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January 25, 1995, Vol 273, No. 4 >
ARTICLE | January 25, 1995

A Prospective Evaluation of Plasma Prostate-Specific Antigen for Detection of Prostatic Cancer FREE

Peter H. Gann, MD, ScD; Charles H. Hennekens, MD, DrPH; Meir J. Stampfer, MD, DrPH
[+] Author Affiliations

Reprint requests to Department of Preventive Medicine, Northwestern University Medical School, 680 N Lake Shore Dr, Suite 1102, Chicago, IL 60611 (Dr Gann).


JAMA. 1995;273(4):289-294. doi:10.1001/jama.1995.03520280035036
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References

Objective.  —To evaluate the validity of prostate-specific antigen (PSA) in identifying men who subsequently were or were not clinically diagnosed with prostate cancer, assess optimal test cutoff, measure lead time, and estimate relative risks (RRs) associated with discrete PSA levels.

Design.  —Nested case-control study of men providing plasma samples before a 10-year follow-up.

Setting.  —The Physicians' Health Study, an ongoing randomized trial that enrolled 22071 men aged 40 to 84 years in 1982.

Participants.  —A total of 366 men (cases) diagnosed with prostate cancer and 1098 men (three controls per case), matched by age, randomly selected from all cohort members at risk at the time of case diagnosis.

Main Outcome Measures.  —Sensitivity and specificity for each year of followup and for aggressive and nonaggressive cancers separately.

Results.  —At a cutoff of 4.0 ng/mL, sensitivity for the entire 10-year follow-up was 46% for total cases. Sensitivities for detection of total, aggressive, and nonaggressive cancers occurring in the first 4 years were 73%, 87%, and 53%. Overall, specificity was 91% and changed little by year of follow-up. Optimal validity was achieved at a cutoff of 3.3 ng/mL. Estimated mean lead time for all cancers was 5.5 years. Only 40% of cancers detected more than 5 years from baseline were nonaggressive. Compared with men with PSA levels less than 1.0 ng/mL, those with PSA levels between 2.0 and 3.0 ng/mL had an RR of 5.5 (95% confidence interval, 3.7 to 9.2).

Conclusions.  —A single PSA measurement had a relatively high sensitivity and specificity for detection of prostate cancers that arose within 4 years. Prostatespecific antigen values less than the usual cutoff were associated with substantial increases in risk compared with the lowest levels. Final evaluation of PSA screening must also consider cost and the ability of current treatments to improve the prognosis of screen-detected cases.(JAMA. 1995;273:289-294)

