Late toxicity was defined as rectal or urinary symptoms occurring or persisting 6 months or more after completing radiotherapy. The secondary endpoints were biochemical failure, biopsy result and clinical failure. The freedom from biochemical failure (FFBF) was defined as the time interval find more from the first day of radiotherapy to the biochemical relapse, the scores are according to the most recent Phoenix definition of nadir PSA +2 ng/ml . The histological
diagnosis of the prostate biopsy at 2-years post-radiotherapy was classified as positive (prostatic adenocarcinoma without typical radiation-induced changes), negative (no evidence of carcinoma) or indeterminate (severe treatment effects). Baseline and follow-up All patients were prostate adenocarcinoma pre-treatment biopsy proven. Baseline staging was assessed
by initial PSA (iPSA) levels, digital rectal examination (DRE), transrectal ultrasound images, abdomino-pelvic CT, chest RX/CT and bone scan. At baseline, patients were asked to answer questions about their urinary symptoms according to the International Prostate Symptoms Score (IPSS) questionnaire . Patients were monitored weekly during the course of radiotherapy, after 2 and 6 months from the end of the treatment, and then every six months until the second year of follow-up. Afterwards patients were monitored annually. PSA evaluation and DRE were performed at each follow-up visit and a report was drafted, with special emphasis on treatment-related morbidity, GDC-0449 solubility dmso which recorded the worst toxicity score for each patient. In case of an increased PSA and/or suspected clinical local relapse (new or increasing palpable prostate nodule) or distant failure (bone pain, low extremity edema, unjustified dyspnea, etc.), the usual diagnostic VX-689 supplier imaging procedures or prostate biopsies nearly were carried out. All patients underwent a sextant prostate re-biopsy after at least 2 years after the radiation treatment. Statistical analysis For all measured
endpoints, patients were censored at the time of the specific event. Actuarial curves of the length of time until late toxicity or biochemical failure were calculated by the Kaplan-Meier product-limit method. All times were calculated from the first day of radiotherapy. Differences between dosimetric parameters between groups were evaluated by a Mann–Whitney test. Results Patients and dosimetry From January 2005 to April 2010 39 patients with histologically proven adenocarcinoma of the prostate were enrolled in an IMRT dose escalation protocol with a total dose of 86 Gy in 43 fractions. The rate of accrual was limited by the inclusion criteria of freedom from ADT. The median follow-up for the cohort was 71 months (range 32.8-93.6 months) and the median age was 71.5 years (range 52.5-77.4 yrs). On average, 99.9% (standard deviation 0.1%) of the PTV volume received at least 77.5 Gy (V100), and 95% of the PTV volume (D95) received an average dose of 82.7 Gy (standard deviation: 1.0 Gy).