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 < or = 6, a serum prostate-specific antigen (PSA) level of < or = 15 ng/mL, stage < or = 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 < or = 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.