Extended 21-sample needle biopsy protocol for diagnosis of prostate cancer in 1000 consecutive patients

OBJECTIVE: To prospectively evaluate the diagnostic yield of a 21-sample ultrasound-guided needle biopsy protocol as the initial diagnostic strategy for detection of prostate cancer. MATERIALS AND METHODS: Between December 2001 and October 2005, 1000 consecutive patients underwent 21-sample needle biopsies under local anesthesia, comprising sextant biopsies, 3 additional posterolateral biopsies in each peripheral zone, 3 biopsies in each transition zone (TZ), and 3 biopsies in the midline peripheral zone. Each prostate core was numbered and analyzed separately. The patients were divided into subgroups according to the result of digital rectal examination (DRE), serum prostate-specific antigen (PSA), and prostate volume. We evaluated the cancer detection rate overall and in each subgroup. We compared the results of our biopsy protocol to those from 6-, 12-, and 18-core biopsy protocols by analyzing only those cores from our protocol that would correspond to these biopsy schemes. RESULTS: Cancer detection rates using 6 biopsy samples (sextant biopsies only), 12 samples (sextant plus lateral biopsies), 18 samples (sextant, lateral, and TZ biopsies), and 21 samples (sextant, lateral, TZ, plus midline biopsies) were 31.7%, 38.7%, 41.5%, and 42.5%, respectively. The 12-sample procedure improved the cancer detection rate by 22% compared with the 6-sample procedure (p=0.0001). The improvement in the diagnostic yield was most marked in patients with a prostate volume > or =55 ml (36.9%), in patients with normal DRE (26.6%), and in patients with PSA<4 (37.5%). The addition of TZ biopsies to a 12-biopsy scheme increased the diagnostic yield by 7.2% overall (p=0.023). Only 10 of 425 (2.3%) patients were diagnosed on the sole basis of midline biopsies. CONCLUSIONS: Patients with suspected localized prostate cancer should be offered at least 12 biopsies in the peripheral zone and far lateral peripheral zone (statistically significant). TZ biopsies have to be considered, because these biopsies improve the diagnostic yield. For patients with abnormal DRE and/or PSA> or =20 ng/ml, the 6-biopsy scheme seems sufficient (statistically), but 6 far lateral peripheral zone biopsies as well as the TZ biopsies add little incremental value (not significant). Evidence does not support the use of routine midline peripheral zone needle biopsies in the initial biopsy to enhance the detection of prostate cancer.     

Transrectal ultrasound guided biopsy of the prostate: random sextant versus biopsies of sono-morphologically suspicious lesions

Transrectal ultrasound (TRUS) guided multiple systematic random biopsies are presently the method of choice for determining the presence or absence of prostate cancer. TRUS image information is only used to guide the biopsy needle into the prostate, but not to localize and target cancerous lesions. Our aim in this study was to evaluated the possible predictive value of tumor suspicious endosonographic lesions of the prostate for prostate biopsies. We prospectively compared six systematic biopsies with lesion guided biopsies in a consecutive series of 217 patients. All patients had a prostate specific antigen (PSA) level of >4 ng/ml without a history of prostate disease. In a subgroup of 145 men with sonomorphologic lesions suggestive for prostate cancer (hypoechoic areas or asymmetries predominantly in the peripheral zone), lesion-guided biopsies were taken in addition to the systematic biopsies. We evaluated the number of tumors which were diagnosed or missed by both of the biopsy strategies. Of the 217 evaluated patients, 64 (29%) had histology confirmed cancer. Four patients with negative sextant biopsies had a positive TRUS guided biopsy. Out of 145 patients with a normal TRUS, three were cancer positive by sextant biopsy. A total of 1,387 individual biopsy cores were evaluated. Of the 1,304 systematic biopsy cores, 182 (14%) were positive and 1,122 (86%) negative. Of the 329 TRUS lesion guided biopsy cores 139 (42%) were positive and 190 (58%) negative. Patients with tumor suggestive TRUS lesions have a considerably higher risk of being diagnosed with prostate cancer compared to patients without such lesions. Both systematic sextant and TRUS lesion guided biopsies missed detectable prostate cancer in a minority of patients. Taking the endosonographic morphology of the prostate gland into consideration for biopsy strategies may improve the quality of the biopsy and avoid unnecessary invasive procedures in selected cases.     

