Patients with very low risk disease were offered AS since 1995, and a total of 769 were considered. Men meeting the low-risk criteria at diagnostic biopsy underwent PSA monitoring, DRE and annual 12-14 core surveillance biopsy at regular intervals. Definitive intervention was offered for an upgrade in Gleason score >6, more than 2 cores with CaP, or >50% involvement of any core with cancer. PSA kinetics were not used as a trigger for intervention.
Among the 769 men enrolled in the AS program, 17.7% did not meet the PSA density criteria and 3.9% did not meet one of the other criteria. However, no patients with a Gleason score ≥7 on the diagnostic biopsy were enrolled. By 2010, 418 men (54.4%) were still active in the AS program without curative intervention or exiting, 255 (33.2%) underwent curative intervention, 82 (10.7%) withdrew or were lost to follow-up, and 14 (1.8%) died from causes other than CaP. A total of 235 men (30.6%) demonstrated biopsy reclassification; Gleason score upgrading occurred in 106 (45.1%), 129 (54.9%) had increased number or percentage of core involvement. Thirty-eight of 129 men reclassified by increased disease volume elected to defer treatment and continue on AS. The compliance with the first and second biopsies was 92% and 91%. The median time on AS free of curative intervention was 6.5 years, and the probability of a patient remaining on AS at 2, 5, and 10 years was 81%, 59%, and 41%, respectively. Sixty-seven men (26.3%) elected curative intervention in the absence of biopsy reclassification, and 188 men (73.7%) on the basis of biopsy reclassification. A total of 192 men underwent curative treatment, and of those 96 elected radical prostatectomy, and 96 elected radiotherapy. The median time to treatment was 2-2.3 years. A total of 18 of 192 men (9.4%) had biochemical recurrence; 4 of those men underwent surgery and 14 underwent radiotherapy.
By this report date no patient in the cohort had developed metastatic disease or died from prostate cancer.
Tosoian JJ, Trock BJ, Landis P, Feng Z, Epstein JI, Partin AW, Walsh PC, Carter HB
J Clin Oncol. 2011 Jun 1;29(16):2185-90
10.1200/JCO.2010.32.8112
PubMed Abstract
PMID: 21464416
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