Prospective, Randomized Controlled Pivotal Trial of Biodegradable Balloon Rectal Spacer for Prostate Radiation Therapy
Rectal spacers have been shown to reduce rectal side effects in patients receiving prostate radiation. However, concerns remain regarding precise and reproducible gel injection. We evaluated efficacy and safety of a novel rectoprostatic spacer balloon that allows potential for controlled, adaptable...
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| Vydané v: | International journal of radiation oncology, biology, physics Ročník 120; číslo 5; s. 1410 |
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| Hlavní autori: | , , , , , , , , , , , , , , , |
| Médium: | Journal Article |
| Jazyk: | English |
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United States
01.12.2024
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| ISSN: | 1879-355X, 1879-355X |
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| Abstract | Rectal spacers have been shown to reduce rectal side effects in patients receiving prostate radiation. However, concerns remain regarding precise and reproducible gel injection. We evaluated efficacy and safety of a novel rectoprostatic spacer balloon that allows potential for controlled, adaptable deployment. This study tested co-primary hypotheses: (1) balloon spacer would result in ≥25% reduction of rectal V70 in >75% of subjects and (2) implantation procedure-related and rectal ≥grade 1 adverse events within 6 months (duration ≥2 days, Common Terminology Criteria for Adverse Events 4.0) would be noninferior in balloon versus control subjects.
A total of 222 subjects were enrolled at 16 centers. All patients had T1-T3 prostate cancer without magnetic resonance imaging evidence of posterior extraprostatic invasion. Randomization was 2:1 (balloon: control) and subject-blinded. Patients underwent transperineal transrectal ultrasound axial and sagittal-guided fiducial placement ± balloon, followed by Intensity-Modulated Radiation Therapy (81 Gy in 1.8 Gy fractions or biologically equivalent hypofractionated dose). For efficacy comparisons, plans were generated by a central core lab on pre- and postimplant computed tomography scans.
The primary efficacy endpoint was met, with 97.9% of balloon subjects (139/142) having rectal V70 reduction >25% (P < .001). Mean V70 was 7.0 % pre- versus 1.1% postimplant. The primary safety endpoint was met with balloon subjects experiencing fewer ≥grade 1 events, 18% versus 23% (P < .001 for noninferiority). On predefined secondary endpoint of ≥grade 2 events, rates trended lower in balloon subjects (4.3% vs 6.5%, P = .527). Mean perirectal spacing was 19 ± 3.7 mm and maintained through radiation treatment (18 ± 3.9 mm). Balloon resorption was observed on 6-month computed tomography in 98.5% (133/135) of subjects. The Expanded Prostate Cancer Index quality of life instrument was collected throughout study, and did not differ statistically between the study arms.
Biodegradable rectal spacer balloon was effective in significantly reducing dose to rectum, and associated with decreased cumulative rectal plus implantation-related adverse events. Balloon resorption was consistently observed by 6 months. |
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| AbstractList | Rectal spacers have been shown to reduce rectal side effects in patients receiving prostate radiation. However, concerns remain regarding precise and reproducible gel injection. We evaluated efficacy and safety of a novel rectoprostatic spacer balloon that allows potential for controlled, adaptable deployment. This study tested co-primary hypotheses: (1) balloon spacer would result in ≥25% reduction of rectal V70 in >75% of subjects and (2) implantation procedure-related and rectal ≥grade 1 adverse events within 6 months (duration ≥2 days, Common Terminology Criteria for Adverse Events 4.0) would be noninferior in balloon versus control subjects.PURPOSE/OBJECTIVESRectal spacers have been shown to reduce rectal side effects in patients receiving prostate radiation. However, concerns remain regarding precise and reproducible gel injection. We evaluated efficacy and safety of a novel rectoprostatic spacer balloon that allows potential for controlled, adaptable deployment. This study tested co-primary hypotheses: (1) balloon spacer would result in ≥25% reduction of rectal V70 in >75% of subjects and (2) implantation procedure-related and rectal ≥grade 1 adverse events within 6 months (duration ≥2 days, Common Terminology