OPTIMIZATION OF PROSTATE BIOPSY STRATEGY USING COMPUTER BASED ANALYSIS

Purpose

We evaluated and optimized the detection of cancer by prostate biopsies. We developed a stochastic computer simulation model of ultrasound guided biopsies using mathematically reconstructed radical prostatectomy specimens. Use of this technique allows rapid evaluation of a variety of factors for their effect on prostate biopsy results. We used this model analyze the effectiveness of sextant biopsies, which have been widely adopted in clinical practice. We also analyzed other biopsy schemes.

Materials and Methods

A total of 607 tumor foci from 180 serially sectioned whole mount radical prostatectomy specimens was mapped and digitized. The cancers had been clinically diagnosed by a variety of biopsy strategies. Simulated parasagittal sextant biopsies were performed for each case. Forty simulation runs (each consisting of a set of 6 biopsies) were performed for each prostate, with realistic random variations in sextant biopsy localization programmed in each run. Cancer detection by biopsy was considered reliable if 90% of the stimulation runs for each prostate were positive for cancer. A summary algorithm was used to map the tumor foci.

Results

Simulation of sextant biopsies demonstrated reliably detected cancer in only 107 of 147 patients (73%) in whom total tumor volume was greater than 0.5 cc. There was little correlation between total length of cancer in biopsy cores and tumor volume. Change of biopsy angle from 30 to 45 degrees did not result in significantly increased detection rates. Similarly, placing all biopsies more laterally did not increase overall detection rates. When we mapped tumor foci from the 40 cases in which sextant biopsies did not reliably detect tumor, we found that the foci were distributed in areas not biopsied by the sextant method, that is the transition zone, midline peripheral zone and inferior portion of the anterior horn of the peripheral zone. A 10-core biopsy scheme incorporating these areas as well as the posterolateral prostate reliably detected cancer in 141 of 147 patients (96%) with total tumor volumes greater than 0.5 cc.

Conclusions

Prostate cancer of significant volume can be present in areas not sampled by standard sextant biopsies. Biopsies of the transition zone, midline peripheral zone and inferior portion of the anterior horn of the peripheral zone should be considered for re-biopsy strategy after negative sextant biopsies. Sampling of these additional areas also can be incorporated in an initial biopsy scheme to increase overall initial rates of detection of prostate cancer.     

Prospective comparison of computerized tomography and excretory urography in the initial evaluation of asymptomatic microhematuria

PURPOSE: We examine the potential impact of extended systematic biopsy schemes in patients with a prior negative prostate biopsy. MATERIALS AND METHODS: Between January 1999 and March 2001, 185 patients with a prior negative prostate needle biopsy underwent repeat biopsy. Systematic 10 core biopsies (sextant, lateral mid gland and lateral base) were performed in all patients. A subset of 111 patients underwent 6 additional biopsies directed anteriorly. All biopsy results were reviewed by a single pathologist. The overall and unique cancer detection rates were calculated for each biopsy site. McNemar's test was then used to compare the yield of various simulated biopsy schemes to define the optimal biopsy regimen. RESULTS: Overall, 67 of 185 patients (36%) were found to have cancer on repeat biopsy. The highest detection rate was found for the apex, lateral base and lateral mid sites. The mid lobar base site consistently yielded the lowest detection rate. These results were mirrored in the unique cancer detection rate calculations. The traditional sextant scheme detected only 73% of tumors. Using a lateral sextant scheme (apex, lateral mid gland and lateral base), the detection rate increased to 85% (p = 0.15). An 8 core biopsy scheme (apex, mid gland, lateral mid gland and lateral base) increased the detection rate to 95%. However, there was no significant increase in cancer detection rate when the 8 core scheme was compared to the 10 core scheme. The 6 anteriorly directed biopsies uniquely detected only 2 cancers. CONCLUSIONS: We recommend that patients with a prior negative prostate biopsy who are undergoing repeat biopsy receive at least an 8 core biopsy scheme weighted toward the lateral aspect of the prostate.     

