Screening for Prostate Cancer: A Review of the Evidence for the U.S. Preventive Services Task ForceFREE
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Abstract
Background:
Purpose:
Data Sources:
Study Selection:
Data Extraction:
Data Synthesis:
Limitations:
Conclusion:
Primary Funding Source:
Methods
Scope of the Review
Data Sources and Searches
Study Selection
Data Extraction and Quality Assessment
Data Synthesis and Analysis
Role of the Funding Source
Results
Key Question 1: Does PSA-Based Screening Decrease Prostate Cancer–Specific or All-Cause Mortality?
Key Question 2: What Are the Harms of PSA-Based Screening for Prostate Cancer?
Key Question 3: What Are the Benefits of Treatment of Early-Stage or Screening-Detected Prostate Cancer?
Prostatectomy
Radiation Therapy
Key Question 4: What Are the Harms of Treatment of Early-Stage or Screening-Detected Prostate Cancer?
Prostatectomy
Urinary Incontinence and Erectile Dysfunction.
Quality of Life.
Surgical Complications.
Other Harms.
Radiation Therapy
Urinary Incontinence and Erectile Dysfunction.
Quality of Life.
Other Harms.
Discussion
References
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Screening for Prostate Cancer: A Review of the Evidence for the U.S. Preventive Services Task Force. Ann Intern Med.2011;155:762-771. [Epub 6 December 2011]. doi:10.7326/0003-4819-155-11-201112060-00375
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USPSTF needs to consider another endpoint besides mortality
While there is much to applaud in the task force's report, I think their conclusions may do more harm than good. They have studied mortality as a primary endpoint. As an elderly urologist who spent almost half of his career in the pre-PSA era, I can personally attest to another and perhaps even more important factor that is being overlooked: that of suffering from advanced prostate cancer.
No longer do I see patients with bulky cancers who bleed and obstruct their urinary tracts. Many of these patients required emergency procedures and were left with permanent indewelling catheters. The patient presenting with diffuse painful osseous metastasis is now rare. Performing emergency orchiectomies plus radiation or surgical decompression for impending paraplegia seems less common.
Patients like these could live for years and still die of other diseases. They will not register as a success of PSA screening if only mortality is considered. In one study that studied the presence of metastasis as the primary endpoint, screened patients experienced a 48% reduction in the number of patients developing metastatic disease.1
The task force has made some excellent points. The AUA has modified its guidelines to take into account the evidence as it has emerged. More judicious use of PSA and recommendations for treatment of early cancer are necessary. Better methods for distinguishing those cancers destined to spread or kill need to be developed. However, if the task force's conclusions are interpreted by the public at large as a condemnation of early diagnosis of prostate cancer using PSA, we will be thrown back to the era when digital rectal exams diagnosed dangerous cancers too late.
Respectfully, Murray S. Feldstein M.D. Phoenix Arizona
Reference
1. Aus G, Bergdahl S, Lodding P., Lilja H, Hugosson J; Prostate cancer screening decreases the absolute risk of being diagnosed with advanced prostate cancer--results from a prospective, population-based randomized controlled trial. Eur J Urol 51: 659-64, 2007
Conflict of Interest:
Urologist
Need to Consider Racial Diversity of American Population
To the Editor:
I am disheartened by the publication of "Screening for Prostate Cancer: A Review of the Evidence for the U.S. Preventive Services Task Force" which suggests PSA screening is ineffective and harmful to American men. I do not believe the "exhaustive review of the latest eveidence" dscribed by the authors is applicable to American men.
American Cancer Society Cancer Fact and Figures for African Americans 2011-12 continue to report that 35,110 cases of prostate cancer are expected to occur in AA men, accounting for 40% of all cancer diagnosed in AA men. One in five men will be diagnosed with prostate cancer in their lifetime. The average annual prostate cancer incidence rate among AA men (2003-2007) was 229.4/100,000 men, 60% higher than white men. AA men have the highest incidence rate in the world and are twice as likely to die of prostate cancer than whites.
2010 Census shows the U.S. population racial distribution is whites 79%, African Americans 13.8%, Asicans 4% and Hispanic ethnicity is reported at 12.5%.
The seven articles chosen from the 379 articles retrieved as meeting inclusion criteria for determination of the effectiveness of PSA screening (Table 1) are derived from predominantly Caucasian men of northern or western European heritage (predominantly Scandinavia). Several of these studies re-analyze the same cohorts or portions of previously reported cohorts. Thus, the data is mainly derived from the ERSPC and PLCO studies. The PLCO study was the only one to include American men and to report race/ethnicity. It included African Americans (4.5%), Asians (4.0%), Hispanics (2.1%) and Pacific Islanders/Native Americans (0.8%) and thus is not fully representative of the U.S. population. This same study has been oft criticized due to the contamination of the control group (those not undergoing PSA testing within the study) of whom 44% had undergone a PSA blood test prior to enrolling, and 52% who had PSA testing done outside the study during follow-up.
