Prevalence of Low-Risk Organ-Confined Prostate Cancer
Approximately 50-75% of newly diagnosed prostate cancers are organ-confined, with roughly one-third of these being low-risk disease suitable for active surveillance. 1, 2
Current Epidemiology of Localized Disease
At diagnosis, approximately 75% of patients have cancer localized to the prostate, which is associated with a 5-year survival rate of nearly 100%. 2
Among patients undergoing radical prostatectomy, 51% have pathologically organ-confined disease at final surgical pathology. 3
The proportion of organ-confined disease has increased significantly with PSA screening, though this represents a shift toward earlier-stage diagnosis rather than a change in underlying disease biology. 1
Low-Risk Disease Prevalence
Approximately one-third of patients with localized prostate cancer meet criteria for active surveillance, indicating they have low-risk disease. 2
In the ProtecT trial, which enrolled 1,643 patients with clinically localized prostate cancer, 77% had Gleason score 6 disease and approximately two-thirds had low-risk prostate cancer. 1
Among men meeting low-risk criteria (stage T1c/T2a, PSA ≤10 ng/mL, Gleason score ≤6), 21.8% had Gleason score upgrade and 23.1% had non-organ confined disease on final surgical pathology, indicating that clinical staging underestimates true disease extent in a substantial minority. 4
Very Low-Risk Disease Characteristics
Men meeting very low-risk criteria (stage T1c, PSA density ≤0.15, Gleason score ≤6, ≤2 positive cores, ≤50% cancer per core) have significantly better outcomes, with only 13.1% showing Gleason upgrade and 8.5% having non-organ confined disease at surgery. 4
The relative risk of adverse pathologic findings is approximately 2-fold lower in very low-risk compared to low-risk disease (RR 1.89 for Gleason upgrade, RR 2.06 for non-organ confined cancer). 4
Clinical Implications and Caveats
Important caveat: While clinical criteria identify "insignificant" or low-risk cancers, as many as 8% of cancers meeting Epstein criteria for insignificant disease are not organ-confined on surgical pathology. 1
The discordance between clinical and pathologic staging underscores the importance of careful patient selection for active surveillance and the need for rigorous monitoring protocols. 1
23-42% of all screen-detected cancers in the United States are estimated to be overtreated, highlighting the substantial burden of low-risk disease in the PSA screening era. 1
PSA screening has introduced 6.9 to 12.3 years of lead-time bias, meaning many detected cancers would not have caused clinical problems during a patient's lifetime. 1