Prevalence of Prostate Cancer among Men with a Prostate-Specific Antigen Level ≤4.0 ng per Milliliter
- Study type
- Observational study
- Study name
- PCPT
- Design
- Secondary analysis of the placebo group of the Prostate Cancer Prevention Trial; assessment of cancer prevalence on end-of-study biopsy
- Sample size
- 2950 men
- Source
- N Engl J Med · 2004
In plain words
In this study, men whose PSA was in the "normal" range (4.0 or lower) had a biopsy after seven years, and about 15% of them had prostate cancer. Even some men with low PSA had higher-risk cancers, although the higher the PSA, the greater the chance of cancer. So a normal PSA does not mean prostate cancer is definitely absent. Decisions about screening and follow-up should be made with your doctor.
Key results
Treatment arms and regimens
Received placebo (control group of the PCPT prevention trial); annual PSA measurement and digital rectal examination; prostate biopsy at the end of 7 years in the study.
Source of the regimen details: Abstract of the paper (prevalence analysis; no drug regimen)
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Study population
Of the 18,882 men enrolled in the prevention trial, 9459 were randomly assigned to placebo and had annual PSA testing and digital rectal examination (DRE). Of these 9459, 2950 men were included in the analysis; they had never had a PSA above 4.0 ng/mL or an abnormal DRE, had a final PSA measurement and underwent prostate biopsy after seven years in the study. The age range of these 2950 men was 62 to 91 years.
Endpoints
Prevalence of prostate cancer on biopsy, including high-grade cancers (Gleason score 7 or higher), by PSA level in men with a PSA of 4.0 ng/mL or less.
Safety and side effects
This was a prevalence analysis and the abstract reports no adverse event data.
Clinical significance and place in guidelines
This study showed that 4.0 ng/mL is not a definite cut-off between the presence and absence of prostate cancer, and that cancer, including high-grade disease, is also found in the "normal" PSA range. The abstract gives no information on changes to clinical recommendations or guideline endorsements; its place in current screening guidelines should be checked separately.
Limitations
Based on the abstract: the analysis included only men who had a final PSA and a biopsy at the end of seven years and never had a PSA above 4.0 or an abnormal DRE, so it may not represent the whole population. The data came from the placebo group of a prevention trial with an age range of 62 to 91 years. The abstract does not address long-term clinical outcomes (such as the clinical significance of the cancers found). A correction has been published for this paper (N Engl J Med 2004;351:1470) and should be checked in the full text.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.