I remain unconvinced that these recommendations are applicable to anyone other than Scandinavian men over the age of 50 years. Adopting them without considering the increasing racial diversity of the American population seems unwise.
Conflict of Interest:
None declared
Errors of fact, statistics and interpretation in the USPSTF review on prostate cancer screening
By giving a grade of "D" for prostate cancer screening, the U.S. Preventive Services Task Force (USPSTF) concluded that "there is moderate or high certainty that [prostate cancer screening] has no net benefit or that the harms outweigh the benefits". We have sympathy with the recommendations against current screening practices in the U.S. However, the report from the USPSTF contained important errors of fact, interpretation or statistics.
Firstly, the largest trial of PSA screening, the European Randomized study of Screening for Prostate Cancer (ERSPC) has not yet reported at its pre-specified main follow-up time. To draw conclusions that screening results "in small or no reduction in prostate cancer-specific mortality", suggests that definitive conclusions of no benefit can be drawn from an ongoing trial with ambiguous results at interim follow-up. Further, data on overall mortality from early follow-up of a screening trial cannot be used to conclude that "screening does not save lives" as screening trials lack necessary statistical power to address this issue.
The USPSTF conclusions appear importantly based on the validity of the pooling in two meta-analyses. The two largest and most high-quality studies are the U.S. Prostate, Lung, Colorectal and Ovarian Cancer trial (PLCO) and the ERSPC. However, PSA-testing was widespread before the PLCO trial and in the control group throughout the study. Therefore, the authors of this trial stated that the trial "would not be able to answer the question of whether that level of opportunistic screening is conveying a mortality benefit over no screening".[1] Contamination in ERSPC was less than 15%[2]. It is very hard to justify combining a trial of opportunistic vs. systematic screening with a trial of systematic vs. no screening and then calculate an "average" effect.
The USPSTF authors state "48 men received treatment for every prostate cancer-specific death prevented". This is false: the number was calculated from the number of men diagnosed, not the number treated. Moreover, this statistic depends on the length of follow-up. Models have estimated this ratio to be around 20 at 12 years of-follow-up in the ERSPC[3]; the empirical estimate from the Goteborg trial with 14 years of follow-up is 12[4].
In conclusion, although fair-quality trials have demonstrated an ability of screening to prevent prostate cancer death by 20-44%[4,5], it is not unreasonable to recommend against the current modality to practice PSA screening based on the harms associated with over-diagnosis and risk of toxicity associated with treatment.
References
[1.] Pinsky PF, Blacka A, Kramer BS, Miller A, Prorok PC, Berg C. Assessing contamination and compliance in the prostate component of the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial. Clinical trials. 2010;7(4):303-311.
[2.] Schroder FH, Roobol MJ. ERSPC and PLCO prostate cancer screening studies: what are the differences? Eur Urol. 2010;58(1):46-52.
[3.] Loeb S, Vonesh EF, Metter EJ, Carter HB, Gann PH, Catalona WJ. What is the true number needed to screen and treat to save a life with prostate -specific antigen testing? J Clin Oncol. 2011;29(4):464-467.
[4.] Hugosson J, Carlsson S, Aus G, et al. Mortality results from the Goteborg randomised population-based prostate-cancer screening trial. Lancet Oncol. 2010;11(8):725-732.
[5.] Schroder FH, Hugosson J, Roobol MJ, et al. Screening and prostate- cancer mortality in a randomized European study. N Engl J Med. 2009;360(13):1320-1328.
Conflict of Interest:
Conflict of Interest: Dr. Hans Lilja holds patents for free PSA, hK2, and intact PSA assays. Authors affiliations: 1. Sigrid Carlsson MD PhD, Department of surgery (Urology), Memorial Sloan-Kettering Cancer Center, New York, U.S.A. and Department of Urology, Sahlgrenska Academy at Goteborg University, Goteborg, Sweden. 2. Andrew Vickers Ph.D. Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, NY. 3. Hans Lilja MD PhD Attending, Departments of Laboratory Medicine, Surgery (Urology), and Medicine (GU-Oncology), Memorial Sloan-Kettering Cancer Center, New York, USA and Professor (adjunct) Department of Laboratory Medicine, Lund University, Sweden, and Institute of Biomedical Technlogy, University of Tampere, Finland 4. Jonas Hugosson. MD, PhD, Professor, Department of Urology, Sahlgrenska Academy at Goteborg University, Goteborg, Sweden