Lateral biopsies added to the traditional sextant prostate biopsy pattern increases the detection rate of prostate cancer

Urologists routinely use the systematic sextant needle biopsy technique to detect prostate cancer. However, recent evidence suggests that this technique has a significant sampling error and data based upon whole-mounted step-sectioned radical prostatectomy specimens using a three-dimensional computer-assisted prostate biopsy simulator suggests that an increased detection rate is possible using laterally placed biopsies. The simulated 10-core biopsy pattern (traditional sextant biopsy cores and four laterally placed biopsies in the right and left apex and mid portion of the prostate gland) was shown to be superior to the traditional sextant biopsy. The objective of this pilot study was to confirm the higher prostate cancer detection rate obtained using the 10-core biopsy pattern in patients. We reviewed data on 35 consecutive patients with a pathologic diagnosis of prostate cancer biopsied by a single urologist using the 10-core biopsy pattern. The frequency of positive biopsy was determined for each core. Additionally, the sextant and 10-core prostate biopsy patterns were compared with respect to prostate cancer detection rate. Of the 35 patients diagnosed with prostate cancer, 54.3%(19/35) were diagnosed by the sextant biopsy only. The 10-core pattern resulted in an additional 45.7%(16/35) of patients being diagnosed solely with the laterally placed biopsies. The laterally placed biopsies had the highest frequency of positive biopsies when compared to the sextant cores. In conclusion, biopsy protocols that use laterally placed biopsies based upon a five region anatomical model are superior to the routinely used sextant prostate biopsy pattern. Prostate Cancer and Prostatic Diseases (2000) 3, 43-46     

Three-dimensional computer-simulated prostate models: lateral prostate biopsies increase the detection rate of prostate cancer

OBJECTIVES: Urologists routinely use the systematic sextant needle biopsy technique to detect prostate cancer. However, recent evidence suggests that this technique has a significant sampling error. We developed a novel three-dimensional (3D) computer-assisted prostate biopsy simulator based on whole-mounted step-sectioned radical prostatectomy specimens to compare the diagnostic accuracy of various prostate needle biopsy protocols. METHODS: We obtained digital images of 201 step-sectioned whole-mounted radical prostatectomy specimens. 3D computer simulation software was developed to accurately depict the anatomy of the prostate and all individual tumor foci. Additional peripheral devices were incorporated into the system to perform interactive prostate biopsies. We obtained 18 biopsies of each prostate model to determine the detection rates of various biopsy protocols. RESULTS: The 10- and 12-pattern biopsy protocols had a 99.0% detection rate; the traditional sextant biopsy protocol rate was only 72.6%. The 5-region biopsy protocol had a 90.5% detection rate and the 14-pattern, which includes all the biopsies used in the patterns above, only added 1 additional positive case (99.5%). Transitional zone and seminal vesicle biopsies did not result in a significantly increased detection rate when added to the patterns above. Only one positive model was obtained when the transitional zone biopsies were added. The lateral sextant pattern had a detection rate of 95.5%, and the 4-pattern lateral biopsy protocol had a 93.5% detection rate. CONCLUSIONS: Our results suggest that all the biopsy protocols that use laterally placed biopsies based on the 5-region anatomic model are superior to the routinely used sextant prostate biopsy pattern. Lateral biopsies in the mid and apical zones of the gland are the most important.     

Comparison of prostate biopsy schemes by computer simulation

OBJECTIVES: To compare the ability of different biopsy schemes to detect cancer and predict tumor volume using our previously described prostate biopsy simulation system. In addition, we used the simulation system to evaluate the optimal location of transition zone biopsies. METHODS: Digital reconstructions of 180 radical prostatectomy specimens were used. Forty simulations were performed on each prostate for 10 biopsy schemes, including a previously reported five-region peripheral zone biopsy pattern and a new 11-core multisite-directed scheme consisting of sextant, two transition zone, one midline, and two anterior horn biopsies. For simulation of the transition zone biopsies, paired near-midline biopsies were simulated, with needle insertion points from the apex to the base of the prostate and with needle advances of 1 to 4 cm before firing. A total of 1,180,800 individual biopsy tracks were simulated. RESULTS: The 11-core multisite-directed biopsy scheme had the highest detection rate for cancers greater than 0.5 cc. This scheme reliably detected cancer in 94% (138 of 147) of the cases. These results were significantly better than those of the sextant biopsy scheme (P <0.001) and the five-region 18-core peripheral zone scheme (P = 0.03). Compared with other schemes, there were increases in small-volume (0.5 cc or less) cancer detection by both the 11-core multisite-directed and five-region schemes, but they were not statistically significant. The multisite and the sextant plus four transition zone biopsy schemes had the best correlation of mean total core cancer length with total cancer volume. In the simulation of the transition zone biopsies, the highest detection rate was observed when the biopsies were initiated at the most apical section and inserted for a depth of 3 cm before firing. CONCLUSIONS: Our simulation results suggest that the detection rate of prostate biopsies is not related solely to the number of cores taken. Core placement (the regions of the prostate from which samples are taken) is also important. The 11-core multisite-directed biopsy scheme performed the best, with improved cancer detection rates and tumor volume correlation over other schemes. On the basis of our simulations, this scheme has been chosen for clinical evaluation.     

