Ch. Harris et al., PROSPECTIVE LONGITUDINAL EVALUATION OF MEN WITH INITIAL PROSTATE-SPECIFIC ANTIGEN LEVELS OF 4.0 NG ML OR LESS/, The Journal of urology, 157(5), 1997, pp. 1740-1743
Purpose: We evaluated the 3-year longitudinal changes in serial serum
prostate specific antigen (PSA) levels in men with an initial PSA of 4
.0 ng./ml. or less and no suspicion of prostate cancer. Materials and
Methods: A total of 760 men with an initial PSA of 4.0 ng./ml. or less
plus a normal or suspicious digital rectal examination and a benign p
rostate biopsy was enrolled into an every 4-month PSA monitoring study
. Results: Of the 559 men with an initial PSA of 2.0 ng./ml. or less o
nly 3 (0.5%) had a persistently abnormal PSA for 3 years and 1 cancer
(0.2%) was detected, and 48 men had a PSA velocity of 0.8 ng./ml. per
year or more at year 1 but only 1 (2%) had a persistent rate of increa
se (2.4 ng./ml. per year) at 3 years. Of the 201 men with a PSA of 2.1
to 4.0 ng./ml. 85 had an abnormal PSA but only 37 (43%) met the crite
ria for biopsy. Only 8 of 23 biopsies (35%) revealed cancer. Of the 20
1 men 24 had a PSA velocity of 0.8 ng./ml. per year or more at year 1
but only 4 had persistence for 3 years. All 4 men had cancer but they
were identified as at high risk by PSA criteria. Conclusions: Men with
a PSA of 2.0 ng./ml. or less are at low risk for an abnormal PSA or c
ancer within 3 years and annual monitoring may not be necessary. Howev
er, annual monitoring is clinically useful in men with an initial PSA
of 2.1 to 4.0 ng./ml. Also, serial monitoring with interval testing in
men whose PSA becomes greater than 4.0 ng./ml. is beneficial in ident
ifying a high risk group requiring biopsy. Finally, PSA velocity did n
ot add further to cancer detection in this population.