Abstract
BackgroundFor patients with treatment-naïve carcinoma of the prostate, hypofractionated irradiation becomes more and more popular. Due to the low α/β value of prostate cancer, increased single dose leading to a shortened treatment period seems to be safe and feasible. However, reliable data is lacking for post-prostatectomy patients so far. Further, the role of proton therapy is still under debate. Two prospective phase II trials with both, hypofractionated photon and proton therapy, provided promising results.Methods/ designThe PAROS trial is a prospective, multicenter and randomized phase III trial for men with localized prostate carcinoma after surgery. Post-prostatectomy patients will be randomized to either normofractionated radiotherapy (nRT) with photons (70.0/ 2.0 Gy), or hypofractionated radiotherapy (hRT) with photons (57.0/ 3.0 Gy) or hRT with protons (57.0/ 3.0 Gy relative biological effectiveness [RBE]). Block randomization is stratified by Gleason Score (≤ 7 vs. > 7) and treatment indication (adjuvant vs. salvage). The trial is planned to enroll 897 patients. The primary objective is to show an improvement in the bowel-score according to EORTC QLQ-PR25 after proton therapy compared to photon irradiation (week 12 vs. baseline). Secondary aims are non-inferiority of hRT compared to nRT with regard to biochemical progression-free survival (bPFS), overall survival (OS), quality of life and toxicity.DiscussionThe present study aims to evaluate the role of hypofractionated radiotherapy to the prostate bed with photons and protons leading to significant impact on future management of operated men with prostate cancer.Trial registrationDeutsches Register klinischer Studien: DRKS00015231; registered 27 September 2018.
Highlights
For patients with treatment-naïve carcinoma of the prostate, hypofractionated irradiation becomes more and more popular
The present study aims to evaluate the role of hypofractionated radiotherapy to the prostate bed with photons and protons leading to significant impact on future management of operated men with prostate cancer
After prostatectomy, irradiation is recommended for several patients with prostate cancer due to various criteria like positive resection margins or prostate specific antigen (PSA) relapse
Summary
Irradiation is recommended for several patients with prostate cancer due to various criteria like positive resection margins or PSA relapse. Inconsistent data exist so far with regard to chronic side effects: While several studies reported on similar late toxicity when using postoperative, hRT [12, 20], Cozzarini et al observed a higher risk of late urinary toxicity in a relatively small group of patients who underwent hypofractionation. In this retrospective analysis, the 5year risk of severe (grade ≥ 3) late urinary side effects increased in the heterogeneous cohort of patients treated with different hRT regimes compared to men treated with normofractionation [21].
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