PROSTATE CANCER DIAGNOSIS USING A SATURATION NEEDLE BIOPSY TECHNIQUE AFTER PREVIOUS NEGATIVE SEXTANT BIOPSIES

PURPOSE: We hypothesized that markedly increasing the number of cores obtained during prostate needle biopsy may improve the cancer detection rate in men with persistent indications for repeat biopsy. MATERIALS AND METHODS: We performed saturation ultrasound guided transrectal prostate needle biopsy in 224 men under anesthesia in an outpatient surgical setting in whom previous negative biopsies had been performed in the office. The mean number of previous sextant biopsy sessions plus or minus standard deviation before saturation biopsy was 1.8 (range 1 to 7). A mean of 23 saturation biopsy cores (range 14 to 45) were distributed throughout the whole prostate, including the peripheral, medial and anterior regions. Indications for repeat biopsy were persistent elevated serum prostate specific antigen (PSA) in 108 cases, persistent elevated PSA and abnormal rectal examination in 27, persistent abnormal rectal examination in 4, high grade prostatic intraepithelial neoplasia in the previous biopsy in 64 and atypia in the previous biopsy in 21. RESULTS: Cancer was detected in 77 of 224 patients (34%). The number of previous negative sextant biopsies was not predictive of subsequent cancer detection by saturation biopsy. Median PSA was 8.7 ng./ml. and median PSA velocity was 0.63 ng./ml. yearly. Of the 77 patients in whom cancer was detected radical prostatectomy was performed in 52. Pathological stage was pT2 in 48 patients and pT3 in 4, while Gleason score was 4 to 5, 6 to 7 and 8 in 5, 46 and 1, respectively. At prostatectomy median cancer volume was 1.04 cc and 85.7% of removed tumors were clinically significant, assuming a 3-year doubling time. The overall complication rate for saturation needle biopsy was 12% and hematuria requiring hospital admission was the most common event. CONCLUSIONS: Saturation needle biopsy of the prostate is a useful diagnostic technique in men at risk for prostate cancer with previous negative office biopsies. This technique allows adequate sampling of the whole prostate gland and has a detection rate of 34% in this cohort of patients.     

Prostate biopsy outcome using 29 mm cutting length

OBJECTIVES: The aim of the study was to compare the prostate biopsy outcome by using either standard or extended cutting length of the needles. MATERIAL AND METHODS: A total of 74 consecutive prostates from radical prostatectomy were used. Two sextant biopsies were performed ex vivo. We developed a precise simulation of a transrectal biopsy procedure using ultrasound for guiding the needle. In the first set of biopsies an 18-gauge tru cut needle with 19 mm cutting length, powered by a automatic biopsy gun was used. In the second set a single use gun with an 18-gauge end-cutting needle and 29 mm cutting length was used. RESULTS: In the set of sextant biopsies using 19 mm cutting length 49 (66%) carcinomas were found. In the set of sextant biopsies using 29 mm cutting length 58 (78%) of the tumors were detected. 24 (32%) prostates showed tumor in the transition zones, but there was no transition-zone-only cancer in this study. Nevertheless taking longer cores led to an improvement in prostate cancer detection of 18%. CONCLUSIONS: In this ex vivo setting the use of 29 mm cutting length for prostate biopsy led to an significant improvement in cancer detection. As we found the end-cutting needle not suitable for use in the patient, these results support the idea to develop a longer tru cut needle and corresponding gun for further clinical investigations.     

