22 results on '"Gomella, Leonard G."'
Search Results
2. Preventing Prostate Biopsy Complications: to Augment or to Swab?
- Author
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Glick L, Vincent SA, Squadron D, Han TM, Syed K, Danella JF, Ginzburg S, Guzzo TJ, Lanchoney T, Raman JD, Smaldone M, Uzzo RG, Tomaszweski JJ, Reese A, Singer EA, Jacobs B, Trabulsi EJ, Gomella LG, and Mann MJ
- Subjects
- Aged, Aged, 80 and over, Humans, Male, Rectum, Retrospective Studies, Risk Assessment, Antibiotic Prophylaxis, Bacterial Infections prevention & control, Image-Guided Biopsy adverse effects, Image-Guided Biopsy methods, Postoperative Complications etiology, Postoperative Complications prevention & control, Prostate pathology, Ultrasonography, Interventional
- Abstract
Objective: To use data from a large, prospectively- acquired regional collaborative database to compare the risk of infectious complications associated with three American Urologic Association- recommended antibiotic prophylaxis pathways, including culture-directed or augmented antibiotics, following prostate biopsy., Methods: Data on prostate biopsies and outcomes were collected from the Pennsylvania Urologic Regional Collaborative, a regional quality collaborative working to improve the diagnosis and treatment of prostate cancer. Patients were categorized as receiving one of three prophylaxis pathways: culture-directed, augmented, or provider-discretion. Infectious complications included fever, urinary tract infections or sepsis within one month of biopsy. Odds ratios of infectious complication by pathway were determined, and univariate and multivariate analyses of patient and biopsy characteristics were performed., Results: 11,940 biopsies were included, 120 of which resulted in infectious outcomes. Of the total biopsies, 3246 used "culture-directed", 1446 used "augmented" and 7207 used "provider-discretion" prophylaxis. Compared to provider-discretion, the culture-directed pathway had 84% less chance of any infectious outcome (OR= 0.159, 95% CI = [0.074, 0.344], P < 0.001). There was no difference in infectious complications between augmented and provider-discretion pathways., Conclusions: The culture-directed pathway for transrectal prostate biopsy resulted in significantly fewer infectious complications compared to other prophylaxis strategies. Tailoring antibiotics addresses antibiotic-resistant bacteria and reduces future risk of resistance. These findings make a strong case for incorporating culture-directed antibiotic prophylaxis into clinical practice guidelines to reduce infection following prostate biopsies., (Copyright © 2021. Published by Elsevier Inc.)
- Published
- 2021
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3. Questioning the Status Quo: Should Gleason Grade Group 1 Prostate Cancer be Considered a "Negative Core" in Pre-Radical Prostatectomy Risk Nomograms? An International Multicenter Analysis.
- Author
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Leong JY, Herrera-Caceres JO, Goldberg H, Tham E, Teplitsky S, Gomella LG, Trabulsi EJ, Lallas CD, Fleshner NE, Tilki D, and Chandrasekar T
- Subjects
- Aged, Biopsy methods, Biopsy statistics & numerical data, Humans, Lymph Nodes pathology, Male, Middle Aged, Neoplasm Invasiveness, Neoplasm Staging, Nomograms, Predictive Value of Tests, Preoperative Care methods, Retrospective Studies, Neoplasm Grading methods, Prostate pathology, Prostate surgery, Prostatectomy adverse effects, Prostatectomy methods, Prostatic Neoplasms pathology, Prostatic Neoplasms surgery, Risk Assessment methods
- Abstract
Objective: To assess the impact of excluding Gleason Grade Group 1 (GG1) prostate cancer (CaP) cores from current pre-radical prostatectomy (RP) nomograms., Methods: Multi-institutional retrospective chart review was performed on all RP patients with prostate biopsy between 2008 and 2018. Patients were individually assessed using the Memorial Sloan Kettering Cancer Center (MSKCC) and Briganti nomograms using the following iterations: (1) Original [ORIG] - all available core data and (2) Selective [SEL] - GG1 cores considered negative. Nomogram outcomes - lymph node invasion (LNI), extracapsular extension (ECE), organ-confined disease (OCD), seminal vesicle invasion (SVI), were compared across iterations and stratified based on biopsy GG. Clinically significant impact on management (CSIM) was defined as change in LNI risk above or below 2% or 5% (Δ2/Δ5). Nomogram outcomes were validated with RP pathology., Results: 7718 men met inclusion criteria. In men with GG2 who also had GG1 cores, SEL better predicted LNI (MSKCC - ORIG 4.97% vs SEL 3.50%; Briganti - ORIG 4.81% vs SEL 2.49%, RP outcome 2.46%), OCD (MSKCC - ORIG 40.91% vs SEL 48.44%, RP outcome: 68.46%) and ECE (MSKCC - ORIG 57.87% vs SEL 50.38%, RP outcome: 30.41%), but not SVI (MSKCC - ORIG 5.42% vs SEL 3.34%, RP outcome: 5.62%). This was also consistent in patients with GG3-5 disease. The greatest CSIM was on GG1-2 CaP; Δ2 and Δ5 in GG1 patients was 26.3%-31.0% and 1.5%-5.2%, respectively, and Δ2 and Δ5 in GG2 patients was 3.4%-22.2% and 12.3%-13.6%, respectively., Conclusion: Excluding GG1 CaP cores from pre-RP nomograms better predicts final RP pathologic outcomes. More importantly, this may better reflect extent of true cancer burden., (Copyright © 2019 Elsevier Inc. All rights reserved.)
