Candidates For Prostatectomy Research Articles

68Ga-PSMA-11 PET/MRI in Patients with Newly Diagnosed Intermediate- or High-Risk Prostate Adenocarcinoma: PET Findings Correlate with Outcomes After Definitive Treatment.

Prostate-specific membrane antigen (PSMA) PET offers an accuracy superior to other imaging modalities in initial staging of prostate cancer and is more likely to affect management. We examined the prognostic value of 68Ga-PSMA-11 uptake in the primary lesion and presence of metastatic disease on PET in newly diagnosed prostate cancer patients before initial therapy. Methods: In a prospective study from April 2016 to December 2020, 68Ga-PSMA-11 PET/MRI was performed in men with a new diagnosis of intermediate- or high-grade prostate cancer who were candidates for prostatectomy. Patients were followed up after initial therapy for up to 5 y. We examined the Kendall correlation between PET (intense uptake in the primary lesion and presence of metastatic disease) and clinical and pathologic findings (grade group, extraprostatic extension, nodal involvement) relevant for risk stratification, and examined the relationship between PET findings and outcome using Kaplan-Meier analysis. Results: Seventy-three men (age, 64.0 ± 6.3 y) were imaged. Seventy-two had focal uptake in the prostate, and in 20 (27%) PSMA-avid metastatic disease was identified. Uptake correlated with grade group and prostate-specific antigen (PSA). Presence of PSMA metastasis correlated with grade group and pathologic nodal stage. PSMA PET had higher per-patient positivity than nodal dissection in patients with only 5-15 nodes removed (8/41 vs. 3/41) but lower positivity if more than 15 nodes were removed (13/21 vs. 10/21). High uptake in the primary lesion (SUVmax > 12.5, P = 0.008) and presence of PSMA metastasis (P = 0.013) were associated with biochemical failure, and corresponding hazard ratios for recurrence within 2 y (4.93 and 3.95, respectively) were similar to or higher than other clinicopathologic prognostic factors. Conclusion: 68Ga-PSMA-11 PET can risk-stratify patients with intermediate- or high-grade prostate cancer before prostatectomy based on degree of uptake in the prostate and presence of metastatic disease.