Criteria for Adverse Events 4.0) would be noninferior in balloon versus control subjects.A total of 222 subjects were enrolled at 16 centers. All patients had T1-T3 prostate cancer without magnetic resonance imaging evidence of posterior extraprostatic invasion. Randomization was 2:1 (balloon: control) and subject-blinded. Patients underwent transperineal transrectal ultrasound axial and sagittal-guided fiducial placement ± balloon, followed by Intensity-Modulated Radiation Therapy (81 Gy in 1.8 Gy fractions or biologically equivalent hypofractionated dose). For efficacy comparisons, plans were generated by a central core lab on pre- and postimplant computed tomography scans.METHODS AND MATERIALSA total of 222 subjects were enrolled at 16 centers. All patients had T1-T3 prostate cancer without magnetic resonance imaging evidence of posterior extraprostatic invasion. Randomization was 2:1 (balloon: control) and subject-blinded. Patients underwent transperineal transrectal ultrasound axial and sagittal-guided fiducial placement ± balloon, followed by Intensity-Modulated Radiation Therapy (81 Gy in 1.8 Gy fractions or biologically equivalent hypofractionated dose). For efficacy comparisons, plans were generated by a central core lab on pre- and postimplant computed tomography scans.The primary efficacy endpoint was met, with 97.9% of balloon subjects (139/142) having rectal V70 reduction >25% (P < .001). Mean V70 was 7.0 % pre- versus 1.1% postimplant. The primary safety endpoint was met with balloon subjects experiencing fewer ≥grade 1 events, 18% versus 23% (P < .001 for noninferiority). On predefined secondary endpoint of ≥grade 2 events, rates trended lower in balloon subjects (4.3% vs 6.5%, P = .527). Mean perirectal spacing was 19 ± 3.7 mm and maintained through radiation treatment (18 ± 3.9 mm). Balloon resorption was observed on 6-month computed tomography in 98.5% (133/135) of subjects. The Expanded Prostate Cancer Index quality of life instrument was collected throughout study, and did not differ statistically between the study arms.RESULTSThe primary efficacy endpoint was met, with 97.9% of balloon subjects (139/142) having rectal V70 reduction >25% (P < .001). Mean V70 was 7.0 % pre- versus 1.1% postimplant. The primary safety endpoint was met with balloon subjects experiencing fewer ≥grade 1 events, 18% versus 23% (P < .001 for noninferiority). On predefined secondary endpoint of ≥grade 2 events, rates trended lower in balloon subjects (4.3% vs 6.5%, P = .527). Mean perirectal spacing was 19 ± 3.7 mm and maintained through radiation treatment (18 ± 3.9 mm). Balloon resorption was observed on 6-month computed tomography in 98.5% (133/135) of subjects. The Expanded Prostate Cancer Index quality of life instrument was collected throughout study, and did not differ statistically between the study arms.Biodegradable rectal spacer balloon was effective in significantly reducing dose to rectum, and associated with decreased cumulative rectal plus implantation-related adverse events. Balloon resorption was consistently observed by 6 months.CONCLUSIONSBiodegradable rectal spacer balloon was effective in significantly reducing dose to rectum, and associated with decreased cumulative rectal plus implantation-related adverse events. Balloon resorption was consistently observed by 6 months. Rectal spacers have been shown to reduce rectal side effects in patients receiving prostate radiation. However, concerns remain regarding precise and reproducible gel injection. We evaluated efficacy and safety of a novel rectoprostatic spacer balloon that allows potential for controlled, adaptable deployment. This study tested co-primary hypotheses: (1) balloon spacer would result in ≥25% reduction of rectal V70 in >75% of subjects and (2) implantation procedure-related and rectal ≥grade 1 adverse events within 6 months (duration ≥2 days, Common Terminology Criteria for Adverse Events 4.0) would be noninferior in balloon versus control subjects. A total of 222 subjects were enrolled at 16 centers. All patients had T1-T3 prostate cancer without magnetic resonance imaging evidence of posterior extraprostatic invasion. Randomization was 2:1 (balloon: control) and subject-blinded. Patients underwent transperineal transrectal ultrasound axial and sagittal-guided fiducial placement ± balloon, followed by Intensity-Modulated Radiation Therapy (81 Gy in 1.8 Gy fractions or biologically equivalent hypofractionated dose). For efficacy comparisons, plans were generated by a central core