- Published
- 2020
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4. Hospital-specific antibiograms and antibiotic prophylaxis for prostate biopsies: a reexamination of AUA recommendations.
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Mann M, Calio BP, Mark JR, Chelluri R, Hufnagel E, Reese A, Lallas CD, Trabulsi EJ, Chandrasekar T, Shenot PJ, Halpern E, and Gomella LG
- Subjects
- Biopsy, Hospitals, Humans, Male, Microbial Sensitivity Tests, Antibiotic Prophylaxis, Postoperative Complications prevention & control, Practice Guidelines as Topic, Prostate pathology, Urinary Tract Infections prevention & control
- Abstract
Introduction: To assess whether standard American Urological Association (AUA) and other recommendations for prostate biopsy prophylaxis provide sufficient coverage of common urinary organisms responsible for post biopsy infections by comparing local antibiograms in Philadelphia-area hospitals., Materials and Methods: De-identified culture results derived from antibiograms were collected from six academic and community hospitals in the Philadelphia region. Analysis specifically focused on four major bacterial causes of urinary tract infection following prostate biopsy (Escherichia coli (E. coli), Klebsiella pneumoniae, Proteus mirabilis and Enterococcus faecalis) along with commonly recommended antibiotics including fluoroquinolones (FQ's), trimethoprim/sulfamethoxazole, ceftriaxone, and gentamicin., Results: Bacterial sensitivities to each antibiotic across institutions showed variation in E.coli sensitivities to FQs (p < 0.001), trimethoprim/sulfamethoxazole (p < 0.001), ceftriaxone (p < 0.001) and gentamicin (p < 0.001). Klebsiella pneumoniae and Proteus mirabilis exhibited similar variations. Sensitivity comparisons for Enterococcus faecalis was unable to be performed due to absent or incomplete data across institutions., Conclusion: Institutional antibiograms vary within our regional hospitals. Standardized recommendations for commonly used antibiotic prophylaxis such as fluoroquinolones may be inadequate for peri-procedural prostate biopsy prophylaxis based on local resistance patterns. Valuable information about the potential effectiveness of antibiotic prophylaxis for prostate biopsies can be found in local institutional antibiograms, and should be consulted when considering antibiotic prophylaxis for prostate biopsy procedures.
- Published
- 2020
5. Prostate Contrast Enhanced Transrectal Ultrasound Evaluation of the Prostate With Whole-Mount Prostatectomy Correlation.
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Trabulsi EJ, Calio BP, Kamel SI, Gomella LG, Forsberg F, McCue P, and Halpern EJ
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- Correlation of Data, Humans, Male, Prostatic Neoplasms surgery, Rectum, Retrospective Studies, Ultrasonography methods, Contrast Media, Prostate diagnostic imaging, Prostatectomy, Prostatic Neoplasms diagnostic imaging, Prostatic Neoplasms pathology
- Abstract
Objective: To investigate the diagnostic accuracy of contrast enhanced transrectal ultrasound (CE-TRUS) in comparison with whole-mount radical prostatectomy specimens., Method and Materials: Fifty-eight subjects who underwent CE-TRUS and subsequent radical prostatectomy with whole-mount pathology were included in the study. Each patient underwent evaluation with baseline TRUS and again during CE-TRUS with intravenous infusion of perflutren lipid microsphere (Definity, Lantheus Medical Imaging, N Billerica, MA). A subjective 5 point scale was used to rate each sextant of the prostate in 3 baseline imaging modes and in 5 contrast-enhanced imaging modes. Baseline TRUS and CE-TRUS findings were compared with digitized whole-mount findings. A clustered logistic regression model was computed to compare the area under the receiver operating characteristic curve (A
z ) for detection of prostate cancer by various modes of ultrasound imaging., Results: Among the 58 whole-mount specimens, a maximum Gleason score of 6 was identified in 29 subjects, a score of 7 was identified in 24 and a score of 8 was identified in 5. The Az for baseline TRUS parameters was 0.55 for grayscale, 0.61 for color Doppler and 0.59 for power Doppler. CE-TRUS parameters demonstrated significant increases in Az with the highest Az for CE-power Doppler (0.66) and flash replenishment imaging (0.64) (P = .04 for comparison to baseline). The combination of CE-power Doppler and flash replenishment imaging resulted in improved Az compared with baseline imaging (0.70 vs 0.59, P= .006)., Conclusion: Contrast-enhanced ultrasonography demonstrates greater diagnostic accuracy than baseline imaging. Diagnostic accuracy is further improved for "clinically significant" tumor volumes >1 cc., (Copyright © 2019 Elsevier Inc. All rights reserved.)- Published
- 2019
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6. VPAC1-targeted PET/CT scan: improved molecular imaging for the diagnosis of prostate cancer using a novel cell surface antigen.