PD18-11 THE "BUTTERFLY", A NOVEL MINIMALLY INVASIVE TRANSURETHRAL RETRACTION DEVICE FOR BPH

You have accessJournal of UrologyBenign Prostatic Hyperplasia: Surgical Therapy & New Technology III (PD18)1 Sep 2021PD18-11 THE "BUTTERFLY", A NOVEL MINIMALLY INVASIVE TRANSURETHRAL RETRACTION DEVICE FOR BPH Ran Katz, Ali Safadi, Muhamad Abu Ahmed, Shmuel Roizman, Amnon Zisman, Maharan Kabha, Yoram Dekel, Jack Baniel, and shachar Aharoni Ran KatzRan Katz More articles by this author , Ali SafadiAli Safadi More articles by this author , Muhamad Abu AhmedMuhamad Abu Ahmed More articles by this author , Shmuel RoizmanShmuel Roizman More articles by this author , Amnon ZismanAmnon Zisman More articles by this author , Maharan KabhaMaharan Kabha More articles by this author , Yoram DekelYoram Dekel More articles by this author , Jack BanielJack Baniel More articles by this author , and shachar Aharonishachar Aharoni More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002007.11AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The Butterfly Prostatic Retraction Device is a novel minimally invasive, non-surgical implant that is delivered into the prostatic urethra in order to retract the lateral lobes of the prostate, increase the diameter of the prostatic urethra thus treating symptoms associated with BPH. The device is made of nitinol and consists of two lateral wings connected by several transverse rails and is available in five sizes. It is folded into a 5 mm introducer, inserted via rigid cystoscopy and deployed in the prostatic urethra between the verumontanum and the bladder neck. In body temperature the device expands, pushes the prostate lobes laterally, opening a wide path in the prostatic urethra while preserving the bladder neck. It is designed for day surgery or in office settings. We present our results in the management of men suffering from BPH. METHODS: A prospective, Open-Label clinical study for assessing the safety and efficacy of the Butterfly device in male patients suffering from LUTS due to BPH was performed enrolling up to date 50 men who were treated for BPH for at least one year and were candidates for prostatectomy. All patients had Qmax≤ 13 ml/sec and IPSS > 12. Patients with previous prostate procedure, prostatitis, cystolithiasis, prostate median lobe, urethral/bladder neck stricture and atonic bladder were excluded. The study was approved by the hospitals’ IRBs. Insertion of the device was performed under sedation in a day care setting. No catheter was left. Follow up visits were performed at 2 weeks, 1, 3, 6, and 12 months and included uroflowmetry, IPSS, QoL and sexual function questionnaires. Cystoscopy was performed on 3 and 12 months. RESULTS: Patient age range was 50-82 years. 23 patients completed a 1 year follow up and median follow up was 9 months. In one-year Qmax improved by 33%, IPSS score by 40% and QoL score improved by 38% compared to baseline. No patient reported deterioration of sexual function and all sexually active patients reported antegrade ejaculation. On cystoscopy, gradual coverage of the device with urethral mucosa was observed and there were no cases of encrustation. No unanticipated device related AE occurred. In one patient the device was re-positioned. Five patients elected to remove the device and returned to alpha blocker therapy. Seven patients underwent TURP. One patient developed a bulbar urethral stricture. CONCLUSIONS: The butterfly device is simple and efficient minimally invasive device for the management of LUTS due to BPH with a low complication rate, comparable to other minimally invasive devices, and good tolerability. Source of Funding: Butterfly Medical - Yokneam, Israel © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e359-e359 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Ran Katz More articles by this author Ali Safadi More articles by this author Muhamad Abu Ahmed More articles by this author Shmuel Roizman More articles by this author Amnon Zisman More articles by this author Maharan Kabha More articles by this author Yoram Dekel More articles by this author Jack Baniel More articles by this author shachar Aharoni More articles by this author Expand All Advertisement PDF downloadLoading ...

In vivo 3D neuroanatomical evaluation of periprostatic nerve plexus with 3T-MR Diffusion Tensor Imaging

ObjectivesTo evaluate if Diffusion Tensor Imaging technique (DTI) can improve the visualization of periprostatic nerve fibers describing the location and distribution of entire neurovascular plexus around the prostate in patients who are candidates for prostatectomy. Materials and methodsMagnetic Resonance Imaging (MRI), including a 2D T2-weighted FSE sequence in 3 planes, 3D T2-weighted and DTI using 16 gradient directions and b=0 and 1000, was performed on 36 patients. Three out of 36 patients were excluded from the analysis due to poor image quality (blurring N=2, artifact N=1).The study was approved by local ethics committee and all patients gave an informed consent. Images were evaluated by two radiologists with different experience in MRI. DTI images were analyzed qualitatively using dedicated software. Also 2D and 3D T2 images were independently considered. Results3D-DTI allowed description of the entire plexus of the periprostatic nerve fibers in all directions, while 2D and 3D T2 morphological sequences depicted part of the fibers, in a plane by plane analysis of fiber courses. DTI demonstrated in all patients the dispersion of nerve fibers around the prostate on both sides including the significant percentage present in the anterior and anterolateral sectors. ConclusionsDTI offers optimal representation of the widely distributed periprostatic plexus. If validated, it may help guide nerve-sparing radical prostatectomy.

