difference, −10.9%; 95% 1-sided upper confidence limit, −3.5; P = .01).Conclusions and RelevanceThe trial results suggest that rectal spacing with hyaluronic acid improved rectal dosimetry and reduced acute grade 2 or higher GI toxic effects. Rectal spacing should potentially be considered for minimizing the risk of acute grade 2 or higher toxic effects for hypofractionated RT.Trial RegistrationClinicalTrials.gov Identifier: NCT04189913

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Prostate Hypofractionated Radiation Therapy With Injection of Hyaluronic Acid: Acute Toxicities in a Phase 2 Study

Cited by 30 publications

References 43 publications

The role of radioprotective spacers in clinical practice: a review

The role of radioprotective spacers in clinical practice: a review

Current role of spacers for prostate cancer radiotherapy

Hyaluronic Acid Spacer for Hypofractionated Prostate Radiation Therapy

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