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Truong H, Gomella LG, Thakur ML, and Trabulsi EJ
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- Diagnosis, Differential, Early Detection of Cancer methods, Humans, Male, Radiopharmaceuticals pharmacology, Copper Radioisotopes pharmacology, Positron Emission Tomography Computed Tomography methods, Prostate diagnostic imaging, Prostatic Hyperplasia diagnosis, Prostatic Neoplasms diagnosis, Prostatic Neoplasms metabolism, Receptors, Vasoactive Intestinal Polypeptide, Type I metabolism
- Abstract
Purpose: Current approaches to prostate cancer screening and diagnosis are plagued with limitations in diagnostic accuracy. There is a compelling need for biomolecular imaging that will not only detect prostate cancer early but also distinguish prostate cancer from benign lesions accurately. In this topic paper, we review evidence that supports further investigation of VPAC1-targeted PET/CT imaging in the primary diagnosis of prostate cancer., Methods: A non-systematic review of Medline/PubMed was performed. English language guidelines on prostate cancer diagnosis and management, original articles, and review articles were selected based on their clinical relevance., Results: VPAC1 receptors were overexpressed 1000 times more in prostate cancer than benign prostatic stromal tissue. In vitro and in vivo studies showed that Copper-64 labeled analogs of VPAC1 ligands can be synthesized with high radiochemical efficiency and purity. The radioactive probes had excellent VPAC1 receptor binding specificity and affinity. They had good biochemical stability in vitro and in mouse and human serum. They had minimal urinary excretion, which made them favorable for prostate cancer imaging. Initial feasibility study in men with prostate cancer showed that the probes were safe with no reported adverse reaction.
64 Cu-TP3805 PET/CT detected 98% of prostate cancer lesions and nodal metastasis as confirmed with whole mount histopathological evaluation., Conclusions: VPAC1 receptors are promising targets for biomolecular imaging of primary prostate cancer that can distinguish malignant from benign lesions non-invasively. Further investigations are warranted to validate initial findings and define the clinical utilities of VPAC1-targeted PET imaging for prostate cancer diagnosis and management.- Published
- 2018
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7. Predictors of positive surgical margins after radical prostatectomy at a single institution: preoperative and pathologic factors, and the impact of surgeon variability and technique on incidence and location.
- Author
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Lallas CD, Fashola Y, Den RB, Gelpi-Hammerschmidt F, Calvaresi AE, McCue P, Birbe R, Gomella LG, and Trabulsi EJ
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- Age Factors, Humans, Male, Middle Aged, Neoplasm Grading, Neoplasm Invasiveness, Neoplasm Staging, Neoplasm, Residual, Organ Size, Peripheral Nerves pathology, Prostatic Neoplasms blood, Retrospective Studies, Risk Factors, Robotic Surgical Procedures, Neoplasm Recurrence, Local blood, Prostate pathology, Prostate-Specific Antigen blood, Prostatectomy methods, Prostatic Neoplasms pathology, Prostatic Neoplasms surgery
- Abstract
Introduction: To identify and assess predictive factors for positive surgical margins (PSM) in patients undergoing radical prostatectomy (RP)., Materials and Methods: An Institution Review Board (IRB) approved retrospective review of 1751 patients that underwent RP from March 2000 to June 2013 was performed. Identified were 1740 patients whom had not received neoadjuvant therapy; these were used for the purpose of this analysis. Univariate and multivariate analysis were performed to determine factors associated with and predictive of PSMs, divided into preoperative and pathological. Variables analyzed include age, body mass index (BMI), race, surgeon, surgical modality, pathologic T-stage and Gleason sum, extracapsular extension (ECE), seminal vesicle involvement (SVI), perineural invasion (PNI) and prostate weight. Finally, each surgical technique was analyzed to determine the most common site of PSM., Results: Rate of PSM was 23.6%. Our analysis showed that preoperative prostate-specific antigen (PSA) level ≥ 10ng/mL, and pathologic T3/T4-stage and PNI significantly predicted PSM. Age > 60 years and prostate weight > 60 g were predictive against PSM. Gleason score ≥ 7 and PSM were significant risk factors for biochemical recurrence (BCR). Surgical approach did not affect the rate of PSM. Open RP was associated with a higher apical PSM rate (38.5%) and robotic RP with a higher posterolateral PSM rate (52.3%)., Conclusions: High preoperative PSA levels, and advanced TNM-staging predicted positive surgical margins in our cohort. Patients with PSM were subsequently found to have higher risk of BCR.
- Published
- 2014
8. Recommendations for adjuvant post prostatectomy radiation.
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Gomella LG
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- Humans, Male, Neoplasm Recurrence, Local epidemiology, Prostate pathology, Prostate surgery, Prostatectomy methods, Prostatic Neoplasms surgery, Robotics, Surgery, Computer-Assisted methods
- Published
- 2014
9. Transrectal prostate biopsy.
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Ismail MT and Gomella LG
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- Biopsy methods, Humans, Male, Prostate diagnostic imaging, Prostate-Specific Antigen blood, Prostatic Neoplasms blood, Prostatic Neoplasms diagnostic imaging, Rectum, Ultrasonography, Interventional, Prostate pathology, Prostatic Neoplasms pathology
- Abstract
Grayscale transrectal ultrasonographic prostate biopsy using local anesthesia remains the standard approach to the definitive diagnosis of prostate cancer. Careful patient evaluation and preparation are essential to maximize the results and minimize the complications of the biopsy procedure., (Copyright © 2013 Elsevier Inc. All rights reserved.)
