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In men whose prostate cancer was mostly found by a blood test, surgery did not significantly reduce deaths after nearly twenty years. It did cause more incontinence and sexual problems, and it did reduce later treatment for the cancer growing.
Timothy Wilt and the PIVOT investigators randomised 731 men with localised prostate cancer to radical prostatectomy or observation between November 1994 and January 2002 in the United States Department of Veterans Affairs system, and extended follow-up to August 2014, a median of 12.7 years.
PIVOT is the counterweight to SPCG-4 and it enrolled in the prostate-specific antigen era. Neither all-cause nor prostate-cancer mortality reached significance, both at P equals 0.06, and the subgroup analysis suggested benefit in intermediate-risk disease and none in low-risk disease. The harms are unambiguous: urinary incontinence and erectile and sexual dysfunction were greater with surgery through 10 years. Most of the progression that surgery prevented was asymptomatic, local or biochemical.
The trial that made observation a defensible choice for low-risk prostate cancer found by a blood test, and that supplied the number a man needs when weighing surgery: the progression it prevents is mostly progression on a scan or a blood test, and the harms it causes are felt every day.
The clearest evidence that radical treatment of localised prostate cancer saves lives when the cancer was found clinically rather than by a blood test, and the clearest single statement of what grade does: a Gleason score above 7 carried ten times the risk of death of a score of 6 or lower in the same trial.
Most men with low- and favourable intermediate-risk prostate cancer can safely choose monitoring, and treatment choice should weigh urinary, sexual and bowel side effects against a small difference in progression.
Active surveillance is the preferred management for low-risk prostate cancer, and this cohort's triggers for intervention shaped surveillance protocols worldwide.
Shares ProtecT: fifteen-year outcomes after monitoring, surgery or radiotherapy for prostate cancer, Other-cause mortality, Overtreatment, Overdiagnosis and the tag prostate-evidence.
Shares Long-term follow-up of a large active surveillance cohort of patients with prostate cancer (Sunnybrook), Overtreatment, Overdiagnosis, PSA (prostate-specific antigen) and the tag prostate-evidence.
Shares Long-term follow-up of a large active surveillance cohort of patients with prostate cancer (Sunnybrook), Overtreatment, Overdiagnosis, PSA (prostate-specific antigen) and the tag prostate-evidence.
Shares Radical prostatectomy, PSA (prostate-specific antigen), Localised prostate cancer, intermediate risk, Localised prostate cancer, very low and low risk and the tag prostate-evidence.
Shares Overtreatment, Overdiagnosis, PSA (prostate-specific antigen), Localised prostate cancer, very low and low risk and the tag prostate-evidence.
Shares Overtreatment, Overdiagnosis, PSA (prostate-specific antigen), Localised prostate cancer, very low and low risk and the tag prostate-evidence.
Shares Long-term follow-up of a large active surveillance cohort of patients with prostate cancer (Sunnybrook), Radical prostatectomy, Localised prostate cancer, intermediate risk, Localised prostate cancer, very low and low risk and the tag prostate-evidence.
Shares Other-cause mortality, Quality of life, PSA (prostate-specific antigen), Prostate cancer roadmap: from Huggins and the discovery that a cancer can depend on a hormone, through the PSA epidemic and what it cost, the androgen receptor drugs, the DNA repair subset and PSMA, to a 2032 registry watch and the tag prostate-evidence.