Effect of Transurethral Resection of Prostate on Prostatic Resistive Index

Introduction: In the present study, we evaluated the effect of transurethral resection of the prostate (TUR-P) on prostatic resistive index (RI) in patients with benign prostatic hyperplasia(BPH). Patients and Methods: Forty BPH patients who were candidates for prostatectomy were prospectively included in the study. Prostatic RI was measured using power Doppler imaging (PDI) before TUR-P. In the postoperative follow-up, all patients were reevaluated with PDI, International Prostate Symptom Score (IPSS) and uroflowmetry. Results: Mean age, IPSS and maximal urine flow rate (Q_max) of the patients was 65.8 ± 7.6 years, 24.6 ± 7.1 and 7.7 ± 3.8 ml/s, respectively. The mean prostatic RI of the patients before TUR-P was 0.79 ± 0.02. Prostatic RI positively correlated with total prostate volume and IPSS (r = 0.57, p = 0.0001, and r = 0.42, p = 0.008, respectively) and negatively correlated with Q_max (r = –0.37, p = 0.029) prior to treatment. After TUR-P, mean IPSS and prostatic RI significantly decreased (6.5 ± 4.3 and 0.68 ± 0.03, respectively; p < 0.05), whereas mean Q_max was increased (15.7 ± 5.7, p < 0.05). Conclusions: Our data demonstrated that prostatic RI of the patients with BPH significantly decreased after TUR-P. We believe that prostatic RI could be a useful parameter for the follow-up of patients who underwent TUR-P.

EFFECT OF TRANSURETHRAL RESECTION OF PROSTATE ON PROSTATIC RESISTIVE INDEX

La courbe d’apprentissage du HoLEP est réputée difficile. Nous avons évalué l’intérêt d’un tutorat séquentiel en 3 étapes dans le processus de formation à la procédure au sein d’un centre universitaire.Étude de cohorte monocentrique rétrospective des 82 premières procédures HoLEP effectuées, consécutivement, par le même opérateur ayant suivi une formation spécifique, pratique et théorique, avec un proctoring en début d’expérience puis après 40 cas permettant de répartir les patients en deux groupes. Pour tous les patients, étaient mesurés : vitesse opératoire (g/min), pourcentage d’adénome énucléé (poids énucléé/poids échographique préopératoire), morbidité périopératoire (classification de Clavien), durée d’hospitalisation et de sondage postopératoire et résultats fonctionnels à court terme (débit maximum, résidu post-mictionnel, scores de qualité de vie et IPSS en préop, à 3 et 6 mois).Une amélioration significative des vitesses d’énucléation (0,87 vs 0,56 g/min ; p < 0,0001) et de morcellation (4,2 vs 3,37 g/min, p = 0,038) de même qu’un volume prostatique plus élevé (43,5 vs 68,1 mL, p = 0,0001) ont été observés en deuxième partie d’expérience. Le pourcentage d’adénome énuclée était plus élevé également, bien que la différence ne soit pas significative (69,5 % vs 80,4 %, p = 0,06). Les taux de complication per- et postopératoires, la durée d’hospitalisation (3,7 vs 3,02 jours) et de sondage, et les résultats fonctionnels à 3 et 6 mois n’étaient pas significativement différents.La période d’apprentissage n’a pas influencé les résultats fonctionnels. Une seconde visite d’expert nous a semblé essentielle pour améliorer les performances opératoires. Ces données soulignent l’intérêt d’une réflexion pédagogique pour bâtir une formation à l’HoLEP structurée et standardisée.4.Holmium laser enucleation of prostate (HoLEP) is renowned for the difficulty of its learning curve. Our aim was to evaluate the interest of a three-step tutorial in the HoLEP learning curve, in a university center.It is a retrospective, monocentric study of the 82 first procedures done consecutively by the same operator with a proctoring in early experience and after 40 procedures. For all patients were noted: enucleation efficiency (g/min), morcellation efficiency (g/min), percentage of enucleated tissue (enucleated tissue/adenome weigth evaluated by ultrasonography. g/g), perioperative morbidity (Clavien), length of hospital stay, length of urinary drainage, functional outcomes at short and middle term (Qmax, post-void residual volume [PVR], QOL scores and IPSS at 3 and 6 months).Enucleation and morcellation efficiency were significantly higher after the second proctoring (0.87 vs 0.44 g/min; P < 0.0001 and 4.2 vs 3.37 g/min, P = 0.038, respectively) so as the prostatic volume (43.5 vs 68.1 mL, P = 0.0001). Percentage of enucleated tissue was higher in the second group, however, the difference was not significant (69.5% vs 80.4%, P = 0.03). Per- and postoperative complications, hospital length of stay, urinary drainage length and functional results at 3 and 6 months were not significantly different.The learning curve did not interfere with functional results. The second proctoring was essential to us in order to grasp the technique. These data underlined the necessity of a pedagogic reflexion in order to built a standardized formation technique to the HoLEP.4.

