Affiliation:
1. Clinique Pasteur
2. Clinique pont de chaume
3. Clinique la croix du sud
4. Clinique des Cèdres
5. clinique d'occitane
Abstract
Abstract
Background
Due to the close proximity of the prostate and rectum, rectal toxicity remains a major problem in patient treated by radiotherapy for prostate adenocarcinoma. One method of increasing the distance between the prostate and the rectum is to use a spacer implanted into the rectoprostatic space. This report describes the long-term outcomes obtained with a new ballon spacer.
Methods
Patients treated with curative radiotherapy for low- or intermediate-risk prostate adenocarcinoma, who underwent insertion of the ProSpace® (BioProtect Ltd, Tzur Yigal, Israel) rectal-prostate balloon spacer, were included. The main objective was to evaluate the dosimetric benefit of the spacer for OARs. The secondary objectives were to evaluate the feasibility and tolerability of ProSpace® balloon placement and to evaluate its long-term therapeutic efficacy and tolerance.
Results
Between October 2013 and March 2015, 16 patients were enrolled in the Pasteur Clinic, Toulouse, France. The median follow-up was 85.5 months. From top to bottom, the space created was a mean of 16.3 mm (range: 11–20.5 mm) at the base of the prostate, 12.1 mm (range: 4–16 mm) at the middle and 8.9 mm at the apex (range: 5–15 mm). On average, rectal volumes receiving a dose of 70 Gy, 60 Gy and 50 Gy were significantly lower after balloon implantation: -4.81 cc (1.5 vs. 6.3; p<0.0005), -8.08cc (6.4 vs. 14.5; p=0.002) and -9.06cc (16.7 vs. 25.7; p=0.003), respectively. There were significant differences in coverage after balloon implantation: Mean V95% (p<0.0005), mean Dmin (p=0.01) and mean V98% (p<0.001) were higher after balloon implantation. At 5 years, cumulative gastrointestinal toxicity was grade 1 in 6% (1/16 patients). No toxicity of grade 2 or higher was found. At 5 years, no urinary toxicity grade 3 or 4 toxicity was found. The QoL was not deteriorated.
Conclusions
The use of the ProSpace® balloon seems to be well accepted by patients, allowing a double dosimetric gain: a decrease in doses received by the rectum and an improvement in the coverage of the high-risk PTV. The long-term gastrointestinal toxicity remains low and QoL is preserved in all treated patients.
Publisher
Research Square Platform LLC
Reference37 articles.
1. External radiotherapy for prostatic cancers;Crevoisier R;Cancer/Radiothérapie févr,2022
2. Urofrance | Recommandations françaises. du Comité de cancérologie de l’AFU – actualisation 2020–2022: cancer de la prostate - Urofrance [Internet]. [cité 18 mai 2022]. Disponible sur: https://www.urofrance.org/recommandation/recommandations-francaises-du-comite-de-cancerologie-de-lafu-actualisation-2020-2022-cancer-de-la-prostate/.
3. The use of clinical parameters in an interactive statistical package to predict pathological features associated with local failure after radical prostatectomy for prostate cancer;D’Amico A;Clin Perform Qual Health Care déc,1993
4. 10-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Localized Prostate Cancer;Hamdy FC;N Engl J Med
5. Prostate cancer radiation dose response: results of the M. D. Anderson phase III randomized trial;Pollack A;Int J Radiat Oncol Biol Phys 1 août,2002