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Thompson IM, Ankerst DP, Chi C, et al. Operating Characteristics of Prostate-Specific Antigen in Men With
an Initial PSA Level of 3.0 ng/mL or Lower. JAMA. 2005;294(1):66–70. doi:10.1001/jama.294.1.66
Author Affiliations: Department of Urology,
University of Texas Health Science Center at San Antonio (Dr Thompson); Fred
Hutchinson Cancer Research Center, Seattle, Wash (Dr Ankerst and Mss Chi and
Goodman); University of Colorado, Denver (Dr Lucia); Cancer Research and Biostatistics,
Seattle (Dr Crowley); National Cancer Institute, National Institutes of Health,
Bethesda, Md (Dr Parnes); and Southwest Oncology Group, San Antonio (Dr Coltman).
Context Three fourths of US men older than 50 years have been screened with
prostate-specific antigen (PSA) for prostate cancer.
Objective To estimate the receiver operating characteristic (ROC) curve for PSA.
Design, Setting, and Participants Calculation of PSA ROC curves in the placebo group of the Prostate Cancer
Prevention Trial, a randomized, prospective study conducted from 1993 to 2003
at 221 US centers. Participants were 18 882 healthy men aged 55 years
or older without prostate cancer and with PSA levels less than or equal to
3.0 ng/mL and normal digital rectal examination results, followed up for 7
years with annual PSA measurement and digital rectal examination. If PSA level
exceeded 4.0 ng/mL or rectal examination result was abnormal, a prostate biopsy
was recommended. After 7 years of study participation, an end-of-study prostate
biopsy was recommended in all cancer-free men.
Main Outcome Measures Operating characteristics of PSA for prostate cancer detection, including
sensitivity, specificity, and ROC curve.
Results Of 8575 men in the placebo group with at least 1 PSA measurement and
digital rectal examination in the same year, 5587 (65.2%) had had at least
1 biopsy; of these, 1225 (21.9%) were diagnosed with prostate cancer. Of 1213
cancers with Gleason grade recorded, 250 (20.6%) were Gleason grade 7 or greater
and 57 (4.7%) were Gleason grade 8 or greater. The areas under the ROC curve
(AUC) for PSA to discriminate any prostate cancer vs no cancer, Gleason grade
7 or greater cancer vs no or lower-grade cancer, and Gleason grade 8 or greater
cancer vs no or lower-grade cancer were 0.678 (95% confidence interval [CI],
0.666-0.689), 0.782 (95% CI, 0.748-0.816), and 0.827 (95% CI, 0.761-0.893),
respectively (all P values <.001 for AUC vs 50%).
For detecting any prostate cancer, PSA cutoff values of 1.1, 2.1, 3.1, and
4.1 ng/mL yielded sensitivities of 83.4%, 52.6%, 32.2%, and 20.5%, and specificities
of 38.9%, 72.5%, 86.7%, and 93.8%, respectively. Age-stratified analyses showed
slightly better performance of PSA in men younger than 70 years vs those 70
years or older with AUC values of 0.699 (SD, 0.013) vs 0.663 (SD, 0.013) (P = .03).
Conclusion There is no cutpoint of PSA with simultaneous high sensitivity and high
specificity for monitoring healthy men for prostate cancer, but rather a continuum
of prostate cancer risk at all values of PSA.
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