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This is where the number 4.0 came from. Screening 1,653 healthy men over 50 with a blood test and biopsying those above that level found cancers that a finger examination would have missed, and the threshold entered practice worldwide.
William Catalona and colleagues measured serum prostate-specific antigen in 1,653 healthy men aged 50 or over, sent those at or above 4.0 micrograms per litre for rectal examination and ultrasonography, and biopsied those with abnormal findings. They compared the results against 300 men biopsied because of symptoms or an abnormal examination.
The paper is short, clear and enormously consequential. It established the 4.0 threshold, showed that the blood test detected cancers that digital rectal examination alone would have missed, and concluded that the combination of the antigen and examination detected prostate cancer better than examination alone. Within a decade prostate-specific antigen testing had spread through United States primary care without a randomised trial of whether it saved lives, which is why the two trials that followed, ERSPC and PLCO, matter so much and why they disagreed so badly.
The paper that made opportunistic prostate-specific antigen testing routine, and the source of the threshold still printed on laboratory reports. Everything in the overdiagnosis literature is, in effect, an audit of what this recommendation did when it was applied to whole populations.
The D'Amico system, refined by the NCCN, remains the framework for the very-low to very-high-risk categories used on this site's prostate pages.
The origin of the blood test that defines how prostate cancer is found, monitored and declared to have recurred. Its strength was always monitoring a known cancer; the problems began when the same test was used to look for cancer in men who had no symptoms.
Shares PLCO: mortality results from a randomised prostate cancer screening trial, Lead time, and lead-time bias, ERSPC: screening and prostate cancer mortality in a randomised European study, PSA (prostate-specific antigen) and the tag prostate-evidence.
Shares Lead time, and lead-time bias, Number needed to screen (and number needed to diagnose), ERSPC: screening and prostate cancer mortality in a randomised European study, PSA (prostate-specific antigen) and the tag prostate-evidence.
Shares Lead time, and lead-time bias, Number needed to screen (and number needed to diagnose), ERSPC: screening and prostate cancer mortality in a randomised European study, Early detection roadmap: organ screening → blood tests for many cancers and the tag prostate-evidence.
Shares Prostate-specific antigen as a serum marker for adenocarcinoma of the prostate, Lead time, and lead-time bias, PSA (prostate-specific antigen), Localised prostate cancer, very low and low risk and the tag prostate-evidence.
Shares Number needed to screen (and number needed to diagnose), PSA (prostate-specific antigen), Localised prostate cancer, intermediate risk, Localised prostate cancer, very low and low risk and the tag prostate-evidence.
Shares Lead time, and lead-time bias, PSA (prostate-specific antigen), Localised prostate cancer, very low and low risk, Screening and the tag prostate-evidence.
Shares PSA (prostate-specific antigen), Localised prostate cancer, intermediate risk, Localised prostate cancer, very low and low risk, Screening and the tag prostate-evidence.
Shares D'Amico risk groups: biochemical outcome after radical prostatectomy, external beam radiotherapy or brachytherapy, Localised prostate cancer, intermediate risk, Overdiagnosis and false alarms, 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.