Phase II Trial of Hypofractionated Image-Guided Intensity-Modulated Radiotherapy for Localized Prostate Adenocarcinoma

Male Salvage Therapy Conformal radiotherapy Image guidance Biopsy Prostate Prostatic Neoplasms Adenocarcinoma Prostate-Specific Antigen ResearchInstitutes_Networks_Beacons/mcrc; name=Manchester Cancer Research Centre 3. Good health Prostate carcinoma 03 medical and health sciences 0302 clinical medicine Treatment toxicity Hypofractionation Feasibility Studies Humans Dose Fractionation, Radiation Prospective Studies Radiotherapy, Intensity-Modulated Aged
DOI: 10.1016/j.ijrobp.2007.04.049 Publication Date: 2007-07-03T07:21:07Z
ABSTRACT
To assess in a prospective trial the feasibility and late toxicity of hypofractionated radiotherapy (RT) for prostate cancer.Eligible patients had clinical stage T1c-2cNXM0 disease. They received 60 Gy in 20 fractions over 4 weeks with intensity-modulated radiotherapy including daily on-line image guidance with intraprostatic fiducial markers.Between June 2001 and March 2004, 92 patients were treated with hypofractionated RT. The cohort had a median prostate-specific antigen value of 7.06 ng/mL. The majority had Gleason grade 5-6 (38%) or 7 (59%) disease, and 82 patients had T1c-T2a clinical staging. Overall, 29 patients had low-risk, 56 intermediate-risk, and 7 high-risk disease. Severe acute toxicity (Grade 3-4) was rare, occurring in only 1 patient. Median follow-up was 38 months. According to the Phoenix definition for biochemical failure, the rate of biochemical control at 14 months was 97%. According to the previous American Society for Therapeutic Radiology and Oncology definition, biochemical control at 3 years was 76%. The incidence of late toxicity was low, with no severe (Grade > or =3) toxicity at the most recent assessment.Hypofractionated RT using 60 Gy in 20 fractions over 4 weeks with image guidance is feasible and is associated with low rates of late bladder and rectal toxicity. At early follow-up, biochemical outcome is comparable to that reported for conventionally fractionated controls. The findings are being tested in an ongoing, multicenter, Phase III trial.
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