Prostate Cancer Screening with - CHAMPS Online



Prostate Cancer Screening with

Serum Prostatic Specific Antigen (PSA)

Approved by the Prevention Department December 2003

Approved by SQRMC January 2004

|These guidelines are informational only and are not intended to substitute for the reasonable exercise of independent clinical |

|judgment of the providers using the guideline. The guidelines are to be used in conjuction with the provider's clinical judgment |

|in developing care and treatment that is designed for the individual needs of the patient. |

Target Population

All men ages 50 and older who have no prostate related symptoms.

Settings for Application

Departments of Internal Medicine, Family Practice, Urology.

Rationale for Guideline

Periodic PSA screening for prostate cancer in men age 50 years and older has been advocated by several external groups including the American Cancer Society and the American Urology Association. Unfortunately, there is no rigorous evidence that PSA screening will reduce mortality from prostate cancer or that a population screening program provides more benefit than harm. Media attention has elevated the visibility of this test, and state law requires coverage. The responsible approach, supported by many experts in prostate cancer, is to allow our members to make informed decisions about whether or not they wish to have PSA screening.

The following evidence-based guideline was developed to help primary care physicians and other health care professionals use the PSA test in asymptomatic men. It does not apply to men who have signs or symptoms of prostate disease, or in whom a diagnosis has already been made.

Recommendations

• There is currently inconclusive evidence to recommend for or against use of the PSA test for prostate cancer screening in asymptomatic men.

Methodology: Evidence based.

• For patients interested in PSA screening, the potential risks and benefits of the test should be discussed with the patient. If a man understands the potential benefits and risks of the PSA test and requests it, he should be given the test.

Methodology: Consensus based.

• The discussion may include the following points:

1. It is not yet known whether use of the PSA test for prostate cancer screening is beneficial. Large, randomized controlled trials are in progress; results are not expected for several years.

2. If a cancer is present, the PSA test will have between a 77-98% chance of detecting it. The false-positive rate of the PSA test is between 3% and 23%.

3. If a cancer is detected, it may or may not ever become clinically significant in a man’s lifetime.

4. The overall survival benefit of treatment for prostate cancer found as a result of PSA screening is uncertain. Treatments have potential risks and potential benefits.

Methodology: Evidence based.

• If PSA Screening is requested, the appropriate age at which to start and stop screening as well as the frequency of screening is unknown. The following is recommended for men requesting screening:

1. For men who are thought to be at high risk of prostate cancer, PSA screening may be considered beginning at age 45. This includes men who:

o Are of African-American descent, and/or

o Have one or more first-degree relatives (father or brother) diagnosed with prostate cancer.

2. For all other men, PSA screening may be considered beginning at age 50.

3. For men with a life expectancy less than 10 years, either because of advanced age (70 years or greater) or serious comorbid medical conditions, PSA screening is not recommended.

4. Routine PSA screening should not be performed more than once per year.

5. A digital rectal exam (DRE) should be performed with the PSA test

6. The PSA thresholds for which referral to Urology may be considered are indicated in Table 1.

Methodology: Consensus based.

It is recommended that the provider document in the medical record that information on PSA screening has been provided to the patient or that PSA screening has been discussed if the patient decides to be screened.

Table 1: Age-Specific PSA Thresholds for Referral to Urology*

|Age |Threshold |

|45 to 49 |>2.5 ng/mL |

|50 to 59 |>3.5 ng/mL |

|60 to 69 |>4.5 ng/mL |

|70 to 79 |>6.5 ng/mL |

Free PSA Test

• There is insufficient evidence to recommend for or against the use of the free PSA test in asymptomatic men with persistent, mildly elevated total-PSA (4-10ng/mL).

• Use of the free PSA test for follow-up of an abnormal total PSA result should be determined by specialists in Urology.

Epidemiology of Prostate Cancer

• For both whites and blacks, prostate cancer incidence increases sharply between the ages of 45 and 49. Age-adjusted incidence at age 45-49 is 32.4 and 89.3 per 100,000 for whites and blacks respectively; it peaks at age 70-74 with rates of 1072.5 and 1622.4 for whites and blacks, respectively. (See Table 2).

