Prostate needle biopsy quality in reduction by dutasteride of prostate cancer
events study: worldwide comparison of improvement with investigator training and
centralized laboratory processing.
Author(s): Bostwick DG, Qian J, Drewnowska K, Varvel S, Bostwick KC, Marberger M, Rittmaster
RS.
Affiliation(s): Bostwick Laboratories, Glen Allen, Virginia 23060, USA.
dboswick@boswicklaboratories.com
Publication date & source: 2010, Urology. , 75(6):1406-10
OBJECTIVES: To compare biopsy quality factors among study sites worldwide at
entry and at year 2 in the reduction by dutasteride of prostate cancer events
study. The accuracy of prostate cancer detection is influenced by the length and
number of biopsy cores.
METHODS: Biopsy quality factors at entry and at year 2 were compared for subjects
enrolled from 6 geographic regions: North America, South America, Western Europe,
Central/Eastern Europe, Australia, and Africa. Investigator training was provided
for prostate biopsy collection before year 2, emphasizing core length and number
of cores obtained.
RESULTS: Data were collected prospectively from 4649 subjects at entry and 6267
subjects at year 2. At entry, the aggregate length, number of cores, and mean
length of cores differed significantly among regions. Aggregate length was
longest in biopsies from Australia, and number of cores was highest from South
America. At year 2, each region collected the protocol-required 10 cores, and
aggregate length and mean length of cores were greater than for entry biopsies;
site variance was reduced for all factors.
CONCLUSIONS: There were significant differences in aggregate length, number of
cores, and mean length of cores among regions at study entry. After investigator
training by the study sponsor and use of a central laboratory for standardized
processing, year 2 biopsies showed an increase in all 3 quality factors when
compared with entry biopsies. Variance in biopsy quality can be reduced by
investigator training and standardization of collection and processing, thereby
optimizing detection of cancer. Biopsy quality may be a useful comparative
measure in urologic practice.
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