Active surveillance; a reasonable management alternative for patients with prostate cancer: the Miami experience

OBJECTIVE To examine the outcome of patients diagnosed with ‘low‐risk’ prostate cancer managed by active surveillance (AS). PATIENTS AND METHODS In all, 157 men with localized prostate cancer were followed on AS. The inclusion criteria for AS included: Gleason score of ≤ 6, a serum prostate‐specific antigen (PSA) level of ≤15 ng/mL, stage ≤ T2, low‐volume disease and >12 months of follow‐up. The follow‐up was rigorous, with PSA tests and a digital rectal examination every 3 months for 2 years, and a repeat biopsy 6–12 months after the initial diagnosis and yearly when indicated. Continuance of AS was based on the PSA doubling time, re‐biopsy score, Gleason score, tumour volume, stage progression and patient preference. RESULTS In all 99 patients met the inclusion criteria; their mean age at diagnosis was 66 years, their mean PSA level 5.77 ng/mL and the mean follow‐up 45.3 months. On initial repeat biopsy, 63% had no cancer and 34% had a Gleason sum of ≤ 6. Eight patients were treated (three with hormones; five with curative intent); two had radical prostatectomy (one had pT2c pNO Gleason 7 disease); three had radiotherapy. The probability is that 85% would remain treatment‐free at 5 years; no patient died from prostate cancer. The PSA doubling time and clinical stage at diagnosis were predictive of progression. CONCLUSION Patients who are followed on AS must be selected using narrowly defined inclusion criteria and closely followed with a standard regimen of PSA testing, digital rectal examination and repeat biopsy.