经直肠超声引导穿刺活检诊断早期前列腺癌漏诊原因的分析

目的:分析经直肠超声(TRUS)引导下穿刺活检诊断前列腺癌的漏诊原因,减少漏诊率,提高诊断率。方法:80例疑似前列腺癌的良性前列腺增生(BPH)患者行TRUS引导下穿刺活检,结果均为阴性,均行前列腺电切术(TURP),术后标本行病理检查。结果:25例术后病理报告为前列腺癌,漏诊率31.25%(25/80)。其中10例行经会阴前列腺癌根治术、8例行手术去势、7例行药物去势。结论:TRUS引导穿刺活检诊断前列腺癌存在一定的漏诊,多次或多点穿刺活检可以减少漏诊率。     

Value of Systematic Transition Zone Biopsy in the Detection of Prostate Cancer

Background:
We evaluated routine transition zone biopsies for the detection of prostate cancer.
Methods:
Systematic sextant transrectal biopsies, including 2 systematic transition zone biopsies (sextant biopsy group), were performed on 196 consecutive patients. Biopsies were based on indications from digital rectal examination and/or a serum PSA level greater than 4.0 ng/ml. During the same period, 21 patients with persistently elevated PSA levels and earlier negative systematic biopsies also had the sextant biopsy (re-biopsy group). The sextant biopsy group was compared with 1 24 cases in our previous cancer detection program who had systematic quadrant biopsies targeted to the peripheral zone (quadrant biopsy group).
Results:
Between the sextant and quadrant biopsy groups, the difference in rate of cancer detection was not significant statistically. Of the sextant biopsy group, 64 (33%) demonstrated malignancy, including 9 (4.6%) with cancer found exclusively in the peripheral zone and 55 (28%) both in the peripheral and transition zones. No cancer was found exclusively in the transition zone. Of the re-biopsy group, all 4 cancers (19%) were detected in the transition zone, 2 of them exclusively in the transition zone.
Conclusion:
Routine transition zone biopsies did not increase the detection rate of prostate cancer. Systematic transition zone biopsies proved useful to the patients with persistently elevated PSA values and negative results in previous systematic peripheral zone biopsies.     

Additional Midline Biopsies of the Peripheral Zone Associated with the First Endorectal Standard Sextant Pattern Improves the Accuracy of Prostate Cancer Detection in Japanese Patients

Objectives

This study was designed to estimate the improved accuracy of prostate cancer (PCa) detection resulting from additional midline biopsies of the peripheral zone in first standard biopsy.

Patients and Methods

Patients were classified into 3 groups: 402 cases of sextant biopsies (1995–2002), 488 cases of 8-core biopsies with 2 additional midline biopsies (2003–2006), and 391 cases of 10-core biopsies with 4 additional midline biopsies (2007–2012). The positive rate of each number of biopsies and changes in positive rates associated with prostate specific antigen (PSA) ranges were estimated.

Results

The positive rate of core biopsy significantly improved with increasing numbers of core biopsies (30.1% for sextant, 43.4% for 8-core biopsies, and 53.1% for 10-core biopsies). The accuracy of biopsies for each PSA range also significantly improved (22.3% for sextant, 30.0% for 8-core biopsies, and 43.2% for 10-core biopsies in the PSA gray zone [4.01–10 ng/ml]; and 26.5% for sextant, 52.9% for 8-core biopsies, and 71.8% for 10-core biopsies in the intermediate PSA range [10.1–20 ng/ml]). In the 208 cases with positive results using the 10-core biopsy method, the distribution of Gleason scores did not differ between the sextant only group and the midline site only group.

Conclusions

Additional midline biopsy was associated with improved accuracy of positive core biopsies in Japanese patients with a PSA range of 4.01–20 ng/ml.© 2015 S. Karger AG, BaselKey Words: Additional midline, Diagnosis accuracy, Prostate cancer, First endorectal biopsy, Systematic biopsy     

Comparison of ultrasound-guided biopsies and prostatectomy specimens: predictive accuracy of Gleason score and tumor site