Outcome after radical prostatectomy in young men with or without a family history of prostate cancer

Objectives To establish the cancer control afforded by radical prostatectomy in patients aged 50 years or younger with sporadic, familial, or hereditary prostate cancer. Methods We collected data on all patients 50 years old or younger among 5880 patients treated for prostate cancer between 1994 and 2004. We recorded age, ethnic origin, clinical presentation, family history of prostate cancer, preoperative prostate-specific antigen (PSA) level, treatment, Gleason score, 2002 TNM stage, surgical margin status, and disease progression. Radical prostatectomy was offered as first-line treatment to all patients with localized prostate cancer (T1-T2N0M0) and negative lymph nodes. PSA-free survival was calculated. Results We analyzed the data from 110 patients (1.9%), of whom 37 had familial cancer (33.6%) and 15 hereditary cancer (13.6%). A total of 85 patients (77.3%) had undergone radical prostatectomy, 39 (45.9%) by open retropubic surgery and 46 (54.1%) laparoscopically. The surgical margins were positive in 11 patients (12.9%). The mean follow-up after prostatectomy was 39.1 ± 36.8 months (range 4 to 125). Nine patients (10.6%) experienced biochemical recurrence (PSA level greater than 0.2 ng/mL). Longer PSA-free survival after surgery was significantly associated with high-risk and intermediate-risk patients ( P = 0.01 and P = 0.02, respectively) but not with the surgical procedure ( P = 0.6) or family history of cancer ( P = 0.46). Conclusions Radical prostatectomy is an effective treatment of localized cancer in patients younger than 50 years old. Nearly one half of our cases of prostate cancer in younger men were forms of familial cancer. Detecting familial forms is a key objective in early screening and in the timely identification of candidates for prostatectomy.

OUTCOME AFTER RADICAL PROSTATECTOMY IN YOUNG MEN WITH OR WITHOUT A FAMILY HISTORY OF PROSTATE CANCER

To establish the cancer control afforded by radical prostatectomy in patients aged 50 years or younger with sporadic, familial, or hereditary prostate cancer.We collected data on all patients 50 years old or younger among 5880 patients treated for prostate cancer between 1994 and 2004. We recorded age, ethnic origin, clinical presentation, family history of prostate cancer, preoperative prostate-specific antigen (PSA) level, treatment, Gleason score, 2002 TNM stage, surgical margin status, and disease progression. Radical prostatectomy was offered as first-line treatment to all patients with localized prostate cancer (T1-T2N0M0) and negative lymph nodes. PSA-free survival was calculated.We analyzed the data from 110 patients (1.9%), of whom 37 had familial cancer (33.6%) and 15 hereditary cancer (13.6%). A total of 85 patients (77.3%) had undergone radical prostatectomy, 39 (45.9%) by open retropubic surgery and 46 (54.1%) laparoscopically. The surgical margins were positive in 11 patients (12.9%). The mean follow-up after prostatectomy was 39.1 +/- 36.8 months (range 4 to 125). Nine patients (10.6%) experienced biochemical recurrence (PSA level greater than 0.2 ng/mL). Longer PSA-free survival after surgery was significantly associated with high-risk and intermediate-risk patients (P = 0.01 and P = 0.02, respectively) but not with the surgical procedure (P = 0.6) or family history of cancer (P = 0.46).Radical prostatectomy is an effective treatment of localized cancer in patients younger than 50 years old. Nearly one half of our cases of prostate cancer in younger men were forms of familial cancer. Detecting familial forms is a key objective in early screening and in the timely identification of candidates for prostatectomy.

