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Summary of the Recommendations

I. SCREENING
II. DIAGNOSIS / INVESTIGATION
III. MONITORING

I. SCREENING

Using the PSA test for early detection of prostate cancer in asymptomatic men

PSA determination should not be used as a population-wide mass screening test for the early detection of prostate cancer in asymptomatic males.

A brochure has been developed on the potential benefits and risks of the use of a PSA determination for the early detection of prostate cancer for the public. (Contact your local unit of the Canadian Cancer Society to obtain copies of this brochure). The information should assist men between the ages of 50 to 75 who have a life expectancy of greater than 10 years in making an informed decision as to whether to have this test performed. Men who are 40 years of age or older with a family history of prostate cancer (as defined as one or two "first degree" relatives such as father, son, or brother and men of African ancestry) should also receive this information. An information package also been developed for physicians to facilitate counselling for the public on the appropriate use of the PSA test.

Screening Recommendations

PSA determination should not be used as a population-wide mass screening test for the early detection of prostate cancer in asymptomatic males.

When the PSA is below the laboratory's diagnostic cutoff (e.g. 4.0 µg/L or an age-adjusted value), and the DRE is negative, no further action is usually taken, other than possible periodic repeat testing (e.g. every two years).

Screening Recommendations chart

* DRE (Digital rectal examination)
Mildly suspicious: Slight asymmetry, minimal change in texture
Moderately suspicious: Marked asymmetry, obvious induration, nodularity
Highly suspicious: Hard mass

** PSA (Prostate specific antigen)
Normal : Result within the normal range for method
Abnormal: Result outside the normal range for method

The Free to Total PSA test has no value as a first level screen but should be considered to investigate results that are in the 4.0 - 10.0 µg/L range. This improves the diagnostic specificity of total PSA, allowing about 20% of men to avoid having a biopsy.

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II. DIAGNOSIS / INVESTIGATION

Using the PSA test in combination with Digital Rectal Examination (DRE) in patients in whom prostate cancer is suspected

A PSA determination is recommended for any man, with a life expectancy of ten years or more, found to have : a prostatic nodule on DRE, an abnormal-feeling prostate, focal lesion, discrete change either in texture, fullness or symmetry which provokes increased suspicion of prostate cancer, and when investigating a secondary carcinoma of unknown origin.

The use of a PSA test is also recommended for men with moderate or severe symptoms of prostatism in whom treatment is contemplated. Severe and moderate symptoms are defined according to the International Prostatic Symptom Score (IPSS)1.

1J Urology 1992;  148:1549-57.

Investigation Recommendations

A PSA determination is recommended for any man, with a life expectancy of 10 years or more, found to have a prostatic nodule on a digital rectal examination (DRE).

A PSA determination is recommended for any man, with a life expectancy of 10 years or more, where there is an increased suspicion of prostate cancer. Within the context of a suspicion of prostate cancer is an abnormal feeling prostate, focal lesion, discrete change in either texture, fullness or symmetry or secondary carcinoma of unknown origin.

A serum PSA determination may be considered for any man over the age of 40 years with a life expectancy of 10 years or more, who has a higher risk of prostate cancer. Within the context of higher risk is included a family history (first degree relative) of prostate cancer or men of African ancestry.

The use of a PSA test is recommended for men with moderate or severe symptoms of prostatism in whom treatment is contemplated.

A positive total PSA in the range of 4.0 - 10.0 µg/L should lead to consideration of measurement of the free and total serum PSA giving the F/T ratio in the diagnostic setting.

To avoid the patient having to return for a second specimen, and to avoid stability problems, free PSA should be measured in a "reflex" manner for PSA between 4 and 10 µg/L.

It is important that the laboratory store the specimen appropriately if free PSA is to be measured. Serum should be separated from cells within no more than 2 hours. Serum may be stored refrigerated for 24 - 48 hours (loss of activity occurs at a rate of about 2 - 4% per day).

It is also important that the laboratory use the same methodology for measurement of both total PSA and free PSA, and that the appropriate diagnostic points are validated for high probability of benign disease (usually >25% free PSA) and high probability of malignant disease (usually < 10% free PSA).

Investigation Recommendation graphic

* DRE  (Digital rectal examination)
Mildly suspicious: Slight asymmetry, minimal change in texture
Moderately suspicious: Marked asymmetry, obvious induration, nodularity
Highly suspicious: Hard mass

** PSA  (Prostate specific antigen)
Normal: Result within the normal range for method
Abnormal: Result outside the normal range for method

*** TRUS  (Trans-rectal ultrasound)

**** PSA  density is serum PSA level divided by TRUS determined prostate volume. An elevated density gives increased risk of prostate cancer.

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III. MONITORING

Using the PSA test to monitor patients with prostate cancer

The committee recommends the use of the PSA test to monitor patients with established cancer.

Monitoring Recommendation

The use of the PSA test is recommended to monitor patients with established cancer. The PSA test should not be repeated more often than once a month.

(Diagnosis of prostate cancer is based on positive biopsy)

Total PSA determination should be used to monitor for residual or recurrent PC after treatment by any of the current modalities except brachytherapy, where its role if any, is not yet established.

Currently there is no evidence that indicates benefit from ultrasensitive PSA measurements.

The free/total PSA ratio is of no benefit in monitoring patients with established PC.

In monitoring therapy, and in diagnosis, screening and staging of prostate cancer, Prostatic Acid Phosphatase (PAP) offers no benefit in addition to PSA. PAP may be useful in the rare patient whose tumour does not secrete PSA. This should be performed by the immunochemical method.

Monitoring Recommendation graphic

* DRE  (Digital rectal examination)
** PSA  (Prostate specific antigen)
Normal : Result within the normal range for method
Abnormal : Result outside the normal range of method

Note : These guidelines were prepared at the request of the Ministry of Health and Long-Term Care. They were developed by an expert panel representing laboratory medicine, oncology, urology, family medicine, radiology, and consumers. Quality Management Program Laboratory Services (QMP-LS) advised and assisted the panel.

Quality Management Program Laboratory Services (QMP-LS)      Ontario

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