Prospective validation of stringent dose constraints for prostatic stereotactic radiation monotherapy: results of a single-arm phase II toxicity-oriented trial.

PURPOSE: There are no safety-focused trials on stereotactic body radiotherapy (SBRT) for localized prostate cancer. This prospective 3­year phase II trial used binomial law to validate the safety and efficacy of SBRT with stringent organ at risk dose constraints that nevertheless permitted high planning target volume doses. METHODS: All consecutive ≥ 70-year-old patients with localized prostate adenocarcinoma who underwent SBRT between 2014 and 2018 at the National Radiotherapy Center in Luxembourg were included. Patients with low Cancer of Prostate Risk Assessment (CAPRA) scores (0-2) and intermediate scores (3-5) received 36.25 Gy. High-risk (6-10) patients received 37.5 Gy. Radiation was delivered in 5 fractions over 9 days with Cyberknife-M6™ (Accuray, Sunnyvale, CA, USA). Primary study outcome was Common Terminology Criteria for Adverse Events version 4 (CTCAEv4) genitourinary and rectal toxicity scores at last follow-up. Based on binomial law, SRBT was considered safe in this cohort of 110 patients if there were ≤ 2 severe toxicity (CTCAEv4 grade ≥ 3) cases. Secondary outcomes were biochemical progression-free survival (bPFS) and patient quality of life (QOL), as determined by the IPPS and the Urinary Incontinence QOL questionnaire. RESULTS: The first 110 patients who were accrued in a total cohort of 150 patients were included in this study and had a median follow-up of 36 months. Acute grade ≥ 3 toxicity never occurred. One transient late grade 3 case was observed. Thus, our SBRT program had an estimated severe toxicity rate of < 5% and was safe at the p < 0.05 level. Overall bPFS was 90%. QOL did not change relative to baseline. CONCLUSION: The trial validated our SBRT regimen since it was both safe and effective.

[Radiotherapy at the Grand Duchy of Luxembourg]. / L'oncologie radiothérapique au Grand-Duché de Luxembourg. Trois premières années de fonctionnement du Centre François Baclesse.

The Centre François Baclesse was created as National Radiotherapy Center in 2000. Oncology Radiotherapy has been developed in Luxembourg in parallel with existing medical and surgical oncology departments. Cancer is a Public Health problem in Luxembourg. More than 1800 new cases of cancer are diagnosed every year, out of wich 70 % will need radiotherapy at the time of the evolution of the disease. Technical platform and Human Resources available at this time are able to deliver high quality treatment. The activity reached a plateau in 2002 with almost 800 patients treated per year, whereas the theorical need for radiation oncology treatment is 1200 patients per year in Luxembourg. A large architectural project will add 2 new linear accelerators and will be finished by 2007-2008. Multidisciplinary oncological network has been developed together with cancer treatment units of 6 luxembourgish hospitals. Clinical Research is one of the missions of the Center. After the achievement of its extension, the Centre François Baclesse will be able to cover the need of the Regional, luxembourgish and cross-boarder patients pool, in line with an European approach in treating cancer.

[Evaluation of results of radiotherapy and localized prostate cancer, Experiences at the Francois Baclesse Center 2000-2001]. / Evaluation des résultats de la radiothérapie dans les cancers localisés de la prostate. Expérience du Centre François Baclesse 2000-2001.

UNLABELLED: The authors report the collegial activity performed during the first two years of François Baclesse Center existence. This experience results from the collaboration between Luxemburgish Urologists and technical and medical staff of the National Radiotherapy Center. 194 new prostate cancer cases have been recorded between 2000 and 2001. 98 of them have been treated by curative three-dimensional conformal radiotherapy. For the 72 Gy level of dose, ilio-obturator curage has been performed in 50% of the patients. 82% of the patients have been treated by concomitant hormotherapy. For the 74 Gy level of dose, 50% of the patients have an ilio-obturator curage and 84% received concomitant hormotherapy. Radiotherapy post-prostatectomy has been done for 7 patients. The subject of the discussion is the respect of Standardized Good Practices as defined in Luxemburg. CONCLUSION: The national strategy instaured since September 2000 has been respected. The Urologists are invited to transmit post-radiotherapy toxicities to the clinical research associate. EORTC 22991 protocol is now initiated. The aim of this study is to demonstrate that combining three-dimensional conformal radiotherapy and adjuvant hormonotherapy can increase survival and reduce metastatic progression risk in localized prostate cancer (T1, T2).