- Published
- 2013
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10. The quest for the perfect prostate biopsy continues.
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Gomella LG
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- Humans, Male, Biomarkers, Tumor blood, Elasticity Imaging Techniques, Magnetic Resonance Imaging, Neoplasm Recurrence, Local etiology, Prostate diagnostic imaging, Prostate pathology, Prostate-Specific Antigen blood, Prostatic Neoplasms diagnosis, Prostatic Neoplasms diagnostic imaging, Prostatic Neoplasms pathology
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- 2012
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11. Enhanced transrectal ultrasound modalities in the diagnosis of prostate cancer.
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Trabulsi EJ, Sackett D, Gomella LG, and Halpern EJ
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- Adenocarcinoma, Biopsy, Needle, Contrast Media, Elasticity Imaging Techniques, Humans, Imaging, Three-Dimensional, Male, Prostate pathology, Prostatic Neoplasms blood supply, Prostatic Neoplasms diagnosis, Ultrasonography, Doppler, Color, Ultrasonography, Interventional, Prostate diagnostic imaging, Prostatic Neoplasms diagnostic imaging
- Abstract
Standard grayscale transrectal ultrasound has a poor sensitivity for detection of prostate cancer. Saturation biopsy schemes have improved prostate cancer detection rates over standard template biopsy schemes, but carry additional morbidity and cost. Enhanced ultrasound modalities (EUM), including color and power Doppler, contrast-enhancement, harmonic and flash replenishment imaging, and elastography have demonstrated improved prostate cancer detection. EUM targeting areas with increased or abnormal vascularity or firmness for biopsy offer improved prostate cancer detection. EUM, detect prostate cancer more efficiently than standard ultrasound guided biopsies. These emerging technologies may potentially augment standard prostate biopsy in clinical practice., (Copyright © 2010 Elsevier Inc. All rights reserved.)
- Published
- 2010
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12. Targeted biopsy of the prostate: the impact of color Doppler imaging and elastography on prostate cancer detection and Gleason score.
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Nelson ED, Slotoroff CB, Gomella LG, and Halpern EJ
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- Adult, Aged, Aged, 80 and over, Humans, Male, Middle Aged, Predictive Value of Tests, Prostate diagnostic imaging, Prostatic Neoplasms diagnostic imaging, Sensitivity and Specificity, Ultrasonography, Interventional, Biopsy, Needle methods, Elasticity Imaging Techniques, Prostate pathology, Prostatic Neoplasms diagnosis, Ultrasonography, Doppler, Color
- Abstract
Objectives: To compare detection of prostate cancer and distribution of Gleason scores with gray-scale, color Doppler, and elastographic imaging., Methods: Prostate biopsy patients were evaluated with gray-scale, color Doppler, and elastographic imaging. Targeted biopsy cores were obtained along with six laterally directed systematic sextant cores. Pathologic results were correlated with imaging findings., Results: Prostate cancer was detected in 60 of 137 patients (43.8%). Cancer was detected in 241 (14%) of 1703 biopsy cores, including 90 (20%) of 448 targeted cores, 106 (13%) of 818 sextant cores, and 45 (10%) of 437 transition zone cores. Sonographic abnormality was associated with cancer: gray-scale odds ratio (OR) = 3.19, P = 0.011; color Doppler OR = 1.86, P = 0.041; elastography OR = 2.53; P = 0.007. Although targeted cores were more likely than sextant cores to detect cancer (OR = 1.82, P = 0.004), no sonographic abnormality was found in 57 (53.8%) of 106 of positive sextant sites. A linear trend for increasing Gleason score was present with gray-scale (P <0.001) imaging, color Doppler imaging (P <0.005), and elastography (P <0.001). Abnormal color flow was strongly associated with Gleason score 8 to 10 lesions but not with lower-grade lesions. Elastography demonstrated a positive association with Gleason scores of 5 to 10., Conclusions: Targeted cores based on gray-scale, color Doppler, and elastographic imaging are more likely to return positive biopsy results as compared with systematic biopsy cores. Although color Doppler imaging and elastography are encouraging adjuncts to improve cancer detection, targeted biopsy alone is not sufficient to replace the traditional sextant biopsy technique.
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- 2007
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13. Effect of dutasteride therapy on Doppler US evaluation of prostate: preliminary results.
