Incidence and follow-up of patients with focal prostate carcinoma in 2 screening rounds after an interval of 4 years

BACKGROUND. Focal carcinoma detected by needle biopsy has been a common finding since prostate-specific antigen (PSA)-based screening was introduced. Clinicopathologic features in patients with focal prostate carcinoma who underwent radical prostatectomy (RP) or who were treated with watchful waiting (WW) were analyzed to detect clinical predictors for disease progression during follow-up. METHODS. Patients were selected from the European Randomized Screening study for Prostate Cancer. Focal carcinoma on sextant biopsy was defined as less than or equal to 3.0 mm involvement by tumor in I biopsy core lacking Gleason pattern 4 or 5. PSA doubling time was used in the WW group as a marker of disease progression. RESULTS. The proportion of patients with focal prostate carcinoma increased significantly from 16% in the first screening round to 29% in the second screening round. One hundred eighteen men underwent RP, and 108 men were treated with WW. The median tumor volume was 0.13 mL. PSA level and prostate volume were predictive for tumor volume in a multivariate regression analysis. A PSA density cut-off level of less than or equal to 0.1 ng/mL/cm(3) predicted organ-confined tumor (< 0.5 mL) in 94% of patients. Positive surgical margins were predictive for PSA recurrence. Four patients in the RP group had PSA recurrence at follow-up. PSA doubling times < 2 years, < 3 years, and < 4 years were noted in 4.9%, 14.6%, and 22.0% of patients in the WW group, respectively. CONCLUSIONS. The median tumor volume was small (0.13 mL). A comparison between PSA recurrence in the RP group and PSA doubling time in the WW group showed a significantly more favorable outcome after RP if a PSA doubling time of < 3 years or < 4 years was chosen as a marker for disease progression in the WW group. A WW policy with delayed curative intent may be recommended in patients ages 55-75 years with focal carcinoma and PSA density < 0.1 ng/mL/cm(3). (C) 2005 American Cancer Society.