lab on pre- and postimplant computed tomography scans. The primary efficacy endpoint was met, with 97.9% of balloon subjects (139/142) having rectal V70 reduction >25% (P < .001). Mean V70 was 7.0 % pre- versus 1.1% postimplant. The primary safety endpoint was met with balloon subjects experiencing fewer ≥grade 1 events, 18% versus 23% (P < .001 for noninferiority). On predefined secondary endpoint of ≥grade 2 events, rates trended lower in balloon subjects (4.3% vs 6.5%, P = .527). Mean perirectal spacing was 19 ± 3.7 mm and maintained through radiation treatment (18 ± 3.9 mm). Balloon resorption was observed on 6-month computed tomography in 98.5% (133/135) of subjects. The Expanded Prostate Cancer Index quality of life instrument was collected throughout study, and did not differ statistically between the study arms. Biodegradable rectal spacer balloon was effective in significantly reducing dose to rectum, and associated with decreased cumulative rectal plus implantation-related adverse events. Balloon resorption was consistently observed by 6 months. |
| Author | Song, Daniel Dabkowski, Mateusz Costa, Paulo Nurani, Rizwan Soffen, Edward Hudes, Richard Boychak, Oleksandr Kos, Michael Sapir, Eli Tokita, Kenneth Wang, Dian Vanneste, Ben Zimberg, Shawn Alhasso, Abdulla Magel, David Symon, Zvi |
| Author_xml | – sequence: 1 givenname: Daniel surname: Song fullname: Song, Daniel email: kerma99@gmail.com organization: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland. Electronic address: kerma99@gmail.com – sequence: 2 givenname: Mateusz surname: Dabkowski fullname: Dabkowski, Mateusz organization: Department of Brachytherapy, Oncology Center Institute of Maria Skłodowska Curie (MCMCC), Warsaw, Poland – sequence: 3 givenname: Paulo surname: Costa fullname: Costa, Paulo organization: CUF Porto Instituto Rua Fonte das Sete Bicas, Senhora da Hora Matosinhos, Portugal – sequence: 4 givenname: Rizwan surname: Nurani fullname: Nurani, Rizwan organization: Western Radiation Oncology (WRO), B Campbell, California – sequence: 5 givenname: Michael surname: Kos fullname: Kos, Michael organization: Northern Nevada Radiation Oncology, Reno, Nevada – sequence: 6 givenname: Ben surname: Vanneste fullname: Vanneste, Ben organization: MAASTRO Clinic Dr. Tanslaan, Maastricht, The Netherlands – sequence: 7 givenname: David surname: Magel fullname: Magel, David organization: Rabin Medical Center, Petah Tikva, Israel – sequence: 8 givenname: Eli surname: Sapir fullname: Sapir, Eli organization: Ha-Refu'a St 7 Ashdod, Assuta, Israel – sequence: 9 givenname: Shawn surname: Zimberg fullname: Zimberg, Shawn organization: Advanced Radiation Centers of New York, Lake Success, New York – sequence: 10 givenname: Oleksandr surname: Boychak fullname: Boychak, Oleksandr organization: St Luke's Hospital, Rathgar, Dublin, Ireland – sequence: 11 givenname: Edward surname: Soffen fullname: Soffen, Edward organization: Astera Cancer Care, Monroe Township, New Jersey – sequence: 12 givenname: Abdulla surname: Alhasso fullname: Alhasso, Abdulla organization: Beatson West of Scotland Cancer Centre, Glasgow, Scotland – sequence: 13 givenname: Kenneth surname: Tokita fullname: Tokita, Kenneth organization: KSK Medical Center, Irvine, California – sequence: 14 givenname: Dian surname: Wang fullname: Wang, Dian organization: Rush University Medical Center, Chicago, Illinois – sequence: 15 givenname: Zvi surname: Symon fullname: Symon, Zvi organization: Shiba Medical Center, Tel Hashomer, Israel – sequence: 16 givenname: Richard surname: Hudes fullname: Hudes, Richard organization: Chesapeake Urology Research, Owings Mills, Maryland |
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| Snippet | Rectal spacers have been shown to reduce rectal side effects in patients receiving prostate radiation. However, concerns remain regarding precise and... |
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| SubjectTerms | Absorbable Implants Aged Aged, 80 and over Fiducial Markers Humans Male Middle Aged Prospective Studies Prostatic Neoplasms - diagnostic imaging Prostatic Neoplasms - pathology Prostatic Neoplasms - radiotherapy Radiation Injuries - prevention & control Radiotherapy, Intensity-Modulated - adverse effects Radiotherapy, Intensity-Modulated - methods Rectum - diagnostic imaging Rectum - radiation effects |
| Title | Prospective, Randomized Controlled Pivotal Trial of Biodegradable Balloon Rectal Spacer for Prostate Radiation Therapy |
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