Collaborative Review – Prostate CancerOptimizing Performance and Interpretation of Prostate Biopsy: A Critical Analysis of the Literature
Introduction
The early detection of prostate cancer (PCa) should be aimed at diagnosing significant disease at a curable state. Within the past 2 decades, substantial improvements in early detection have been achieved [1], [2]. For example, the increased use of prostate-specific antigen (PSA) has resulted in so-called stage migration, shifting the proportion of pathologically localized curable disease from 20% to 30% in the pre-PSA era to about 70–80% currently [3].
Despite this significant shift toward curable stages, early PCa detection remains limited in several ways. First, a PSA cut-off level such as 4.0 ng/ml for biopsy indication is characterized by a limited PCa specificity due to the effect on PSA of other underlying prostatic diseases such as inflammation or benign prostatic hyperplasia. Therefore, PSA represents only a surrogate marker of PCa. Additionally, as clearly demonstrated in the Prostate Cancer Prevention Trial (PCPT), instead of cut-off levels, PSA values represent a continuum of PCa risk. Thus single PSA measurements are unable to rule out the presence of disease [4]. In fact, it may be anticipated that the principal early detection driving force, that is, PSA, will weaken its association to PCa because a significant proportion of men who present for prostatic evaluation already have PSA values below specific cut-off levels such as 4.0 ng/ml. Consequently, the benefits of PSA-driven early detection, especially in the light of the most recent data from the European and American PCa screening trials, must be carefully balanced and may also be perceived controversially [1], [2].
Second, except for palpable lesions, clinical symptoms on which a urologist may identify early disease are practically absent [5]. Third, despite substantial technological progress, neither visualization nor molecular characterization is currently advanced enough to indicate reliably the presence or absence of underlying malignant disease [6].
Therefore, the significant research effort based on established clinical prebiopsy risk factors such as age, PSA, percentage of free prostate-specific antigen (%fPSA), digital rectal examination (DRE), prostate volume, and the consideration of novel markers such as urinary prostate cancer antigen 3 (PCA3) [7], [8], [9], [10], [11], [12] has resulted in multifactorial statistical models to individualize biopsy indication and thus to subject only those men with the highest risk to further prostatic evaluation. In addition to identifying those individuals at high risk for harboring PCa, the combined proper use of prebiopsy clinical risk predictors reduces the proportion of unnecessary biopsies, biopsy-related side effects, and patient anxiety [8], [13].
Prostate biopsy represents a “hot-spot area” on different levels [14]. For example, the determination of the optimal number of cores and prostate sampling sites stratified according to biopsy session, the systematic versus targeted prostate biopsy approach, the need to quantify certain histologic patterns such as high-grade prostatic intraepithelial neoplasia (HGPIN), the optimal pathologic processing of the biopsy cores, and the expertise-dependent pathologic interpretation are controversial.
Beyond these ongoing debates, it is important to note that “typical” clinical biopsy studies carry a so-called verification bias that makes it difficult to truly assess, for example, the influence of different biopsy schemes due to the unknown proportion of “falsely biopsy-negative” men [15]. Consequently, identification of a prostate biopsy gold standard is almost impossible.
Taken together, these different activities potentially add to the current uncertainty of how to perform and how to interpret a prostatic biopsy. To address this significant and competitive interdisciplinary field, this review considers the current clinical evidence investigating risk factors including novel markers, performance of prostate biopsy in different clinical settings, and pathologic interpretation of prostate biopsy.
Section snippets
Evidence acquisition
A systematic review of the literature was performed in December 2009 using the Medline database. The Medline search used a complex search strategy including both Medical Subject Heading (MeSH) search terms and free-text protocols. Specifically, the MeSH search was conducted by combining the following terms retrieved from the MeSH browser provided by Medline: prostate biopsy, prostate cancer, detection, transrectal ultrasound (TRUS), nomogram, and diagnosis. Subsequently, the search results were
Risk stratification models as clinical decision aids for biopsy indication
Risk estimation, patient counseling, and decision making are based on clinical judgment. The major limitation is that clinical judgment is biased at all of these stages of patient management [16], [17], [18], [19]. Specifically, PCa risk depends on multiple clinical risk factors. In fact, it is difficult to adequately consider the multitude of these clinical variables followed by weighing each factor’s relative importance and to formulate a PCa risk estimation [20], [21], [22]. Therefore,
Conclusions
Review of the most relevant biopsy studies reveals that current questions such as how many cores to take at which biopsy session or where to direct biopsy cores have attracted the attention of urologists for the past 20 yr. Currently, a minimum of 10 but not >18 systematic cores at initial biopsy are recommended, with 14–18 cores in glands ≥50 cm3. Biopsies should be directed laterally, and TZ cores are not recommended in the initial biopsy setting. Further biopsy sets either as an extended
References (128)
- et al.
EAU guidelines on prostate cancer
Eur Urol
(2008) - et al.
Clinical utility of the PCA3 urine assay in European men scheduled for repeat biopsy
Eur Urol
(2008) - et al.
Prostate cancer gene 3 (PCA3): development and internal validation of a novel biopsy nomogram
Eur Urol
(2009) - et al.
PCA3: a molecular urine assay for predicting prostate biopsy outcome
J Urol
(2008) - et al.
PCA3 molecular urine assay for prostate cancer in men undergoing repeat biopsy
Urology
(2007) - et al.