A Phase I Pharmacokinetic and Pharmacodynamic Study of OGX-011, a 2′-Methoxyethyl Antisense Oligonucleotide to Clusterin, in Patients With Localized Prostate Cancer

Clusterin is a cytoprotective chaperone protein that promotes cell survival and confers broad-spectrum treatment resistance. OGX-011 is a 2'-methoxyethyl modified phosphorothioate antisense oligonucleotide that is complementary to clusterin mRNA and has been reported to inhibit clusterin expression and enhance drug efficacy in xenograft models. The primary objective of this clinical study was to determine a biologically effective dose of OGX-011 that would inhibit clusterin expression in human cancer. Subjects (n = 25) with localized prostate cancer with high-risk features who were candidates for prostatectomy were treated with OGX-011 by 2-hour intravenous infusion on days 1, 3, and 5 and then weekly from days 8-29 combined with androgen blockade starting on day 1; prostatectomy was performed on days 30-36. Six different doses were tested, from 40 to 640 mg. OGX-011 plasma and prostate tissue concentrations were measured by an enzyme-linked immunosorbent assay method, and the pharmacokinetics of OGX-011 were determined from these data. Prostate cancer tissue, lymph nodes, and serial samples of peripheral blood mononuclear cells were assessed for clusterin expression using quantitative real-time polymerase chain reaction and immunohistochemistry. All statistical tests were two-sided. Only grade 1 and 2 toxicities were observed. The plasma half-life of OGX-011 was approximately 2-3 hours, and the area under the concentration versus time curve and CMAX (peak plasma concentration) increased proportionally with dose (Ptrend < .001). OGX-011 in prostate tissue increased with dose (Ptrend < .001). Dose-dependent decreases in prostate cancer and lymph node clusterin expression were observed by polymerase chain reaction of greater than 90% (Ptrend = .008 and Ptrend < .001, respectively) and by immunohistochemistry (Ptrend < .001 and Ptrend = .01, respectively). OGX-011 is well tolerated and reduces clusterin expression in primary prostate tumors. The optimal biologic dose for OGX-011 at the schedule used is 640 mg.

Early diagnosis and monitoring of superficial transitional cell carcinoma by microsatellite analysis on urine sediment

It has recently been shown that allelic abnormalities, detected by microsatellite analysis of the DNA extracted from urine sediment, can be successfully used for the detection of transitional cell carcinoma (TCC) of the bladder. The diagnostic accuracy of urinary cytology, urinary bladder cancer (UBC) marker, bladder tumor antigen (BTA) and microsatellite sequence alterations was compared in 42 patients who were recruited for the study. Of them, 30 had been diagnosed with TCC at cystoscopy plus biopsy (group A). Seven patients without any apparent lesions after trans-urethral resection (TUR) and 6 subsequent weeks of endovesical administration of bacillus Calmette-Guerin (BCG), had irritative symptoms. None of them had positive cytology or TCC bladder mucosa biopsies (group B). In the control group were 5 other subjects who were affected by benign prostatic hypertrophy and candidates for prostatectomy (group C). Urine and blood samples were obtained from all of the patients before surgery. Tumor tissue and normal mucosa samples were taken from groups A and C during surgery. Different urinary sediment analyses were performed by using both nuclear medicine and molecular tests. UBC and BTA-t analyses were carried out using monoclonal antibody tests while microsatellite analyses were performed using extracted DNA and electrophoresis of polymerase chain reaction (PCR) products on 13 different primers. Urinary cytological examinations were carried out using the Autocyte Preparation System(R). Urinary cytology confirmed the presence of TCC in 13.3% of patients. The BTA-t marker allowed the identification of 73.3% of cancers with 50% specificity; the UBC marker identified 63.3% of the cases with 41.6% specificity. Microsatellite analysis permitted the identification of 83.3% of the tumors with 100% specificity. DNA analysis demonstrated high sensitivity in patients affected by superficial (81.4%) or G1 (80%) tumors, even when cytological studies demonstrated little or no sensitivity. Microsatellite analysis is a highly-sensitive and specific marker for TCC diagnosis and its monitoring, especially in patients with low-stage and low-grade tumors. Other testing procedures failed to increase urinary cytological diagnostic significance.