REFERENCES

1 +
Stamey TA, Yang N, Hay AR, McNeal JE, Freiha FS, Redwine E.  Prostate-specific antigen as a serum marker for adenocarcinoma of the prostate. N Engl J Med . 1987;;317:909-916.
2 +
Stamey TA, Kabalin JN, McNeal JE, et al.  Prostate specific antigen in the diagnosis and treatment of adenocarcinoma of the prostate, II: radical prostatectomy treated patients. J Urol . 1989;;141:1076-1083.
3 +
Mettlin C, Jones G, Averett H, Gusberg SB, Murphy GP.  Defining and updating the American Cancer Society guidelines for the cancer-related checkup. CA Cancer J Clin . 1993;;43:42-46.
4 +
American Urological Association Executive Committee Report, 1992 . Baltimore, Md: American Urological Association; May 1992;.
5 +
Mettlin C, Jones GW, Murphy GP.  Trends in prostate care in the United States, 1974-1990: observations from the patient care evaluation studies of the American College of Surgeons Commission on Cancer. CA Cancer J Clin. 1993;;43:83-91.
6 +
Holund B.  Latent prostatic cancer in a consecutive autopsy series. Scand J Urol Nephrol . 1980;; 14:29-35.
7 +
Lu-Yao GL, Greenberg ER.  Changes in prostate cancer incidence and treatment in USA. Lancet . 1994;;343:251-254.
8 +
Lu-Yao GL, McLerran D, Wasson J, Wennberg JE for the Prostate Patient Outcomes Research Team.  An assessment of radical prostatectomy. JAMA . 1993;;269:2633-2636.
9 +
Labrie F, Dupont A, Suburu R, et al.  Serum prostate specific antigen as pre-screening test for prostate cancer. J Urol . 1992;;147:846-852.
10 +
Cooner WH, Mosley BR, Rutherford CL Jr, et al.  Prostate cancer detection in a clinical urological practice by ultrasonography, digital rectal examination, and prostate specific antigen. J Urol . 1990;; 143:1146-1152.
11 +
Babaian RJ, Mettlin C, Kane R, et al.  The relationship of prostate-specific antigen to digital rectal examination and transrectal ultrasonograph. Cancer . 1992;;69:1195-1200.
12 +
Catalona WJ, Smith DS, Ratliff TL, et al.  Measurement of prostate-specific antigen in serum as a screening test for prostate cancer. N Engl J Med . 1991;;324:1156-1161.
13 +
Steering Committee of the Physicians' Health Study Research Group.  Final report on the aspirin component of the ongoing Physicians' Health Study. N Engl J Med . 1989;;321:129-135.
14 +
Liedtke RJ, Batjer JD.  Measurement of prostate-specific antigen by radioimmunoassay. Clin Chem . 1984;;30:649-652.
15 +
Hortin GL, Bahnson RR, Daft M, Chan K-M, Catalona WJ, Ladenson JH.  Differences in values obtained with 2 assays of prostate specific antigen. J Urol . 1988;;139:762-765.
16 +
Graves HCB, Wehner N, Stamey TA.  Comparison of a polyclonal and monoclonal immunoassay for PSA. J Urol . 1990;;144:1516-1522.
17 +
Catalona WJ.  Diagnosis, staging, and surgical treatment of prostatic carcinoma. Arch Intern Med . 1987;;147:361-363.
18 +
Chodak GW, Thisted RA, Gerber GS, et al.  Results of conservative management of clinically localized prostate cancer. N Engl J Med . 1994;;330: 242-248.
19 +
Helzlsouer KJ, Newby J, Comstock GW.  Prostate-specific antigen levels and subsequent prostate cancer: potential for screening. Cancer Epidemiol Biomarkers Prev . 1992;;1:537-540.
20 +
Carter HB, Pearson JD, Metter J, et al.  Longitudinal evaluation of prostate-specific antigen levels in men with and without prostate disease. JAMA . 1992;;267:2215-2220.
21 +
Murphy GP.  Report on the American Urologie Association/American Cancer Society Scientific Seminar on the Detection and Treatment of EarlyStage Prostate Cancer. CA Cancer J Clin . 1994;; 44:91-95.
22 +
Gormley GJ, Stoner E, Bruskewitz RC, et al.  The effect of finasteride in men with benign prostatic hyperplasia. N Engl J Med . 1992;;327:1185-1191.
23 +
Morrison AS. Screening in Chronic Disease . 2nd ed. New York, NY: Oxford University Press; 1992;.
24 +
Walter SD, Day NE.  Estimation of the duration of a preclinical disease state using screening data. Am J Epidemiol . 1983;;118:865-886.
25 +
Task Force appointed to the Conference of Deputy Ministers of Health.  Cervical cancer screening programs: the Walton Report. Can Med Assoc J . 1976;;114:1003-1033.
26 +
Walsh PC.  Why make an early diagnosis of prostate cancer. J Urol . 1992;;147:853-854.
27 +
Ruckle HC, Klee GG, Oesterling JE.  Prostatespecific antigen. Mayo Clin Proc . 1994;;69:59-68.
28 +
Epstein JI, Walsh PC, Carmichael M, Brendler CB.  Pathologic and clinical findings to predict tumor extent of nonpalpable (stage Tic) prostate cancer. JAMA . 1994;;271:368-374.

