Hypofractionated intensity modulated irradiation for localized prostate cancer, results from a phase I/II feasibility study.

Background: To assess acute (primary endpoint) and late toxicity, quality of life (QOL), biochemical or clinical failure (secondary endpoints) of a hypofractionated IMRT schedule for prostate cancer (PC).

Methods: 38 men with localized PC received 66 Gy (2.64 Gy) to prostate,2 Gy to seminal vesicles (50 Gy total) using IMRT.Acute toxicity was evaluated weekly during radiotherapy (RT), at 1-3 months afterwards using RTOG acute scoring system. Late side effects were scored at 6, 9, 12, 16, 20, 24 and 36 months after RT using RTOG/EORTC criteria.Quality of life was assessed by EORTC-C30 questionnaire and PR25 prostate module. Biochemical failure was defined using ASTRO consensus and nadir+2 definition, clinical failure as local, regional or distant relapse.

Results: None experienced grade III-IV toxicity. 10% had no acute genito-urinary (GU) toxicity, 63% grade I; 26% grade II. Maximum acute gastrointestinal (GI) scores 0, I, II were 37%, 47% and 16%. Maximal acute toxicity was reached weeks 4-5 and resolved within 4 weeks after RT in 82%.Grade II rectal bleeding needing coagulation had a peak incidence of 18% at 16 months after RT but is 0% at 24-36 months. One developed a urethral stricture at 2 years (grade II late GU toxicity) successfully dilated until now. QOL urinary symptom scores reached a peak incidence 1 month after RT but normalized 6 months later. Bowel symptom scores before, at 1-6 months showed similar values but rose slowly 2-3 years after RT. Nadir of sexual symptom scores was reached 1-6 months after RT but improved 2-3 years later as well as physical, cognitive and role functional scales.Emotional, social functional scales were lowest before RT when diagnosis was given but improved later. Two years after RT global health status normalized.

Conclusion: This hypofractionated IMRT schedule for PC using 25 fractions of 2.64 Gy did not result in severe acute side effects. Until now late urethral, rectal toxicities seemed acceptable as well as failure rates. Detailed analysis of QOL questionnaires resulted in the same conclusion.