Hypofractionated helical intensity-modulated radiotherapy of the prostate bed after prostatectomy with or without the pelvic lymph nodes - the PRIAMOS trial

Sonja Krause,Juergen Debus,Lutz Edler,Florian Sterzing,Klaus Herfarth,Dirk Neuhof

doi:10.1186/1471-2407-12-504

Abstract

BackgroundWhile evidence on safety and efficacy of primary hypofractionated radiotherapy in prostate cancer is accumulating, data on postoperative hypofractionated treatment of the prostate bed and of the pelvic lymph nodes is still scarce. This phase II trial was initiated to investigate safety and feasibility of hypofractionated treatment of the prostate bed alone or with the pelvic lymph nodes.Methods/designA total of 80 prostate cancer patients with the indication for adjuvant radiotherapy will be enrolled, where 40 patients with a low risk of lymph node involvement (arm 1) and another 40 patients with a high risk of lymph node involvement (arm 2) will each receive 54 Gy in 18 fractions to the prostate bed. Arm 2 will be given 45 Gy to the pelvic lymph nodes additionally. Helical Tomotherapy and daily image guidance will be used.DiscussionThis trial was initiated to substantiate data on hypofractionated treatment of the prostate bed and generate first data on adjuvant hypofractionated radiotherapy of the pelvic lymph nodes.Trial registrationClinicalTrials.gov; NCT01620710

Highlights

DiscussionThis trial was initiated to substantiate data on hypofractionated treatment of the prostate bed and generate first data on adjuvant hypofractionated radiotherapy of the pelvic lymph nodes
While evidence on safety and efficacy of primary hypofractionated radiotherapy in prostate cancer is accumulating, data on postoperative hypofractionated treatment of the prostate bed and of the pelvic lymph nodes is still scarce
Helical Tomotherapy (HT) constitutes a fusion of a linear accelerator with a spiral CT scanner, offering the possibility of MV-CT imaging with good soft tissue contrast before each treatment fraction combined with intensity-modulated radiotherapy (IMRT) treatment with sharp dose gradients [18,19]

Summary

Discussion

In definitive radiotherapy for prostate cancer, hypofractionation is being integrated into standard treatment regimen in an increasing amount of treatment centers. An Italian phase I-II trial [24] treated 50 patients with helical IMRT using 58 Gy in 2.8 Gy fractions with excellent safety outcomes that were comparable to their data on conventionally fractionated treatment. Contrary to recent clinical data, the α/β for prostate cancer is as high as 10 Gy, our prescription would result in a BED of 58.5 Gy to the prostate bed and 46.9 Gy to the lymphatic drainage This phase II trial was initiated to substantiate the data on safety and efficacy of postoperative hypofractionated irradiation of the prostate bed, to investigate for the first time hypofractionated treatment of the pelvic lymph nodes and to compare toxicity rates of hypofractionated treatment of the prostate bed alone or with the lymphatic drainage.

Background

Methods/design

Findings