A phase I pharmacokinetic (PK) and pharmacodynamic (PD) study of OGX-011, a 2'methoxyethyl phosphorothioate antisense to clusterin, in patients with prostate cancer prior to radical prostatectomy

3033 Background: The clusterin gene encodes a chaperone protein that promotes cell survival. Clusterin is expressed in a variety of cancers including prostate, increases in response to after androgen abaltion and other apoptotic stimuli, and confers a resistant phenotype in pre-clinical models . OGX-011 (Oncogenex Technologies Inc) is a 2nd generation antisense complimentary to clusterin mRNA that inhibits expression of clusterin in xenograft models and thereby increases sensitivity to therapy. The objective of this first-in-man study was to determine phase II dose based on optimal target regulation effect in addition to standard toxicity parameters. Methods: Patients having localized prostate cancer with high-risk features and candidates for prostatectomy were enrolled to this dose escalation trial. OGX-011 was given by IV infusion over 2 hrs at a starting dose of 40mg on days 1, 3, 5, 8, 15, 22, and 29. Buserelin and flutamide were started on day 1. Prostatectomy was performed day 30–36. OGX-011 plasma PK and prostate tissue concentrations were determined. Prostate tissues, serial samples of peripheral blood mononuclear cells, and serum were assessed for clusterinexpression. Results: 20 patients have been enrolled to 6 cohorts with doses of OGX-011 up to 640mg. Toxicity has been limited to grade 1 or 2, including fevers, rigors, fatigue and transient AST and ALT elevations. Plasma PK analysis showed linear increases in AUC with a t1/2 of approximately 2 hrs. OGX-011 prostate tissue concentrations increased with dose to a mean of 2.30 ug/g (∼300nM) at 480mg dosing. Dose dependent decreases in prostate tumor clusterin expression were observed by immunohistochemistry (IHC) and in situ hybridization. By IHC, mean % cancer cells staining for 0 intensity at 480mg was 49.2% (SE 9.0) compared with 3.3–14.5% for lower dose levels. Conclusions: OGX-011 is well tolerated and can inhibit clusterin expression in prostate cancers. Dose escalation and additional PD assessments continue. Supported by a grant from the U.S. Department of Defense and coordinated by the NCIC-CTG. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration OncoGenex Technologies OncoGenex Technologies OncoGenex Technologies Abbott; Aventis OncoGenex Technologies

The Efficacy and Safety of Perioperative Low Molecular Weight Heparin Substitution in Patients on Chronic Oral Anticoagulant Therapy Undergoing Transurethral Prostatectomy for Bladder Outlet Obstruction

Candidates for prostatectomy who require chronic anticoagulant therapy present a major perioperative management problem due to the threat of significant hemorrhage associated with surgery and the risk of thromboembolism associated with discontinuation of the anticoagulants. We evaluated prospectively a perioperative routine using low molecular weight heparin substitution to allow safe discontinuation of prophylactic oral anticoagulants in patients undergoing transurethral resection of the prostate. We treated 20 patients on chronic oral anticoagulant therapy who required prostatectomy for bladder outlet obstruction according to a prospective protocol based on exchange of the oral anticoagulants with perioperative injections of low molecular weight heparin and resumption of oral anticoagulants early postoperatively. The safety and efficacy of this regimen were assessed in comparison to a control group comprised of 20 randomly selected nonwarfarin treated patients who underwent prostatectomy during the same period. The need for blood transfusions and mean number of units transfused did not significantly differ between the 2 groups. Due to persistent hematuria routine removal of the catheter was possible only in 9 of 20 patients (45%) in the heparin group compared to 18 of 20 (90%) in the control group. Average catheterization and hospitalization period in the heparin group was 3.2 days and 4.2 days respectively, compared to 2.1 and 2.1 days in the control group, respectively (p <0.01). No long-term hemorrhagic or thromboembolic complications were noted at 3 months postoperatively. Despite longer hospitalization in the heparin treated group, our substitution protocol is safe and effective.

Role of systematic ultrasound-guided staging biopsies in predicting extraprostatic extension and seminal vesicle invasion in men with prostate cancer.

