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1/2025
vol. 29
abstract:
Original paper
Perirectal spacers in radiotherapy for prostate cancer – a systematic review and meta-analysis
Constantinos Zamboglou
5, 6
,
Ichiro Tsuboi
1, 10, 11
,
Shahrokh F. Shariat
1, 8, 18, 19, 20, 21, 22, 23
- Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria
- Collegium Medicum Faculty of Medicine, WSB University, Dąbrowa Górnicza, Poland
- Department of Radiotherapy, Holy Cross Cancer Center, Kielce, Poland
- Radiation Oncology Unit, Oncology Department, Azienda Ospedaliero Universitaria Careggi, Firenze, Italy
- Department of Radiation Oncology, Medical Center – Faculty of Medicine, University of Freiburg, Germany
- German Oncology Center, Europen University Cyprus, Limassol, Cyprus
- Department of Experimental and Clinical Medicine, University of Florence, Unit of Oncologic Minimally-Invasive Urology and Andrology, Careggi Hospital, Florence, Italy
- Department of Urology, Semmelweis University, Budapest, Hungary
- Department of Urology, Jikei University School of Medicine, Tokyo, Japan
- Department of Urology, Shimane University Faculty of Medicine, Shimane, Japan
- Department of Urology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan
- Department of Urology, Jagiellonian University Medical College, Kraków, Poland
- Department of Urology, Yale University School of Medicine, New Haven, CT, USA
- Division of Surgery and Interventional Sciences, University College London, London, UK
- Second Department of Urology, Centre of Postgraduate Medical Education, Warszawa, Poland
- Department of Radiotherapy, ICO René Gauducheau, Saint-Herblain, France
- Nantes University, Nantes, France
- Karl Landsteiner Institute of Urology and Andrology, Vienna, Austria
- Department of Urology, Second Faculty of Medicine, Charles University, Prague, Czech Republic
- Division of Urology, Department of Special Surgery, University of Jordan, Amman, Jordan
- Department of Urology, Weill Cornell Medical College, New York, NY, USA
- Department of Urology, University of Texas Southwestern, Dallas, TX, USA
- Research Centre for Evidence Medicine, Urology Department, Tabriz University of Medical Sciences, Tabriz, Iran
Contemp Oncol (Pozn) 2025; 29 (1): 36–44
Online publish date: 2025/03/13
PlumX metrics:
Introduction:
Perirectal spacers reduce the radiotherapy (RT) dose delivered to the rectum, but their impact on treatment toxicity remains debated. We conducted a systematic review and meta-analysis to synthesise emerging data (PROSPERO: CRD42024506380).
Material and methods:
MEDLINE, Embase, Scopus, and Google Scholar were searched through 2024/08/18 for prospective randomised (RCT) and non-randomised trials evaluating the clinical outcomes of perirectal spacing in prostate cancer (PCa) patients. Random effects generalised linear mixed models were used to pool odds ratios (OR) for rectal adverse events (AEs) from RCTs. Non-randomised trials were summarised qualitatively. The risk of bias was assessed using the RoB2 and ROBINS-I tools.
Results:
Three RCTs (n = 645) were identified. The rates of grade ≥ 2 (G ≥ 2) rectal AEs in control groups were low, ranging 4.2–13.8% for early AEs and 0–1.4% for late AEs. Perirectal spacers were associated with decreased incidence of early G ≥ 2 rectal AEs (OR: 0.43; 95% CI: 0.19–0.96), but not of late G ≥ 2 rectal AEs (OR: 0.26; 95% CI: 0.02–2.91). Assuming a comparator risk of 7.1% and 1%, this corresponded to a number needed to treat of 26 patients to avoid one early AE, and 135 patients to avoid one late G ≥ 2 AE, respectively. Randomised clinical trial were at moderate risk of bias due to concerns regarding the concealment of allocation.
Conclusions:
There is evidence that perirectal spacers result in a small decrease in acute rectal toxicity. However, modern RT for clinically localised PCa is generally well-tolerated, and severe AEs are rare. Greater scrutiny of the risks and benefits associated with perirectal spacers is necessary.
keywords:
SpaceOAR, Barrigel, ProSpace, gastrointestinal toxicity, acute toxicity, chronic toxicity
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