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Top Line: If you ever feel like you need a comprehensive source to fall back on when counseling a man on management options for early-stage prostate cancer, the ProtecT trial is here for you.
The Study: Remember, the ProtecT trial randomized men with localized, PSA-detected prostate cancer to active monitoring (AM), radical prostatectomy (RP), or radiation therapy (RT). They were fairly young (50-69 years) mainly white guys, and two-thirds had low-risk disease. In fact, <10% of patients had a PSA over 10 or grade group 3 or higher disease. The original publication reported the intention-to-treat analysis, but there were some big problems there considering a large proportion of men either declined randomization altogether (37% of those eligible) or chose a different management than the one they were assigned (22% of those randomized). This report gives us long-term outcomes based on the actual treatment received for both the randomized and observed cohorts. Half the men who declined randomization chose AM, and they plus those assigned to AM were able to stay on AM for a median of ~7.5 years. By 10 years, the cumulative risk of moving from AM to treatment was 45%, or about 5% per year. With AM, many men were able to avoid the side effects of treatment for many years with a small but significant increase in the risk of metastasis and potentially higher (but still minuscule) chance of dying from prostate cancer. With RP or RT, there was no difference in prostate cancer outcomes. By choosing surgery, there was a much higher risk of long-term incontinence (30-40%) and impotence (85-90%). By choosing RT, there was a higher short-term risk of nocturia (65%) and higher long-term risks of bloody stools (5%) and impotence (60-70%) that eventually converged with AM by year 6.
TBL: Active monitoring in men with (mostly) low risk prostate cancer can defer treatment for going on a decade at the cost of a slightly higher risk of cancer metastases. | Neal, Euro Urol 2019