To assess the presence of extraprostatic extension and seminal vesicle invasion in men with prostate cancer, we performed systematic staging biopsies targeting neurovascular bundles, seminal vesicles, and other extraprostatic tissues before the men underwent radical prostatectomy. We retrospectively evaluated the clinical efficacy of these systematic staging biopsies compared with digital rectal examination (DRE) and transrectal sonography (TRUS). Two hundred forty-four candidates for prostatectomy who had a diagnostic biopsy Gleason score of 8 or higher and/or indications of extraprostatic extension (eg, seminal vesicle invasion) by DRE or TRUS underwent staging biopsies using an 18-gauge Tru-Cut needle under real-time TRUS guidance between June 1997 and March 2000. We determined the number of staging biopsy cores to be taken based on the Gleason score of the diagnostic biopsy as well as abnormal DRE and/or TRUS findings. The chi-square test was used to evaluate the statistical significance of differences. There were no complications of staging biopsy. In 75 (31%) of the 244 patients, results of the staging biopsies were positive. The clinical stage was upgraded by staging biopsy in 18 (24%) of these 75 patients. After the staging biopsies, 90 patients underwent radical prostatectomy. Among these 90 patients, staging biopsy specimens were positive for cancer in 20 (47%) of the 43 patients who received neoadjuvant therapy and in 1 (2%) of the 47 patients who did not receive neoadjuvant therapy. There were no false-positive staging biopsies in either group. Among the 90 patients who underwent radical prostatectomy, the false-negative rate for the prediction of organ-confined disease was 43% (30/69) for staging biopsies compared with 29% (10/34) for TRUS. The diagnostic accuracy of staging biopsies (67%; 60/90) was higher than that of DRE (52%; 47/90; p < 0.05) but lower than that of TRUS (79%; 71/90; p = 0.066). Staging biopsies can reliably sample extraprostatic tissue, including the seminal vesicles and neurovascular bundles. Positive staging biopsy results can aid in the selection of treatment options and in the prediction of outcome for individual patients by providing definitive histologic confirmation of locally advanced disease. Conventional predictive variables for staging can be applied when the results of staging biopsies are negative.

Criteria for Biopsy Diagnosis of Minimal Volume Prostatic Adenocarcinoma

Abstract Context.—Minimal volume prostatic adenocarcinoma (defined as involving less than 5% of biopsy tissue) is diagnosed increasingly today because of successful cancer screening. We previously described the diagnostic category called atypical small acinar proliferation (ASAP), suspicious for but not diagnostic of malignancy, present in about 2.5% of routine prostatic needle biopsy specimens. Objective.—To establish the criteria enabling a distinction between ASAP and cancer. Design.—We prospectively evaluated clinical and histologic findings from all 319 patients consecutively diagnosed as having ASAP or minimal cancer by prostatic needle biopsy in a consultation service. Seventeen histopathologic features were assessed. Results.—Fifty-six patients (18%) had ASAP, and 100 (31%) had minimal cancer; the remaining 163 (51%) had benign diagnoses, high-grade prostatic intraepithelial neoplasia, or larger amounts of cancer. The mean age of patients with ASAP did not differ from that of patients with minimal cancer (64.2 years vs 63.3 years; P = .65). In 10 of 17 histopathologic findings, ASAP differed significantly from minimal cancer. Among architectural findings, ASAP foci averaged 0.4 vs 0.8 mm (P &amp;lt; .0001) and comprised a mean of 11 vs 17 acini (P &amp;lt; .0001). Infiltrative growth occurred in 75% of ASAP foci and 100% of minimal cancers (P &amp;lt; .0001). Among cytologic findings, ASAP was significantly less likely than cancer to have mitotic figures (0% vs 10%, respectively; P &amp;lt; .01) or prominent nucleoli in at least 10% of cells (55% vs 100%, respectively; P &amp;lt; .0001) and showed more frequent nuclear hyperchromasia (44% vs 9%, respectively; P &amp;lt; .0001) and less nuclear enlargement (P = .0002). Luminal blue mucin secretions were less common in ASAP than cancer (6% vs 33%, respectively; P &amp;lt; .0001), but eosinophilic granular secretions and crystalloids were about equally frequent. Concomitant high-grade prostatic intraepithelial neoplasia was present in 23% of ASAP cases and 57% of cancers (P &amp;lt; .0001). Moderate-to-severe atrophy confounded 59% of cases with ASAP and 35% of cancers (P = .003); both ASAP foci and cancer were associated with inflammation in about a quarter of cases. In each case with ASAP, we stratified our level of suspicion among 3 categories (favor benign, uncertain, and favor carcinoma). As suspicion increased so did the mean nuclear enlargement and percentage of cases with infiltrative growth and nuclear hyperchromasia (all P &amp;lt; .05). Conclusions.—These criteria, which differ significantly between ASAP and minimal volume cancer, can help to separate patients for whom a second biopsy is recommended from candidates for prostatectomy or other therapy.