OBJECTIVE: To critically evaluate the accuracy of sextant biopsies in predicting Gleason score and the site of tumor location in patients with clinically localized prostate cancer treated by radical perineal prostatectomy. METHODS: The case records of 289 patients with clinically localized prostate cancer who underwent radical perineal prostatectomy were reviewed, comparing the Gleason score and tumor site location as determined by sextant ultrasound-guided core biopsies with the Gleason score and tumor distribution within the surgical specimens. The prostatectomy specimens were further characterized by extent of disease as organ-confined, specimen-confined or margin-positive. RESULTS: The Gleason score was identical in 126 (43.5%) patients. An upgrading in the surgical specimen occurred in 118 (40.8%) cases, a downgrading in 43 (14.8%). Overall, 193 (66.7%) patients had a unilateral positive biopsy, while 96 (33.2%) patients had bilateral positive biopsies. Sixty-four (33.1%) patients with a unilateral positive biopsy had cancer confined to one side of the gland, while 127 (65.8%) showed bilateral disease; 142 (73.5%) patients had organ-confined tumors versus 51 (26.4%) patients with capsular penetration. In the 96 patients with bilateral positive biopsies, 64 (66.6%) patients had intracapsular cancer versus 32 (33.3%) patients with either specimen-confined or margin-positive disease. The overall rate of positive margins was 14%. Fifty-one (61.4%) of the 83 patients with non-organ-confined disease had posterolateral capsular penetration in the region of the superior pedicle of the neurovascular bundle, while 28 (33.7%) patients had apical capsular penetration, in the region of the inferior neurovascular pedicle. CONCLUSIONS: The ability of sextant ultrasound-guided biopsies to estimate the pathological grading is satisfactory: when we consider a difference of +/- 1 in the final Gleason score, the overall correlation is 80%. In 66% of the cases, sextant biopsies predicted unilateral disease when bilateral disease existed. A unilateral positive biopsy does not predict unilateral disease.     

Is systematic sextant biopsy suitable for the detection of clinically significant prostate cancer?

BACKGROUND: The optimal extent of the prostate biopsy remains controversial. There is a need to avoid detection of insignificant cancer but not to miss significant and curable tumors. In alternative treatments of prostate cancer, repeated sextant biopsies are used to estimate the response. The aim of this study was to investigate the reliability of a repeated systematic sextant biopsy as the standard biopsy technique in patients with significant tumors which are being considered for curative treatment. METHODS: Systematic sextant biopsy was performed in vitro in 92 radical prostatectomy specimens. Of these patients, 81 (88.0%) had palpable lesions. RESULTS: Of the 92 investigated patients, 70 (76.1%) had potentially curable pT2-3pN0 prostate cancers. In these patients, the cancer was detected only in 72.9% of cases by a repeated in vitro biopsy. In the pT2 tumors, there was a detection rate of only 66.7%. CONCLUSIONS: This study underlines the fact that a considerable number of significant and potentially curable tumors remain undetected by the conventional sextant biopsy. A negative sextant biopsy does not rule out significant prostate cancer.     

Comparison of systematic sextant and lesion directed biopsies in prostate cancer detection

This study was designed to determine the value of performing separate lesion directed biopsies in addition to systematic random sextant biopsies for the detection, grading, and assessment of bilaterality of prostate cancer. A prospective study of 82 consecutive patients who had peripheral zone hypoechoic regions visualized on transrectal ultrasound was performed. All patients had either an abnormal prostate-specific antigen or an abnormal digital rectal examination and underwent random systematic and lesion directed biopsies. Cancer detection, laterality, and histologic grade of lesion directed biopsies were compared with those from systematic random biopsies. Prostate cancer was detected in 35 (40%) of 82 patients who had a hypoechoic lesion visualized. Three (9%) cancers would have been missed if only systematic biopsies had been performed, while nine (26%) cancers would have been missed if only lesion directed biopsies had been performed. In all but one patient, the Gleason score of the lesion directed biopsy was equal to or within one grade of the highest Gleason score determined from systematic biopsy. Systematic random biopsies detected cancer on the opposite side of a positive lesion directed biopsy in 48% of patients. In no case did a lesion directed biopsy add to the detection of bilateral disease. In conclusion, lesion directed biopsies increase the detection of prostate cancer when performed in addition to systematic random sextant biopsies. However, lesion directed biopsies alone would result in a substantial miss rate of prostate cancer. They do not add to the determination of bilateral disease, nor do they add to the pathologic grading of the detected cancer.     

Prostate biopsy protocols: 3D visualization-based evaluation and clinical correlation.