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Ives EP, Gomella LG, and Halpern EJ
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- Aged, Azasteroids therapeutic use, Biopsy, Dutasteride, Humans, Male, Middle Aged, Prospective Studies, Prostate pathology, Prostatic Hyperplasia drug therapy, Prostatic Neoplasms pathology, Azasteroids pharmacology, Prostate diagnostic imaging, Prostate drug effects, Prostatic Hyperplasia diagnostic imaging, Prostatic Neoplasms diagnostic imaging, Ultrasonography, Doppler
- Abstract
Purpose: To prospectively determine the effect of short-term therapy with dutasteride on the suppression of Doppler ultrasonographic (US) signal in benign prostate tissue and thus on improvement in the depiction of prostate cancer with Doppler US-guided core-needle biopsy., Materials and Methods: After institutional review board approval and informed consent were obtained as part of this HIPAA-compliant study, 11 men (age range, 59-77 years) were evaluated with gray-scale, color, and power Doppler US at baseline and weekly for up to 3 weeks while taking 0.5 mg of dutasteride per day. Flow intensity in the periurethral, transition, and peripheral zones was subjectively scored by using a four-point scale. The Wilcoxon matched-pairs signed-ranks test was used to compare pre- and posttherapy scores. After flow was reduced to "diminished" or "none" with at least a 1-score difference on the four-point scale, up to four targeted cores were obtained from areas of persistent flow within the peripheral zone, followed by laterally directed sextant biopsy., Results: Doppler US flow suppression occurred in 11 of 11 patients after 1 week of dutasteride therapy (P < .01). Further suppression was noted after 2 weeks in eight of 10 patients (P = .04) and after 3 weeks in two of two patients. Biopsy was performed after 1 (n = 1), 2 (n = 8), or 3 (n = 2) weeks of therapy. Flow suppression was greatest in the peripheral zones (mean decrease: 0.64 and 0.76 after weeks 1 and 2, respectively) and least in the periurethral zones (mean decrease: 0.30 after 1 week). Cancer was detected in eight (20%) of 40 targeted cores and in five (8%) of 66 sextant cores. Four patients had cancer at targeted biopsy, and three of these four patients had cancer at sextant biopsy. In the four men with cancer, targeted cores were 5.9 times more likely to be positive (P = .027). Selective suppression of flow in benign tissue was observed in two of the four men with cancer., Conclusion: Short-term dutasteride therapy reduces Doppler US flow in the prostate and may improve depiction of hypervascular cancer., (RSNA, 2005)
- Published
- 2005
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14. Directed biopsy during contrast-enhanced sonography of the prostate.
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Halpern EJ, Frauscher F, Rosenberg M, and Gomella LG
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- Adult, Aged, Aged, 80 and over, False Positive Reactions, Fluorocarbons, Humans, Logistic Models, Male, Microspheres, Middle Aged, Odds Ratio, Prostatic Neoplasms diagnostic imaging, Prostatic Neoplasms pathology, Sensitivity and Specificity, Biopsy, Needle methods, Contrast Media administration & dosage, Prostate diagnostic imaging, Prostate pathology, Prostatic Neoplasms diagnosis, Ultrasonography, Interventional
- Abstract
Objective: We evaluated the value of directed biopsy for the detection of prostate cancer during contrast-enhanced endorectal sonography., Subjects and Methods: Forty patients were evaluated with harmonic gray-scale sonography. The evaluation was performed before administration of contrast agent, during continuous IV infusion of perflutren lipid microspheres, and again during bolus administration of the microspheres. Sextant biopsy sites were scored prospectively on a six-point scale for suggestion of malignancy at baseline during contrast infusion and after bolus administration. An additional directed core was obtained at 20 of the sextant biopsy sites based on contrast-enhanced imaging., Results: Cancer was identified in 30 biopsy sites in 16 of the patients (40%). A suspicious site identified during contrast-enhanced transrectal sonography was 3.5 times more likely to have positive biopsy findings at than an adjacent site that was not suggestive of malignancy (p < 0.025). When a suspicious site was evaluated with an additional biopsy core, the site was five times more likely to have a biopsy with positive findings than a standard sextant site (p < 0.01). We found no difference in diagnostic accuracy between continuous infusion of contrast material and bolus administration., Conclusion: Contrast-enhanced transrectal sonography improves the sonographic detection of malignant foci in the prostate. The performance of multiple biopsies of suspicious enhancing foci significantly improves the detection of cancer. There is no advantage to additional examination of the gland after bolus administration of contrast material.
- Published
- 2002
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15. High-frequency Doppler US of the prostate: effect of patient position.
- Author
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Halpern EJ, Frauscher F, Forsberg F, Strup SE, Nazarian LN, O'Kane P, and Gomella LG
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- Adult, Aged, Biopsy, Needle, Blood Flow Velocity, Humans, Male, Middle Aged, Posture, Prostate blood supply, Prostate pathology, Prostatic Neoplasms blood supply, Prostatic Neoplasms diagnosis, Prostatic Neoplasms diagnostic imaging, Ultrasonography, Doppler, Color, Ultrasonography, Interventional, Prostate diagnostic imaging, Ultrasonography, Doppler
- Abstract
Purpose: To evaluate cancer detection with directed biopsy of the prostate on the basis of high-frequency Doppler ultrasonographic (US) findings, and to determine the effect of patient position on the observed flow pattern., Materials and Methods: Thirty-two patients were evaluated in the left lateral decubitus position with gray-scale, color Doppler, and power Doppler transrectal US. Up to four directed biopsy specimens were obtained on the basis of gray-scale and Doppler US findings, and modified sextant biopsy followed. Analysis of variance and the Wilcoxon signed rank test were used to evaluate the distribution of Doppler signals within the prostate. Three healthy volunteers with no known prostate disease were also examined in supine and both decubitus positions., Results: In the patient group, both color and power Doppler US demonstrated increased flow on the left side of the prostate, with greater flow toward the base of the gland (P <.002). Consequently, 62 of 90 directed-biopsy cores were obtained in the left base and mid-gland. The positive biopsy rate for directed biopsy was not significantly different from that of sextant biopsy (P =.4). Seven patients had cancer that was identified with sextant biopsy, but only four cancers were identified with directed biopsy. Each of the three healthy volunteers demonstrated increased Doppler flow on the dependent side when the subject was in the lateral decubitus position., Conclusion: The positive yield of directed biopsy was similar to the yield of sextant biopsy. On the basis of observations made in healthy volunteers, the authors conclude that flow asymmetry in patients who underwent biopsy may have been related to patient position.