Limitations of Epidemiologically Based Needs Assessment

The aim of this study was to make epidemiologically based estimates of the prevalent and incident "need" for prostatectomy for lower urinary tract symptoms, defined as the numbers of men who would both benefit from and want the operation. The methods involved a consensus panel, a two-stage postal survey of 1,480 men aged 55 years or older from eight general practices to the northwest of London, United Kingdom, and a multistate life table. The overall response rate was 69% (initial survey: 78%, follow-up survey: 88%). A trial-based estimate of number of candidates for prostatectomy (men with symptoms that were at least moderately severe and bothersome and who would probably or definitely want surgery) was 610 men in a population of 250,000. The corresponding incidence estimate (including men with symptoms recurring after spontaneous remission or surgery) was approximately 200 per year, including approximately 110 new cases. Consensus-based estimation, including categories of patients who have not yet been subject to a trial, gave much higher figures of approximately 3,000, 650, and 200 candidates, respectively. Adding the number of men who said they were "inclined to" choose surgery would almost double these figures. Estimates of need were highly sensitive to choice of indications and assumptions about patients' attitudes toward surgery. Population needs assessment for specific procedures will always involve judgment as well as epidemiological data and modeling.

Transurethral balloon laser thermotherapy for urinary retention in patients with benign prostatic hyperplasia who are at high surgical risk.

Twelve patients with benign prostatic hyperplasia and urinary retention, who were considered to be poor candidates for prostatectomy, were treated by transurethral balloon laser thermotherapy (TUBAL-T). The mean patient age was 78.9 years (range, 66 to 93 years) and the mean duration of bladder catheterization was 11 weeks (range, 2 to 48 weeks). Irradiation into the prostatic tissue was done through 360 degrees with a neodymium: yttrium aluminum garnet (Nd:YAG) laser balloon placed in the prostatic urethra, with pain relief provided by using local topical anesthesia. The total laser dose was from 45,000 to 123,376 J, with an average of 73,089 J. The irradiation time was from 40 to 54 minutes, with an average of 45.2 minutes. Spontaneous voiding became possible in all patients at a mean of 2.8 days (range, 1 to 7 days) after irradiation. The mean catheter-free period was 20.5 months (range, 6 to 34 months), with the longest being 34 months. The international prostatic symptom scores, quality-of-life scores, and peak uroflow rates showed substantial improvement after laser thermotherapy. To date, long-term resumption of spontaneous voiding was successfully achieved in 9 of 12 cases (75%). TUBAL-T is safe and effective alternative for treatment of urinary retention in patients with benign prostatic hyperplasia who are considered to be at high surgical risk.

Association between Symptomatology and Uroflowmetry in Benign Prostatic Hypertrophy

The symptoms of 128 consecutive patients (mean age 65 years) with benign prostatic hypertrophy were assessed and compared with flowmetry recordings. The 84 patients (65%) with peak flow rates greater than or equal to 2 standard deviations from the mean were considered to have abnormal flowmetry and their symptoms were compared with those of the 44 men with normal peak flows. No significant correlation between peak flow rate and age was found within this group. Symptoms of poor stream, nocturia, post-micturition dribble and nocturnal or full-bladder hesitancy were present in over two-thirds of the whole series. Poor stream, hesitancy and nocturnal or full-bladder hesitancy were found to have significant associations with abnormal flowmetry recordings but also to have a high incidence within the normal flowmetry group. Discriminant analysis was unable to define a symptom complex which would accurately predict those within our group with abnormal peak flows. It was concluded that symptomatology and flowmetry evidence of lower urinary tract obstruction are not associated and subjective and objective evidence must be considered independently in selecting candidates for prostatectomy.