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Hypofractionated Helical Intensity-Modulated Radiotherapy of the Prostate Bed After Prostatectomy With or Without the Pelvic Lymph Nodes - the PRIAMOS Trial
This trial investigates safety and feasibility of a hypofractionated radiotherapy (i.e. with higher daily doses and shorter total treatment time compared to standard fractionation) of the prostate bed with or without 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. 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. 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 wil be used.
Age
18 - 80 years
Sex
MALE
Healthy Volunteers
No
Dep. of Radiation Oncology, University Hospital of Heidelberg
Heidelberg, Germany
Start Date
February 1, 2012
Primary Completion Date
September 1, 2015
Completion Date
September 30, 2017
Last Updated
October 16, 2018
80
ACTUAL participants
hypofractionated helical IMRT
RADIATION
hypofractionated helical IMRT
RADIATION
Lead Sponsor
Heidelberg University
NCT05691465
NCT04550494
Data Source & Attribution
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