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Purpose A preliminary report of patient reported outcomes (PROs) between men receiving high-dose radiation therapy (RT) on RTOG 0126, a phase III dose-escalation trial treated with either 3-dimensional conformal RT (3D-CRT) or intensity modulated RT (IMRT). Methods 3D-CRT patients received 55.8 Gy to the prostate and proximal seminal vesicles (P+PSV) and allowed for an optional field reduction, then 23.4 Gy to prostate only. IMRT patients received 79.2 Gy to the P+PSV. PROs were assessed at 0 (baseline), 3, 6, 12, and 24 months and included bladder and bowel function assessed with the Functional Alterations due to Changes in Elimination (FACE) and erectile function assessed with the International Index of Erectile Function (IIEF). Analyses included those who completed all data at baseline and at least one follow-up and compared to an imputed data set. Results Of 763 patients randomized to the 79.2-Gy arm, 551 and 595 patients who responded to FACE, 505 and 577 who responded to the IIEF were included in the completed and imputed analyses, respectively. There were no significant differences between modalities for any of the FACE or IIEF subscale or total scores at any time point for either the completed or imputed data sets. Conclusions Despite significant reductions in dose and volume to normal structures using IMRT, this robust analysis of 3D-CRT and IMRT showed no difference in PRO bowel, bladder and sexual functions for similar doses delivered to the P+PSV for IMRT compared to 3D-CRT delivered to either the P+PSV or prostate alone.

BACKGROUND The combination of external‐beam radiotherapy and brachytherapy is used commonly to treat men with prostate cancer. In this analysis, the authors examined the rate of biochemical recurrence (BR) and late grade ≥3 genitourinary (GU) and gastrointestinal (GI) toxicity after treatment with external‐beam radiotherapy and brachytherapy in a multiinstitutional, cooperative group setting. METHODS All eligible patients received external‐beam radiotherapy (45 Gray [Gy] in 25 fractions) followed 2 to 6 weeks later by an interstitial implant using iodine‐125 to deliver an additional 108 Gy. BR was defined in 2 ways: according to the American Society for Therapeutic Radiology and Oncology (ASTRO) Consensus Definition (ACD) and according to the Phoenix definition (PD) (prostate‐specific antigen nadir +2 ng/mL). The Radiation Therapy Oncology Group(RTOG)/European Organization for Research and Treatment of Cancer late radiation morbidity scoring system was used to grade all toxicity. RESULTS One hundred thirty‐eight patients were enrolled, and 130 were eligible for the current analysis. The median follow‐up for surviving patients was 49 months (range, 20–60 months). The 48‐month estimate of late grade ≥3 GU/GI toxicity was 15% (95% confidence interval [95% CI], 8–21%), and the 48‐month estimate of BR was 19% (95% CI, 12–26%) and 14% (95% CI, 8–20%) according to the ACD and PD, respectively. CONCLUSIONS The morbidity observed in this multiinstitutional, cooperative group study was slightly higher than that reported in recent RTOG studies using brachytherapy alone or high‐dose external‐beam radiotherapy. The BR rate observed in this report was similar to that observed with high‐dose external‐beam radiotherapy alone in similar patients. Cancer 2007. © 2007 American Cancer Society.

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