- Published
- 2002
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16. Potential Impact on Clinical Decision Making via a Genome-Wide Expression Profiling: A Case Report
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Kim, Hyun, Alshalalfa, Mohammed, Hoffman-Censits, Jean, Lallas, Costas D, Davicioni, Elai, Lin, Jianqing, Birbe, Ruth, Erho, Nicholas, Lehrer, Jonathan, Ashab, Hussam Al-Deen, Takhar, Mandeep, Olson, Anders, Lam, Lucia LC, Kelly, W Kevin, Knudsen, Karen E, Thangavel, Chellappagounder, Seiler, Roland, Feng, Felix Y, Schaeffer, Edward M, Trabulsi, Edouard J, Gomella, Leonard G, Hurwitz, Mark D, Dicker, Adam P, and Den, Robert B
- Subjects
Biomedical and Clinical Sciences ,Clinical Sciences ,Oncology and Carcinogenesis ,Cancer ,Rare Diseases ,Clinical Research ,Health Services ,Aging ,Human Genome ,Genetics ,Urologic Diseases ,Patient Safety ,Clinical Trials and Supportive Activities ,Prostate Cancer ,Behavioral and Social Science ,Biotechnology ,Detection ,screening and diagnosis ,4.2 Evaluation of markers and technologies ,Prostate ,Neuroendocrine ,Genomics ,Clinical sciences - Abstract
Management of men with prostate cancer is fraught with uncertainty as physicians and patients balance efficacy with potential toxicity and diminished quality of life. Utilization of genomics as a prognostic biomarker has improved the informed decision-making process by enabling more rationale treatment choices. Recently investigations have begun to determine whether genomic information from tumor transcriptome data can be used to impact clinical decision-making beyond prognosis. Here we discuss the potential of genomics to alter management of a patient who presented with high-risk prostate adenocarcinoma. We suggest that this information help selecting patients for advanced imaging, chemotherapies, or clinical trial.
- Published
- 2016
17. Contrast Enhanced Ultrasound Flash Replenishment Method for Directed Prostate Biopsies.
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Linden, Robert A., Trabulsi, Edouard J., Forsberg, Flemming, Gittens, Paul R., Gomella, Leonard G., and Halpern, Ethan J.
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PROSTATE ,BIOPSY ,CANCER ,MEDICAL imaging systems - Abstract
Purpose: We evaluated prostate cancer detection with contrast enhanced ultrasound of the prostate using MicroFlow Imaging (Toshiba America Medical Systems, Tustin, California) compared to systematic biopsy. Materials and Methods: A total of 60 patients referred for prostate biopsy were evaluated with pre-contrast and contrast enhanced MicroFlow Imaging transrectal ultrasound. MicroFlow Imaging is a flash replenishment technique that uses high power flash pulses to destroy contrast microbubbles, followed by low power pulses to demonstrate contrast replenishment. A composite image depicting the vascular architecture is constructed through maximum intensity capture of temporal data in consecutive low power images. Using MicroFlow Imaging up to 5 directed biopsy cores were obtained from areas of abnormal vascular enhancement or morphology, followed by a systematic 10-core biopsy protocol. Results: A biopsy positive for cancer was found in 79 of the 825 cores (10%) from 18 of the 60 subjects (30%). Positive biopsies were obtained in 50 of 600 systematic core biopsies (8.3%) and in 29 of 225 directed cores (13%) (OR 2.02, p = 0.034). Five of the 18 patients diagnosed with cancer were identified only by systematic biopsy, 2 were identified only by directed biopsy with MicroFlow Imaging and 11 were identified by the 2 techniques (p >0.25). Twice the number of patients was detected per core with directed vs systematic biopsy (0.058 vs 0.027). Conclusions: The vascular detail provided by MicroFlow Imaging allowed directed biopsy of these areas with increased detection of prostate cancer. Although a minority of cancers were not detected with MicroFlow Imaging directed biopsy, this technique detected twice as many patients with prostate cancer per biopsy core. [Copyright &y& Elsevier]
- Published
- 2007
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18. 1478: Targeted Biopsy of the Prostate with Contrast-Enhanced Transrectal Sonography in Patients with Previous Negative Biopsy.
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Ramey, John R., Halpern, Ethan J., and Gomella, Leonard G.
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ULTRASONIC imaging ,BIOPSY ,PROSTATE - Published
- 2005
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19. 1719: Detection of Prostate Cancer with Contrast Enhanced Sonography Using Harmonic Gray Scale, Color Doppler and Power Doppler Imaging.
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Halpern, Ethan J., Ramey, John R., Frauscher, Ferdinand, McCue, Peter, and Gomella, Leonard G.
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PROSTATE ,PROSTATE cancer ,ULTRASONIC imaging ,CANCER - Published
- 2005
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20. 1535: Quantitative CT Perfusion of Prostate Cancer: Correlation with whole Mount Pathology.
