Informed consent form to make a decision to be tested or not with PSA. Feel free to provide input. Email us at: This e-mail address is being protected from spambots. You need JavaScript enabled to view it  

Patient's information for an informed consent decision: PSA/DRE testing for prostate cancer

Read this information carefully before deciding whether to be tested or not.

1. At present, doctors are divided over the advisability of screening (testing with PSA and DRE) in an asymptomatic man. As a result, each man should be informed of the potential risks and benefits before deciding if he wants to be tested or not.
2. The decision about having the PSA and DRE depends on each man's goals, fears and willingness to accept risk. There is risk in taking the test and detecting cancer and getting treated with potentially unpleasant side effects.  There is also risk in deciding against the test, since prostate cancer has very few symptoms and the disease can be advanced and incurable before detected at a later point.
3. The decision is yours.  Learn as much as possible before deciding.

AGAINST TESTING STATEMENTS:

Studies that will assess the value of screening (testing with PSA and DRE) are underway but will not be completed for 5 to 10 years.

At present, there are no completed randomized clinical trials to demonstrate that screening (testing with PSA and DRE) can reduce a man's chances of dying or suffering from prostate cancer.

There are studies in progress that demonstrate preliminary evidence that early detection and effective treatment can alter the natural course of the disease and improve survival.

Many men who have prostate cancer will die from other causes without suffering any effects from the disease. Therefore neither screening (testing with PSA and DRE) nor treatment is necessary or beneficial to them.

Current treatments may cause unpleasant side effects in some men. Some more than others. Incontinence and impotence are among the most prevalent.

Improving early detection is not a guarantee that cancer deaths will be prevented. Studies are underway, but not available at this time.

No screening (testing with PSA and DRE) is the best way to maximize a man's quality of life, as long as you understand that the disease might continue to progress, ultimately demonstrate symptoms and could eventually, if you live long enough, kill you or result in an advanced diagnosis.

The biggest benefit of testing is in men with a life expectancy of 10 to 15 years. As men get older this benefit decreases.

The actual test (PSA/DRE) is usually harmless. If the results are abnormal, you might be offered a biopsy. This test can lead to detection of prostate cancer and further treatment complications.

PRO TESTING STATEMENTS:

Prostate cancer is a progressive disease with few symptoms and many times without any symptoms, so you could have prostate cancer without having symptoms.

The disease is more prevalent with advancing age. Men should be aware of this as early as possible to be able to make an informed decision. The age of increased risk is 50 for whites or 45 for blacks. Men who have a father or brother diagnosed with prostate cancer and African-American men are at higher risk to develop prostate cancer should be screened at age 40 or less.

Presently, 42% of men older than 50 years will have prostate cancer during their lifetime, 9.5% will have disease that causes problems and is considered clinically significant and 2.9% will die of the disease.

Prostate cancer contained within the prostate is potentially curable. Early-stage prostate cancer is usually contained within the prostate. Prostate cancer that has extended beyond the prostate, called advanced prostate cancer, is considered incurable at the present time.

At least three studies have demonstrated that early detection and effective treatment has resulted in a survival benefit by altering the natural course of the disease.

A blood test, called Prostate-Specific Antigen, - PSA - can detect prostate cancer. The value of this test is that by serial testing it can predict the incidence of cancer well ahead of the disease demonstrating clinical significance. PSA/DRE testing improves early detection of prostate cancer, especially in men without symptoms.

Since the inception of PSA and DRE use there has been a 32.5 % reduction in prostate cancer mortality between 1993 and 2003. This reduction remains unexplained.

The real value of the PSA/DRE test combination is to establish a baseline measurement and then do periodic measurements. If the measurements vary considerably from year to year, this warrants investigation (variation of 0.75 ng/ml or more in PSA). A recent study demonstrated that men with PSA velocities of more than 0.35 ng/ml per year had a higher relative risk of prostate cancer death than men with PSA velocity of 0.35 ng/mL per year or less (RR = 4.7, 95% CI = 1.3 to 16.5; P = .02)

Without PSA and DRE testing, a high percentage of men are diagnosed with advanced prostate cancer, incurable disease, rather than being diagnosed earlier, with potentially curable disease.

I, ___(signature)______________________ have read this information and after evaluation
have decided to:     Defer test ( )     Accept test ( )

This material has been prepared with the available information current at this time. The intent is to motivate men to understand the benefit/risk value of PSA/DRE testing and decide for or against the test. Prepared by Ralph Valle, Prostate Cancer Survivor. Phoenix, Arizona.