Missed or delayed prostate cancer diagnosis

The National Cancer Institute says signs of prostate cancer include a weak flow of urine or frequent urination (opens in a new tab), and that they may be caused by prostate cancer or by other conditions.

A blood test for prostate-specific antigen, or PSA, can raise the question. The Institute says there is no single threshold that distinguishes a normal versus an abnormal PSA result (opens in a new tab). In general a level above 4.0 ng/mL is considered abnormal, and benign conditions can raise it. A biopsy is done to diagnose prostate cancer and find out the grade of the cancer (opens in a new tab).

In a statement dated May 8, 2018, the U.S. Preventive Services Task Force says that for men aged 55 to 69 years the decision to undergo periodic PSA-based screening should be an individual one (opens in a new tab). That is its grade C. It recommends against PSA-based screening in men 70 years and older, its grade D. The statement covers men without symptoms, and the Task Force’s site says an update for this topic is in progress (opens in a new tab).

For a man without symptoms, the National Cancer Institute says the doctor may recommend another PSA test in 6 to 8 weeks to confirm the original finding (opens in a new tab).

If the level is still elevated, the doctor may recommend continued observation with repeat PSA tests along with digital rectal exams (opens in a new tab), and if it keeps rising, more tests or a biopsy. Watching the PSA over time is one path the Institute describes.

These are the Institute’s and the Task Force’s documents, and they are not law. What careful practice required for a particular patient is something a qualified physician has to explain.

Research has documented abnormal PSA results that went months without a response. In a study of 327 men diagnosed with prostate cancer from 2000 to 2005 in one health system, 253 (77.4%) had a response to an earlier abnormal PSA value within 30 days (opens in a new tab). For 15.6%, more than 180 days passed before a response. A response could be as little as a note mentioning the result. The abstract reports no stage or survival.

A biopsy samples the gland and can miss cancer. In a 2017 United Kingdom study, the standard ultrasound-guided needle biopsy detected 48% of the clinically significant cancers (opens in a new tab) found in the same men by the study’s reference test, a template mapping biopsy. A cancer diagnosed after a negative biopsy is not, by that fact alone, evidence that the biopsy or its reading was faulty.

In a 2019 study of malpractice claims over diagnostic errors in primary care, missed cancer diagnoses were 980 (46%) of the cases, most commonly lung, colorectal, prostate or breast cancer (opens in a new tab). Those are shares of lawsuits. They say nothing about how often prostate cancer is missed among patients.

The Task Force estimates that screening programs in men aged 55 to 69 years may prevent approximately 1.3 deaths from prostate cancer over approximately 13 years per 1000 men screened (opens in a new tab), a benefit it calls small. Among the harms it lists is overdiagnosis, which the National Cancer Institute describes as detecting tumors that would not have caused problems during someone’s lifetime (opens in a new tab).

A United Kingdom trial followed 1,643 men whose cancer was confined to the prostate and found by PSA testing. After 15 years of follow-up, death from prostate cancer had occurred in 45 men (2.7%) (opens in a new tab), with no significant difference between active monitoring, surgery and radiotherapy.

The same trial found more spread with monitoring: metastases developed in 9.4% of the men assigned to active monitoring (opens in a new tab), against 4.7% and 5.0% in the other two groups. Active monitoring is organized testing, a different thing from a cancer nobody has found. The trial says nothing about men whose cancer had already spread when diagnosed.

These figures describe groups of men. None says what a delay meant for one man. In Illinois a patient has to prove that the care was negligent and that the negligence more probably than not caused the harm, which can be a lost chance of a better outcome. That takes expert proof in each case.

A review starts with the PSA results over time: each value, its date and what was done about it. Then come the biopsy slides and the pathology report with the diagnosis and grade.

Federal rules require a laboratory to keep pathology reports and tissue slides for at least 10 years (opens in a new tab), and specimen blocks and other test reports, such as a PSA value, for at least 2 years. A hospital licensed under the Illinois Hospital Licensing Act must preserve its medical records for not less than 10 years (opens in a new tab). That Act does not cover hospitals run by the federal government or by a state university (opens in a new tab).

Illinois law requires a health care facility to let a patient examine the records of their care and have copies made (opens in a new tab). It helps to write down the dates of your tests and visits, and what you were told.