Focus is on narrowly defined criteria and a standard regimen of PSA tests, DRE, and repeat biopsy
Active surveillance (AS) is a reasonable alternative to immediate intervention in appropriately selected patients with low-risk prostate cancer.
Their findings are based on a study of 99 men with localized prostate cancer who met certain criteria, which included a Gleason score of 6 or less; a serum PSA level of 15 ng/mL or less, stage T2 disease or less; low-volume disease, and more than 12 months of follow-up.
The investigators, led by Mark S. Soloway, MD, of the University of Miami Miller School of Medicine, conducted rigorous follow-up, including PSA tests and digital rectal examinations (DREs) every three months for two years, and a repeat prostate biopsy six to 12 months after the initial diagnosis and then every year as indicated. Dr. Soloway’s group continued AS based on PSA doubling time, re-biopsy score, Gleason score, tumor volume, stage progression, and patient preference.
The patients had a mean age of 66 years and a mean PSA level of 5.77 ng/mL, the authors reported in BJU International (2007; published online ahead of print). The mean follow-up on AS was 45.3 months (range 12-178 months).
On initial repeat biopsy, 63% had no cancer and 34% had a Gleason sum of 6 or less. Eight patients were treated, including two who underwent radical prostatectomy, three who had radiotherapy, and three who had hormone therapy. According to the investigators, the study population had an 85% probability of remaining treatment-free at five years. No patient died from prostate cancer. PSA doubling time and clinical stage at diagnosis predicted progression. Seven patients were lost to follow-up.
The investigators observed that although the use of AS as a management strategy is controversial, their study demonstrates that men with low-risk prostate cancer who are monitored closely with PSA tests and repeat biopsies “might have a reasonable alternative to immediate intervention, without compromising curability. It is imperative that there are narrowly defined inclusion criteria and a standard regimen of PSA tests, DRE and repeat biopsy.”
In discussing study limitations, the researchers noted that “because of the size of the treatment group and relatively short follow-up for three of the eight treated patients, it is difficult to make absolute assumptions about the efficacy of AS or to draw conclusions about disease-free survival.”