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Open Access Study protocol

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

Sonja Krause1*, Florian Sterzing1, Dirk Neuhof1, Lutz Edler2, Juergen Debus1 and Klaus Herfarth2

Author affiliations

1 Department of Radiation Oncology, University Hospital Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany

2 Department of Biostatistics, German Cancer Research Center, Im Neuenheimer Feld 280, 69120, Heidelberg, Germany

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Citation and License

BMC Cancer 2012, 12:504  doi:10.1186/1471-2407-12-504

Published: 31 October 2012

Abstract

Background

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. 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/design

A 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.

Discussion

This 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 registration

ClinicalTrials.gov; NCT01620710

Keywords:
Prostate cancer; Radiotherapy; Hypofractionation; Helical tomotherapy; Prostate bed; Pelvic lymph nodes