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Ives, Elizabeth P., Burke, Melissa A., Edmonds, Pamela R., Gomella, Leonard G., and Halpern, Ethan J.
- Subjects
PROSTATE ,PROSTATE cancer ,STATISTICAL correlation ,PERFUSION ,PATHOLOGY - Published
- 2005
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21. The addition of androgen deprivation therapy and pelvic lymph node treatment to prostate bed salvage radiotherapy (NRG Oncology/RTOG 0534 SPPORT): an international, multicentre, randomised phase 3 trial.
- Author
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Pollack, Alan, Karrison, Theodore G, Balogh, Alexander G, Gomella, Leonard G, Low, Daniel A, Bruner, Deborah W, Wefel, Jeffrey S, Martin, Andre-Guy, Michalski, Jeff M, Angyalfi, Steve J, Lukka, Himanshu, Faria, Sergio L, Rodrigues, George B, Beauchemin, Marie-Claude, Lee, R Jeffrey, Seaward, Samantha A, Allen, Aaron M, Monitto, Drew C, Seiferheld, Wendy, and Sartor, Oliver
- Subjects
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RESEARCH , *ANTIANDROGENS , *CLINICAL trials , *ANDROGENS , *RESEARCH methodology , *PROSTATE , *LYMPH nodes , *EVALUATION research , *COMPARATIVE studies , *RANDOMIZED controlled trials , *RESEARCH funding , *RADIOTHERAPY , *SALVAGE therapy , *PROSTATE-specific antigen , *PROSTATE tumors , *ONCOLOGY - Abstract
Background: In men with a detectable prostate-specific antigen (PSA) level after prostatectomy for prostate cancer, salvage prostate bed radiotherapy (PBRT) results in about 70% of patients being free of progression at 5 years. A three-group randomised trial was designed to determine whether incremental gains in patient outcomes can be achieved by adding either 4-6 months of short-term androgen deprivation therapy (ADT) to PBRT, or both short-term ADT and pelvic lymph node radiotherapy (PLNRT) to PBRT.Methods: The international, multicentre, randomised, controlled SPPORT trial was done at 283 radiation oncology cancer treatment centres in the USA, Canada, and Israel. Eligible patients (aged ≥18 years) were those who after prostatectomy for adenocarcinoma of the prostate had a persistently detectable or an initially undetectable and rising PSA of between 0·1 and 2·0 ng/mL. Patients with and without lymphadenectomy (N0/Nx) were eligible if there was no clinical or pathological evidence of lymph node involvement. Other eligibility criteria included pT2 or pT3 disease, prostatectomy Gleason score of 9 or less, and a Zubrod performance status of 0-1. Eligible patients were randomly assigned to receive PBRT alone at a dose of 64·8-70·2 Gy at 1·8 Gy per fraction daily (group 1), PBRT plus short-term ADT (group 2), or PLNRT (45 Gy at 1·8 Gy per fraction, and then a volume reduction made to the planning target volume for the remaining 19·8-25 ·2 Gy) plus PBRT plus short-term ADT (group 3). The primary endpoint was freedom from progression, in which progression was defined as biochemical failure according to the Phoenix definition (PSA ≥2 ng/mL over the nadir PSA), clinical failure (local, regional, or distant), or death from any cause. A planned interim analysis of 1191 patents with minimum potential follow-up time of 5 years applied a Haybittle-Peto boundary of p<0·001 (one sided) for comparison of 5-year freedom from progression rates between the treatment groups. This trial is registered with ClinicalTrials.gov, NCT00567580. The primary objectives of the trial have been completed, although long-term follow-up is continuing.Findings: Between March 31, 2008, and March 30, 2015, 1792 eligible patients were enrolled and randomly assigned to the three treatment groups (592 to group 1 [PBRT alone], 602 to group 2 [PBRT plus short-term ADT], and 598 to group 3 [PLNRT plus PBRT plus short-term ADT]). 76 patients subsequently found to be ineligible were excluded from the analyses; thus, the evaluable patient population comprised 1716 patients. At the interim analysis (n=1191 patients; data cutoff May 23, 2018), the Haybittle-Peto boundary for 5-year freedom from progression was exceeded when group 1 was compared with group 3 (difference 17·9%, SE 2·9%; p<0·0001). The difference between groups 2 and 3 did not exceed the boundary (p=0·0063). With additional follow-up beyond the interim analysis (the final planned analysis; data cutoff May 26, 2021), at a median follow-up among survivors of 8·2 years (IQR 6·6-9·4), the 5-year freedom from progression rates in all 1716 eligible patients were 70·9% (95% CI 67·0-74·9) in group 1, 81·3% (78·0-84·6) in group 2, and 87·4% (84·7-90·2) in group 3. Per protocol criteria, freedom from progression in group 3 was superior to groups 1 and 2. Acute (≤3 months after radiotherapy) grade 2 or worse adverse events were significantly more common in group 3 (246 [44%] of 563 patients) than in group 2 (201 [36%] of 563; p=0·0034), which, in turn, were more common than in group 1 (98 [18%] of 547; p<0·0001). Similar findings were observed for grade 3 or worse adverse events. However, late toxicity (>3 months after radiotherapy) did not differ significantly between the groups, apart from more late grade 2 or worse blood or bone marrow events in group 3 versus group 2 (one-sided p=0·0060) attributable to the addition of PLNRT in this group.Interpretation: The results of this randomised trial establish the benefit of adding short-term ADT to PBRT to prevent progression in prostate cancer. To our knowledge, these are the first such findings to show that extending salvage radiotherapy to treat the pelvic lymph nodes when combined with short-term ADT results in meaningful reductions in progression after prostatectomy in patients with prostate cancer.Funding: National Cancer Institute. [ABSTRACT FROM AUTHOR]- Published
