Multicenter, randomized, phase III trial comparing radical retropubic prostatectomy with conventional external beam radiotherapy for localized prostate cancer: An interim report

Background: We report the outcomes of a randomised trial comparing radical retropubic prostatectomy (RP) with conventional external beam radiotherapy (EBRT) in patients with clinically localized prostate cancer. Methods: Between January 1997 and September 2001, 137 patients with clinically localized diagnosed prostate cancer were randomly assigned to RP (n = 70) or EBRT (n = 67). Data collected at follow-up included evidence of clinical disease progression, survival rates and general and disease specific health-related quality of life. All data were measured by physical examination, digital rectal examination, PSA, annual TC and bone scan and questionnaire. Analysis was by intention to treat. Results: After a median follow-up of 67 months (range 24–88) 35 patients (32.8%) had evidence of biochemical disease progression, 22 (31.4%) in RP group and 23 (32.8%) in EBRT group respectively. The median time to biochemical failure was 55.5 months (range 1–86) in RP group and 56 (range 3–88) in EBRT group. A local progression was observed in 11 patients (15.79%) of RP group and 12 (17.9%) of EBRT group. The median time to local progression was 65 months (range 6–86) in RP group and 64 (range 6–88) in EBRT group. Distant metastases were observed in 4 patients (5.7%) in RP group and 6 (8.9%) in EBRT group. The median time to distant failure was 67 months (range 12–86) in RP group and 66 (range 12–88) in EBRT group. Death due to prostate cancer occurred in 3/70 of patients assigned to RP (4.3%) and in 1/67 of those assigned to EBRT (1.5%). A significant decrease in general HRQOL was evident only in the first month after RP (p < 0.001). At 2 years, patients undergoing RP report significantly worse urinary function (p < 0.001), but better bowel function than those treated with EBRT (p < 0.001). Sexual dysfunction was more prevalent in the RP than in the EBRT group (70.2% versus 61.2%). Conclusions: This interim analysis indicates that there was no significant difference between RP and EBRT in terms of clinical disease progression and survival rates in patients with clinically localized prostate cancer. However, additional larger sample size accrual and long-term follow-up data are warranted to confirm these results.