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1 +
Stamey TA, Yang N, Hay AR, McNeal JE, Freiha FS, Redwine E.  Prostate-specific antigen as a serum marker for adenocarcinoma of the prostate. N Engl J Med . 1987;;317:909-916.
2 +
Stamey TA, Kabalin JN, McNeal JE, et al.  Prostate specific antigen in the diagnosis and treatment of adenocarcinoma of the prostate, II: radical prostatectomy treated patients. J Urol . 1989;;141:1076-1083.
3 +
Mettlin C, Jones G, Averett H, Gusberg SB, Murphy GP.  Defining and updating the American Cancer Society guidelines for the cancer-related checkup. CA Cancer J Clin . 1993;;43:42-46.
4 +
American Urological Association Executive Committee Report, 1992 . Baltimore, Md: American Urological Association; May 1992;.
5 +
Mettlin C, Jones GW, Murphy GP.  Trends in prostate care in the United States, 1974-1990: observations from the patient care evaluation studies of the American College of Surgeons Commission on Cancer. CA Cancer J Clin. 1993;;43:83-91.
6 +
Holund B.  Latent prostatic cancer in a consecutive autopsy series. Scand J Urol Nephrol . 1980;; 14:29-35.
7 +
Lu-Yao GL, Greenberg ER.  Changes in prostate cancer incidence and treatment in USA. Lancet . 1994;;343:251-254.
8 +
Lu-Yao GL, McLerran D, Wasson J, Wennberg JE for the Prostate Patient Outcomes Research Team.  An assessment of radical prostatectomy. JAMA . 1993;;269:2633-2636.
9 +
Labrie F, Dupont A, Suburu R, et al.  Serum prostate specific antigen as pre-screening test for prostate cancer. J Urol . 1992;;147:846-852.
10 +
Cooner WH, Mosley BR, Rutherford CL Jr, et al.  Prostate cancer detection in a clinical urological practice by ultrasonography, digital rectal examination, and prostate specific antigen. J Urol . 1990;; 143:1146-1152.
11 +
Babaian RJ, Mettlin C, Kane R, et al.  The relationship of prostate-specific antigen to digital rectal examination and transrectal ultrasonograph. Cancer . 1992;;69:1195-1200.
12 +
Catalona WJ, Smith DS, Ratliff TL, et al.  Measurement of prostate-specific antigen in serum as a screening test for prostate cancer. N Engl J Med . 1991;;324:1156-1161.
13 +
Steering Committee of the Physicians' Health Study Research Group.  Final report on the aspirin component of the ongoing Physicians' Health Study. N Engl J Med . 1989;;321:129-135.
14 +
Liedtke RJ, Batjer JD.  Measurement of prostate-specific antigen by radioimmunoassay. Clin Chem . 1984;;30:649-652.
15 +
Hortin GL, Bahnson RR, Daft M, Chan K-M, Catalona WJ, Ladenson JH.  Differences in values obtained with 2 assays of prostate specific antigen. J Urol . 1988;;139:762-765.
16 +
Graves HCB, Wehner N, Stamey TA.  Comparison of a polyclonal and monoclonal immunoassay for PSA. J Urol . 1990;;144:1516-1522.
17 +
Catalona WJ.  Diagnosis, staging, and surgical treatment of prostatic carcinoma. Arch Intern Med . 1987;;147:361-363.
18 +
Chodak GW, Thisted RA, Gerber GS, et al.  Results of conservative management of clinically localized prostate cancer. N Engl J Med . 1994;;330: 242-248.
19 +
Helzlsouer KJ, Newby J, Comstock GW.  Prostate-specific antigen levels and subsequent prostate cancer: potential for screening. Cancer Epidemiol Biomarkers Prev . 1992;;1:537-540.
20 +
Carter HB, Pearson JD, Metter J, et al.  Longitudinal evaluation of prostate-specific antigen levels in men with and without prostate disease. JAMA . 1992;;267:2215-2220.
21 +
Murphy GP.  Report on the American Urologie Association/American Cancer Society Scientific Seminar on the Detection and Treatment of EarlyStage Prostate Cancer. CA Cancer J Clin . 1994;; 44:91-95.
22 +
Gormley GJ, Stoner E, Bruskewitz RC, et al.  The effect of finasteride in men with benign prostatic hyperplasia. N Engl J Med . 1992;;327:1185-1191.
23 +
Morrison AS. Screening in Chronic Disease . 2nd ed. New York, NY: Oxford University Press; 1992;.
24 +
Walter SD, Day NE.  Estimation of the duration of a preclinical disease state using screening data. Am J Epidemiol . 1983;;118:865-886.
25 +
Task Force appointed to the Conference of Deputy Ministers of Health.  Cervical cancer screening programs: the Walton Report. Can Med Assoc J . 1976;;114:1003-1033.
26 +
Walsh PC.  Why make an early diagnosis of prostate cancer. J Urol . 1992;;147:853-854.
27 +
Ruckle HC, Klee GG, Oesterling JE.  Prostatespecific antigen. Mayo Clin Proc . 1994;;69:59-68.
28 +
Epstein JI, Walsh PC, Carmichael M, Brendler CB.  Pathologic and clinical findings to predict tumor extent of nonpalpable (stage Tic) prostate cancer. JAMA . 1994;;271:368-374.

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