[Preliminary data of the Spanish contribution to the European Randomized Study on Screening of Prostate Cancer (ERSPC)]

Abstract

Objectives: Data from the participation of our department in the ERSPC study in terms of detection and PSA diagnostic yield, staging, therapeutic management and mortality in the context of a multicentric randomized screening study for prostate cancer.

Methods: Patients were recruited between February 1996 and June 1999, randomized in screening and control arms, with several rounds for screening patients with four-year intervals, with PSA analysis and sextant prostate biopsy (t PSA > 4 ng/ml before May 1998, tPSA > 2.99 ng/ml after May 1998). These tests were not done in the control group. All deaths were studied (date and cause)

Results: A total of 4278 patients were included, 24 16 in the screening arm (56.4%) and 1862 in the control arm (43.5%), with an age between 45 and 70 years (mean age 57.8 years, 95 CI 57.6-58.0). Median follow-up was 8.77 years. 142 prostate cancers were found, 113 in the screening arm (accumulated detection rate 4.7%) and 29 in the control arm (1.6%). Detection rates were 1.7%, 2.2% and 0% in the first, second and third round respectively. Organ confined cancers (T1 and T2) were 102 in the screening arm (90.3%) and 24 in the control arm (82.8%), p = 0.254 . Metastatic disease was found in six patients (4.2% out of 142), 3 in the screening arm ( 2.7%) and three in the control arm (10.3%), p = 0.187. Radical prostatectomy was the most frequently performed treatment: 47 cases in the screening arm (41.6%), 10 in the control arm (34.5%). 151 patients have died, 82 in the screening arm and 69 in the control arm. Only 3 of this deaths were secondary to prostate cancer, all of them in the screening arm (p = 0.308).

Conclusions: We observed a non significant tendency to lower clinical stages in patients undergoing screening. Radical surgery was the treatment of choice in patients with prostate cancer. Even with the current follow-up in the series (close to 9 years), no differences have been observed in terms of prostate cancer mortality between both study arms.