Development and external validation of an extended 10-core biopsy nomogram
Eur Urol
(2007) - et al.
Extended and saturation prostatic biopsy in the diagnosis and characterisation of prostate cancer: a critical analysis of the literature
Eur Urol
(2007) Expert systems in medicine
- et al.
Prostate cancer nomograms: an update
Eur Urol
(2006) - et al.
Development, validation, and head-to-head comparison of logistic regression-based nomograms and artificial neural network models predicting prostate cancer on initial extended biopsy
Eur Urol
(2008)
Development and external validation of an extended repeat biopsy nomogram
J Urol
Initial biopsy outcome prediction—head-to-head comparison of a logistic regression-based nomogram versus artificial neural network
Eur Urol
Prostate cancer: are we over-diagnosing—or under-thinking?
Eur Urol
The ultimate prostate cancer biopsy decision support tool
Eur Urol
The influence of prostate size on cancer detection
Urology
Development and external validation of an extended 10-core biopsy nomogram
Eur Urol
Development and external validation of an extended repeat biopsy nomogram
J Urol
Prostate volume and adverse prostate cancer features: fact not artifact
Eur J Cancer
Random systematic versus directed ultrasound guided transrectal core biopsies of the prostate
J Urol
Use of extended pattern technique for initial prostate biopsy
J Urol
Optimal combinations of systematic sextant and laterally directed biopsies for the detection of prostate cancer
J Urol
Extended 21-sample needle biopsy protocol for diagnosis of prostate cancer in 1000 consecutive patients
Eur Urol
The 20-core prostate biopsy protocol—a new gold standard?
J Urol
Initial extended transrectal prostate biopsy—are more prostate cancers detected with 18 cores than with 12 cores?
J Urol
Biopsy schemes with the fewest cores for detecting 95% of the prostate cancers detected by a 24-core biopsy
Eur Urol
Diagnostic value of systematic biopsy methods in the investigation of prostate cancer: a systematic review
J Urol
Prospective evaluation of a 21-sample needle biopsy procedure designed to improve the prostate cancer detection rate
Urology
The potential impact of prostate volume in the planning of optimal number of cores in the systematic transperineal prostate biopsy
Eur Urol
Improved prostate cancer detection using systematic 14-core biopsy for large prostate glands with normal digital rectal examination findings
Urology
Extensive biopsy protocol improves the detection rate of prostate cancer
J Urol
Making the most out of six systematic sextant biopsies
Urology
Six additional systematic lateral cores enhance sextant biopsy prediction of pathological features at radical prostatectomy
J Urol
Extended peripheral zone biopsy schemes increase cancer detection rates and minimize variance in prostate specific antigen and age related cancer rates: results of a community multi-practice study
J Urol
Anterior distribution of stage T1c nonpalpable tumors in radical prostatectomy specimens
Urology
Parasagittal biopsies add minimal information in repeat saturation prostate biopsy
Urology
Results of the 5 region prostate biopsy method: the repeat biopsy population
J Urol
Prospective evaluation of prostate cancer detected on biopsies 1, 2, 3 and 4: when should we stop?
J Urol
Diagnostic yield of repeated transrectal ultrasound-guided biopsies stratified by specific histopathologic diagnoses and prostate specific antigen levels
Urology
Serial prostatic biopsies in men with persistently elevated serum prostate specific antigen values
J Urol
Repeat screening for prostate cancer after 1-year followup in 984 biopsied men: clinical and pathological features of detected cancer
J Urol
Repeat ultrasound guided prostate needle biopsy: use of free-to-total prostate specific antigen ratio in predicting prostatic carcinoma
J Urol
Extensive repeat transrectal ultrasound guided prostate biopsy in patients with previous benign sextant biopsies
J Urol
Impact of prior biopsy scheme on pathologic features of cancers detected on repeat biopsies
Urol Oncol
Predictors of prostate cancer after initial negative systematic 12 core biopsy
J Urol
Prostate cancer detection rate in patients with repeated extended 21-sample needle biopsy
Eur Urol
Systematic prostate biopsies are more and more often becoming saturation biopsies
Eur Urol
Are transition zone biopsies still necessary to improve prostate cancer detection? Results from the Tyrol screening project
Eur Urol
Improved prostate cancer detection with anterior apical prostate biopsies
Urol Oncol
Prostate needle biopsies containing prostatic intraepithelial neoplasia or atypical foci suspicious for carcinoma: implications for patient care
J Urol
Prostatic intraepithelial neoplasia and the origins of prostatic carcinoma
Pathol Res Pract
Cited by (96)
Multiparametric MRI: An Opportunity for Focal Therapy of Prostate Cancer
2018, Seminars in RoentgenologyDoes Core Length Taken per cc of Prostate Volume in Prostate Biopsy Affect the Diagnosis of Prostate Cancer?
2016, Clinical Genitourinary CancerCitation Excerpt :Although prostate biopsy under transrectal ultrasound guidance is the gold standard in diagnosis of prostate cancer, there is still ongoing controversy as to what the core number and core length taken in the biopsy should be. Rates of determination of prostate cancer in the first biopsy have been reported to vary between 25% and 45%.1-6 Following the 1989 studies by Hodge et al related to transrectal ultrasound-guided sextant prostate biopsy, the random systemic 6-core prostate biopsy started to become extremely popular and provided progress in the diagnosis of prostate cancer.6