Acute toxicity and quality of life in high risk prostate cancer patients: Updated results of randomized hypofractionation trial.

Purpose: The aim of our study was to perform the final analysis of acute toxicity and quality of life data obtained from 221 consecutive patients who suffered from intermediate-to-high risk prostate cancer.

Methods: In this trial, 221 patients were randomized to receive either hypofractionated (63 Gy in 20 fractions, 4 fractions/week) or conventionally fractionated (76 Gy in 38 fractions, 5 fractions/week) radiotherapy to the prostate and seminal vesicles. Elective pelvic lymph node irradiation with 46 Gy in 23 fractions sequentially and 44 Gy in 20 fractions simultaneously was also applied.

Results: There was no statistically significant difference in acute GU and GI toxicity in men treated with hypofractionated (SIB) (Arm 2) in comparison with patients who had conventional fractionation (Arm 1) radiation therapy. Multivariate analysis using logistic regression showed statistical significant association between acute GU ≥ 1 and PTV(LN) ( p  = 0.008) only. We found out that clinically relevant decrease (CRD) was significantly higher only in the urinary domain of Arm 1 at month 3 ( p  = 0.02).

Conclusion: Our study demonstrated that hypofractionated radiotherapy was associated with a small but insignificant increase of acute toxicity. The reduction of overall treatment time has no significant influence on patients' QOL in any domain.