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In 2002, Annals published a systematic review that addressed several issues relevant to prostate cancer screening (1). Based on the review, the U.S. Preventive Services Task Force gave prostate cancer screening a grade I recommendation, which means that the members thought that the evidence about the balance of benefits and harms of screening was insufficient to make a stronger recommendation (2). The Task Force had the following concerns: 1) There was only “mixed and inconclusive” evidence that early treatment of prostate cancer could prevent adverse outcomes and 2) treatment was associated with a high risk for substantial harm, principally urinary incontinence and erectile dysfunction. The Task Force suggested that physicians inform men older than 50 years of age about the uncertainty of the evidence for net benefit and that they help men reach individual, informed decisions about screening.
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Response to: An editorial update: Should benefits of radical prostatectomy affect the decision to screen for early prostate cancer? (1).
Your update recommends radical prostatectomy for all early prostate cancer patients younger then age 65(1). Your conclusion is based on a flawed Swedish randomized trial, which compared radical prostatectomy with watchful waiting for men with clinically detected prostate cancer(2). The trial results concluded that radical prostatectomy reduces disease-specific mortality, overall mortality, and the risks of metastases and local progression.
The trial flaws included selection bias, lack of masking and unsupported sub group analysis. The initial study group was not properly randomized; because the investigators knew which patient was to have surgery prior to randomization. The protocol initially stated that ONLY the selected surgery patients were given a fully informed consent, while the watchful waiting patients were not fully informed (3). "After oral informed consent was received from eligible patients, they were randomly assigned to undergo either radical prostatectomy or watchful waiting through a telephone service (2). How can you randomize patients, when the surgical patients have been preselected?
Two years into the trial, the investigators modified the protocol by giving all patients a fully informed consent. However, the first compromised group of 68 men was included in the entire study group of 347 men. This selection bias and lack of masking violated the rules of a randomized trial.
In the subgroup analysis of the trial, the benefits of radical prostatectomy were related to the below 65 age group, but not to the PSA level or Gleason score at diagnosis. The three most powerful studies state that the Gleason score is the most significant predictor of biochemical failure and cancer-specific mortality (4,5,6). The trial results do not agree with the consensus of most urologists.
Advocating mass screening based on one flawed trial will subject millions of men to unwarranted biopsy and radical local treatment with unproven efficacy (7). Therefore, the US Preventative Services Task Force recommendation against mass screening for prostate cancer should continue to be followed(8).
1. Sox HC. An editorial update: Should benefits of radical prostatectomy affect the decision to screen for early prostate cancer. Ann Intern Med. 2005;143:232.
2. Bill-Axelson A, Holmberg L, Ruutu M, Haggman M, Andersson SO, Bratell S, et al. Radical prostatectomy versus watchful waiting in early prostate cancer.
N Engl J Med. 2005;352:1977
3. Bill-Axelson A, Holmberg L, Ruutu M,et al. Protocol accessed at www.nejm.org. N Engl J Med. 2005;352:1977. Information to patients, pp.15 -16.
4. Albertsen PC, Hanley JA, Fine J. 20 year outcomes following conservative management of clinically localized prostate cancer. JAMA. 2005;293:2095.
5. Freedland SJ, Humphreys BS, Mangold LA, Walsh PC, Partin AW, et al. Risk of prostate cancer-specific mortality following biochemical recurrence after radical prostatectomy. JAMA. 2005;294:433
6. Tollefson MK, Leibovich BC, Slezak JM, Blute ML. Long term significance of primary Gleason pattern in patients with Gleason score 7 prostate cancer. Impact on prostate cancer specific survival. J Urol. 2006;175:547
7. Welch HG, Schwartz LM, Woloshin S. Prostate-specific antigens levels in the United States: Implications of various definitions for abnormal. JNCI. 2005;97:1132
8. Harris R, Lohr KN. Screening for prostate cancer: An update of the evidence for the U.S. Preventive Task Force. Ann Intern Med. 2002;137:917
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