OBJECTIVES: Systematic needle core biopsy is commonly used for the diagnosis of prostate cancer by urologists worldwide. As accurate and early diagnosis will result in more and better options for treatment, it is critical that the best possible protocols for biopsy be used clinically. In this study, we develop three-dimensional (3D) modeling and simulation technologies to evaluate most of the biopsy protocols in current clinical use, and correlate the results with those from clinical cases. MATERIALS AND METHODS: Using deformable modeling techniques, 3D computerized prostate surface models were reconstructed from step-sectioned, whole-mounted radical prostatectomy specimens with localized prostate cancer. A 3D computer simulation system was developed to accurately depict the anatomy of the prostate and all individual tumor foci. A user-friendly interface was developed in the system so that a physician can easily and interactively use it for prostate needle core biopsy. A total of 281 prostate models were reconstructed, and 18 biopsies were performed by a urologist on each model to determine the detection rates of seven different biopsy protocols. Clinical biopsies from 35 patient cases were also reviewed and correlated with the simulation results. RESULTS: The most commonly used sextant biopsy had only a 71.5% detection rate, while rates for the 10-pattern and 12-pattern protocols were much higher (96.4% and 97.2%, respectively). Even the lateral 4-pattern protocol performed better than the sextant protocol, with a detection rate of 89.3%. The lateral sextant biopsy protocol (using sites similar to, but more lateral than, those in the sextant protocol) achieved a rate of 92.5%. Although the rate of the 14-pattern biopsy was a little higher (97.5%), it used four more biopsies to achieve this increase, which, according to McNemar's test, is not statistically significant when compared to results with the 10-pattern protocol. The 5-region protocol, which uses 12 biopsies, had a detection rate of 89.7%. Transition zone and seminal vesicle biopsies did not result in a significantly increased detection rate when added to the patterns above. The clinical correlation also confirmed that the 10-pattern protocol was significantly superior to the traditional sextant biopsy pattern. CONCLUSIONS: The 10-pattern biopsy protocol was the most optimized among all the protocols evaluated. This protocol supplemented the sextant biopsy protocol with four more lateral biopsies in the mid and apical sites on both sides.     

Detection rate of histologically insignificant prostate cancer with systematic sextant biopsies and fine needle aspiration cytology

PURPOSE: We evaluate the detection rate of insignificant prostate cancer and the rate of significant prostate cancer overlooked in the results of systematic sextant biopsy and fine needle aspiration biopsy of the prostate of asymptomatic men with serum prostate specific antigen concentrations less than 4.0 ng./ml. MATERIALS AND METHODS: We analyzed specimens from 133 consecutive patients with a mean age of 60 years undergoing cystoprostatectomy for bladder cancer. Six systematic biopsy specimens and 2 fine needle aspiration cytology samples were taken from the prostate immediately after cystoprostatectomy. The specimens were step sectioned and examined for prostate cancer. Insignificant prostate cancer was defined as any cancer with an aggregate volume 0.5 cm.3 or less. RESULTS: Incidental prostate cancer was found in 58 of the 133 patients (44%). Tumor volume was 0.5 cm.3 or less in 47 cases. Sextant biopsy detected 7 cancers, including 4 of 47 (9%) that were insignificant and 3 of 11 (27%) that were significant. Fine needle aspiration cytology also detected 7 cancers, including 3 (6%) and 4 (36%) that were insignificant and significant, respectively. CONCLUSIONS: Systematic sextant biopsy and fine needle aspiration cytology each diagnose prostate cancer in about 5% of asymptomatic men who have normal digital rectal examination and serum prostate specific antigen less than 4.0 ng./ml. However, many of the cancers thus detected are insignificant and most of the significant cancers are missed. Therefore, routine screening of such patients with sextant biopsy or aspiration cytology does not appear to be justified.     

Improving prostate cancer detection with an extended-core transrectal ultrasonography-guided prostate biopsy protocol