- 2022
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22. Effect of dutasteride on the risk of prostate cancer
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Andriole, G.L., Bostwick, D.G., Brawley, O.W., Gomella, L.G., Marberger, M., Montorsi, F., Pettaway, C.A., Tammela, T.L.J., Teloken, C., Tindall, D.J., Somerville, M.C., Wilson, T.H., Fowler, I.L., Rittmaster, R.S., Mulders, P.F.A., Schrier, B.P., Department of urology, Università Vita-Salute San Raffaele, Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC ( CEF2P / CARCINO ), Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ) -Université Bourgogne Franche-Comté ( UBFC ) -Université de Franche-Comté ( UFC ), Service de Néphrologie et Urologie, Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ) -Hôpital Saint-Jacques, Andriole Gerald, L., Bostwick David, G., Brawley Otis, W., Gomella Leonard, G., Marberger, Michael, Montorsi, Francesco, Pettaway Curtis, A., Tammela Teuvo, L., Teloken, Claudio, Tindall Donald, J., Somerville Matthew, C., Wilson Timothy, H., Fowler Ivy, L., Rittmaster Roger, S., Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (EA 3181) (CEF2P / CARCINO), Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Service d'urologie, andrologie et transplantation rénale, and Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)-Hôpital Saint-Jacques
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Male ,Relative risk reduction ,Prostate biopsy ,Biopsy ,MESH : Risk ,Prostatic Hyperplasia ,030232 urology & nephrology ,MESH : Aged ,MESH: Protein Isoforms ,[ SDV.CAN ] Life Sciences [q-bio]/Cancer ,MESH: Biopsy ,chemistry.chemical_compound ,Prostate cancer ,5-alpha Reductase Inhibitors ,0302 clinical medicine ,Erectile Dysfunction ,Protein Isoforms ,MESH: Double-Blind Method ,Enzyme Inhibitors ,MESH : Prostate-Specific Antigen ,10. No inequality ,MESH: Treatment Outcome ,MESH: Erectile Dysfunction ,MESH: Aged ,MESH: Risk ,MESH: Middle Aged ,medicine.diagnostic_test ,Prostate ,General Medicine ,Middle Aged ,MESH : Prostatic Hyperplasia ,MESH: Prostate-Specific Antigen ,3. Good health ,Prostate-specific antigen ,Treatment Outcome ,MESH: Enzyme Inhibitors ,030220 oncology & carcinogenesis ,Finasteride ,medicine.symptom ,MESH : Prostatic Neoplasms ,Risk ,medicine.medical_specialty ,MESH : Male ,Urology ,[SDV.CAN]Life Sciences [q-bio]/Cancer ,MESH : Testosterone 5-alpha-Reductase ,MESH : Treatment Outcome ,MESH: Prostate ,MESH: Azasteroids ,MESH: Prostatic Hyperplasia ,03 medical and health sciences ,Double-Blind Method ,Translational research [ONCOL 3] ,medicine ,Humans ,MESH : Double-Blind Method ,MESH : Middle Aged ,MESH: Testosterone 5-alpha-Reductase ,Aged ,MESH : Azasteroids ,Heart Failure ,Gynecology ,MESH : Enzyme Inhibitors ,MESH: Humans ,MESH : Erectile Dysfunction ,business.industry ,Urinary retention ,MESH : Humans ,Prostatic Neoplasms ,MESH : Protein Isoforms ,Dutasteride ,Prostate-Specific Antigen ,medicine.disease ,MESH: Male ,chemistry ,Azasteroids ,MESH: Prostatic Neoplasms ,MESH : Biopsy ,MESH: Heart Failure ,Prostate surgery ,business ,MESH : Heart Failure ,MESH : Prostate - Abstract
Background: We conducted a study to determine whether dutasteride reduces the risk of incident prostate cancer, as detected on biopsy, among men who are at increased risk for the disease. Methods: In this 4-year, multicenter, randomized, double-blind, placebo-controlled, parallel-group study, we compared dutasteride, at a dose of 0.5 mg daily, with placebo. Men were eligible for inclusion in the study if they were 50 to 75 years of age, had a prostate-specific antigen (PSA) level of 2.5 to 10.0 ng per milliliter, and had had one negative prostate biopsy (6 to 12 cores) within 6 months before enrollment. Subjects underwent a 10-core transrectal ultrasound-guided biopsy at 2 and 4 years. Results: Among 6729 men who underwent a biopsy or prostate surgery, cancer was detected in 659 of the 3305 men in the dutasteride group, as compared with 858 of the 3424 men in the placebo group, representing a relative risk reduction with dutasteride of 22.8% (95% confidence interval, 15.2 to 29.8) over the 4-year study period (P
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- 2010
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