• Age adjusted mortality rates for prostate cancer are low for both whites and blacks between the ages of 40 and 49. Mortality at age 40-44 is 0.2 and 0.7 per 100,000 in whites and blacks respectively; at age 45-49 it is 0.8 and 2.7 respectively. (See Table 2)

• Asian-American and Hispanic men have incidence rates lower than non-Hispanic white men

• The median age at diagnosis is approximately 71 years, and the median age at death is 78 years.1

• More than 75% of all cases of prostate cancer are diagnosed in men older than 65 years of age, and 90% of deaths occur in this age group. 1

Prostate Cancer Screening Dilemma

• Autopsy studies show that approximately one third of men older than 50 years have foci of prostate cancer that are not clinically evident.

• Less than 1 in 30 prostate cancers will cause death.

• Current screening measures cannot differentiate aggressive, malignant lesions from non-aggressive "incidental" cancers.

Prostate-Specific Antigen (PSA) as a Screening Test

• PSA screening will increase case findings of both clinically significant and incidental cancers.

• PSA screening has a specificity of approximately 59%, resulting in numerous false-positive tests and negative biopsies. 2

• PSA screening has not been proven to directly decrease mortality from prostate cancer.

• PSA screening has a positive predictive value ranging from 13-50%. 3

Table 2: Age-adjusted Incidence and Mortality Rates (Per 100,000) for Prostate Cancer, By Race

|AGE AT |INCIDENCE |MORTALITY |

|DIAGNOSIS | | |

|  |White Males |Black Males |White Males |Black Males |

|40-44 |6.6 |20.3 |0.2 |0.7 |

|45-49 |32.4 |89.3 |0.8 |2.7 |

|50-54 |132.6 |259.4 |2.8 |9.7 |

|55-59 |321.5 |580 |8.8 |28.3 |

|60-64 |587.3 |1009.6 |22.1 |73.4 |

|65-69 |910.4 |1401.6 |52.4 |152 |

|70-74 |1072.5 |1622.4 |104.6 |313.6 |

|75-79 |1053.2 |1580.9 |197.5 |519 |

|80-84 |910.7 |1259.9 |354.8 |848.1 |

|85+ |801.7 |1148.0 |677.2 |1354.1 |

|All Ages |171.2 |274.3 |28.8 |70.4 |

|(0-85+) | | | | |

Source: SEER Cancer Statistics Review 1997-2001.

Consequences of PSA Screening

• For men who have an elevated PSA, multiple prostate biopsies may be performed.

• Men with positive biopsies may choose between many therapies that have potential risks and benefits. Based on data collected over the last 20 years, Table 3 provides risk estimates for the most common standard approaches to prostate cancer treatment.

What Your Patient Needs to Know if He Decides to Have PSA Screening

• Screening for prostate cancer in men whose life expectancy is less than 10 years (i.e. due to advanced age and/or medical co-morbidity) is of questionable value.

• PSA screening has not been shown to decrease mortality from prostate cancer.

• In the scientific literature, opinion is divided on the role of PSA screening.

• It is unknown if a cancer found by PSA screening will be clinically important.

• Whenever a patient undergoes a biopsy of the prostate, there may be potential complications associated with the biopsy.

• Patients with acute prostatitis, cystitis or catheterization should not receive a PSA test until at least 3 months after these conditions have cleared.

Table 3: Estimates of Risks, By Type of Prostate Cancer Treatment

TREATMENT |Sexual

Dysfunction/  Impotence |Incontinence |Urinary

Stricture |Mortality (Surgical) |Rectal Injury |Osteoporosis, weight gain, hot flashes |Acute Urinary Retention |Cystitis, Urethritis, Proctitis | |Radical

Prostatectomy |27-80% 5,6,7,8 |3-62% 5,6,7,8 |18% 5 | ................
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