OBJECTIVE: To investigate whether taking two transition zone (TZ) and four lateral peripheral zone (PZ) biopsies in addition to routine parasaggital sextant biopsies would improve detection rates in men with suspected prostate cancer. PATIENTS AND METHODS: The study included 493 consecutive men (mean age 68.7 years, sd 8.2) with elevated serum prostate-specific antigen (PSA) levels and/or abnormal findings on a digital rectal examination who underwent transrectal ultrasonography-guided prostate biopsy. In addition to sextant biopsies, six further biopsies were obtained, two from the TZ (mid-gland) and four from the lateral PZ (base and mid-gland). Pathological findings for the additional biopsies were compared with those of the sextant regions. RESULTS: Prostatic adenocarcinoma was diagnosed in 164 of the 493 (33%) men biopsied. Men with cancer were older, had smaller prostates and higher median PSA levels than men with negative biopsies. Sextant biopsies were positive for cancer in 133 of 164 (81%) men. All three sets of biopsies were positive in 53 (32%) cases. In 50 (30%) men both the sextant and lateral PZ biopsies were positive, while in six (4%) men, both sextant and TZ biopsies were positive. Thirty-one (19%) tumours were not detected by sextant biopsies, 10 (6%) where the lateral PZ biopsies alone were positive, 17 (10%) where the TZ biopsies alone were positive and four (3%) where both the TZ and lateral PZ together were positive. There were no differences in median PSA concentration, total prostate volume or TZ volume between men with an isolated TZ cancer and men with cancer elsewhere in the prostate. However, 77% of men with TZ cancer had a PSA of > 10 ng/mL, compared with 60% of men with cancer at other sites within the prostate (P = 0.015). CONCLUSION: An extended-core biopsy protocol significantly improves the detection rate for prostate cancer when compared with the standard sextant biopsy protocol alone. Routine TZ biopsies should be considered for men with serum PSA levels of >10 ng/mL.     

Prostatic Transrectal Ultrasound (TRUS) Guided Biopsy Schemes and TRUS Prostatic Lesion-Guided Biopsies

Objectives: Recent data support the sextant TRUS guided biopsy scheme of the prostate and TRUS prostatic lesion-guided biopsies are inadequate to detect all clinically important cancers. Consequently, different types of schemes with more than six biopsies have recently been proposed. The type of scheme and the number of biopsies needed to optimize the detection rate of prostate cancer is still a somewhat controversial issue. In order to draw attention to the most interesting issues and controversies involving needle biopsies, we describe not only the most common methods used but also some of the new schemes proposed in literature.Methods: Literature on prostate biopsy was reviewed and a selection of articles made. Keywords used for the Medline search included: prostate cancer, biopsy, transrectal ultrasound and diagnosis.Results: Over the last few years, an increasing number of investigators have modified the standard sextant biopsy scheme, increasing the number and areas of the prostate sampled, especially biopsies taken more laterally or in the anterior horn or medially towards the apex of the prostate. Cancer yield does not appear to be related solely to the number of biopsies but also to the regions of the prostate sampled.Conclusions: In the current PSA era, prostatic biopsies only performed at lesions detected by TRUS are obsolete. Sextant and lesion-directed biopsies maximizes detection rate using the lowest possible number of biopsy cores if hypoechoic lesions are clearly visible. In the case of a negative TRUS and/or digital rectal examination, the ideal number of cores and prostate areas requiring sampling is still not defined, but the use of 10 or 12 multiple biopsies is becoming routine in many centers. In the future, biopsy techniques will probably be individualized for each patient according to TRUS findings, prostatic volume and PSA levels.     

A comparative analysis of sextant and an extended 11-core multisite directed biopsy strategy

PURPOSE: The 3 tumor locations unsampled by conventional sextant biopsies that have been identified on composite 3-dimensional reconstruction of 180 radical prostatectomy specimens are the anterior transition zone, midline peripheral zone and inferior portions of the anterior horn in the peripheral zone. We evaluated an 11-core multisite directed biopsy scheme incorporating these alternate areas and conventional sextant biopsies in 362 patients from 2 institutions. MATERIALS AND METHODS: Patients without a prior diagnosis of cancer underwent ultrasound guided 11-core biopsies which included conventional sextant and 3 alternate sites. All specimens were separated for specific location identification. Biopsy was performed in 183 patients at MD Anderson Cancer Center (group 1) and in 179 at Toronto General Hospital (group 2). All group 2 and 54% of group 1 patients (98 of 183) had a prior biopsy negative for cancer. RESULTS: Median prostate specific antigen was higher in group 2 than in group 1 patients (11.5 versus 9.5 ng./ml., p = 0.016). Overall a 33% increase (36 of 110 patients) in cancer detection was observed when biopsy technique included the alternate areas (p = 0.0021). The anterior horn was the most frequently positive biopsy site followed by the transition zone and midline sites. The 11-core technique had significantly better cancer detection rates when digital rectal examination and transrectal ultrasound were normal, and in men with serum prostate specific antigen between 4.1 and 10 ng./ml. CONCLUSIONS: Biopsies of the alternate sites suggested by our simulation studies are feasible and reproducible. This new strategy significantly enhanced (p = 0.0075) prostate cancer detection compared to conventional sextant biopsies in men undergoing a repeat procedure.