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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
hypofractionated helical IMRT of the prostate bed, 18 x 3 Gy
helical IMRT of the prostate bed (18 x 3 Gy) and the pelvic lymph nodes (18 x 2.5 Gy)
Dep. of Radiation Oncology, University Hospital of Heidelberg
Heidelberg, Germany
proportion SDR of patients with no grade III/IV toxicity and/or treatment discontinuation
Proportion SDR of patients with no NCI CTC AE grade 3-4 toxicity and no discontinuation of treatment during the full set of 18 fractions by any reasons in the intent-to-treat (ITT) population
Time frame: 2 years
biochemical recurrence free survival (BFS)
Time frame: 2 years
Quality of Life
Quality of Life Scores as measured by the EORTC-QLQ30 and -PR25 questionnaires
Time frame: 2 years
overall survival
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.