Absence Of Clinical Recurrence Research Articles

Perioperative outcomes and continence following robotic-assisted radical cystectomy with mainz pouch II urinary diversion in patients with bladder cancer

PurposeTo present the widely unknown perioperative outcomes and continence status of bladder cancer patients following robotic-assisted radical cystectomy (RARC) with Mainz pouch II urinary diversion (UD).Materials and methodsFrom November 2020 to December 2023, 37 bladder cancer patients who underwent RARC with Mainz pouch II UD were retrospectively assessed (ChiCTR2300070279). The results, which included patient demographics, perioperative data, continence, and complications (early ≤ 30 days and late ≤ 30 days) were reported using the RC-pentafecta criteria. RC-pentafecta criteria included ≥ 16 lymph nodes removed, negative soft tissue surgical margins, absence of major (Grade III–IV) complication at 90 days, absence of clinical recurrence at ≤ 12 months, and absence of long-term UD-related sequelae. A numeric rating scale assessed patient satisfaction with urinary continence 30 days after surgery. The validated Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire was used to evaluate bowel function. The Kaplan-Meier curve was used to evaluate overall survival (OS).ResultsOf the 37 patients evaluated over a median (range) follow-up period of 23.0 (12.0-36.5) months. The median (range) age was 65 (40–81) years. The median (range) time to urinary continence after surgery was 2.3 (1.5-6) months. Of the 37 patients, 31 (83.8%) were continent both during the day and at night, 34 (91.9%) were continent during the day, 32 (86.5%) were continent at night, 35 (94.6%) were satisfied with their urinary continence status, and 21 (56.8%) were very satisfied. The mean (range) voiding frequency was 6 (4–10) during the day and 3 (2-5.5) at night. The mean (range) PAC-SYM total score was 9.50 (4.00–15.00). In 12 (32.4%) of the patients, RC-pentafecta was achieved, and achieving RC-pentafecta was linked to better satisfaction scores (7.3 vs. 5.5, p = 0.034). There was no significant difference between RC-pentafecta and No RC-pentafecta groups in terms of OS (25.6 vs. 21.5 months, p = 0.16). 7 (19.4%) patients experienced late complications.ConclusionsMainz pouch II UD following RARC in bladder cancer patients results in a satisfactory continence rate. Achieving RC-pentafecta was correlated with better satisfaction scores. The intracorporeal approach to Mainz pouch II UD is beneficial for female patients due to its reduced invasiveness.Trial registrationChiCTR2300070279; Registration: 07/04/2023, Last updated version: 01/06/2023. Retrospectively registered.

Robot-assisted vesicovaginal fistula repair: comparison of the extravesical and transvesical techniques.

Almost two decades after the description of robotic vesicovaginal fistula repair (R-VVF), the literature remains limited. The aims of this study are to report the outcomes of R-VVF and to compare the transvesical versus extravesical techniques. We performed an observational, retrospective, multicenter study, including all patients who underwent R-VVF from March 2017 to September 2021 at four academic institutions. All abdominal VVF repair over the study period were performed using a robotic approach. The success of R-VVF was defined as the absence of clinical recurrence. The outcomes of the extravesical versus transvesical techniques were compared. Twenty-two patients were included. The median age was 43 years old (IQR 38-50). Fistulas were supratrigonal and trigonal in 18 and 4 cases respectively. Five patients had undergone previous attempts of fistula repair (22.7%). The fistulous tract was systematically excised, and an interposition flap was used in all but two cases (90.9%). The transvesical and extravesical techniques were used in 13 and 9 cases respectively. There were four postoperative complications, three minor and one major. None of the patients had vesicovaginal fistula recurrence after a median follow-up of 15 months. The present series, one of the largest R-VVF reported to date, is consistent with the few series already published with a 100% cure rate. Systematic excision of the fistulous tract and the high rate of flap interposition may explain the high success rate. The transvesical and extravesical approaches yielded similar outcomes.

MP42-18 ROBOT-ASSISTED VESICO-VAGINAL FISTULA REPAIR: COMPARISON OF THE EXTRAVESICAL AND TRANSVESICAL TECHNIQUES

You have accessJournal of UrologyCME1 Apr 2023MP42-18 ROBOT-ASSISTED VESICO-VAGINAL FISTULA REPAIR: COMPARISON OF THE EXTRAVESICAL AND TRANSVESICAL TECHNIQUES Pierre Lecoanet, Thibault Tricard, Anne Mauger De Varennes, Camille Haudebert, Juliette Hascoet, Nicolas Hubert, Imad Bentellis, Branwell Tibi, Christian Saussine, Jacques Hubert, and Benoit Peyronnet Pierre LecoanetPierre Lecoanet More articles by this author , Thibault TricardThibault Tricard More articles by this author , Anne Mauger De VarennesAnne Mauger De Varennes More articles by this author , Camille HaudebertCamille Haudebert More articles by this author , Juliette HascoetJuliette Hascoet More articles by this author , Nicolas HubertNicolas Hubert More articles by this author , Imad BentellisImad Bentellis More articles by this author , Branwell TibiBranwell Tibi More articles by this author , Christian SaussineChristian Saussine More articles by this author , Jacques HubertJacques Hubert More articles by this author , and Benoit PeyronnetBenoit Peyronnet More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003280.18AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Robotic vesico-vaginal fistula repair (R-VVF) was described in 2004 with the aim to minimize the morbidity of the abdominal VVF repair. Almost two decades later, the literature on r-VVF remains scant. The objective of this study was to evaluate the results of R-VVF repaisr and to report complications. METHODS: The charts of all female patients who underwent a R-VVF from March 2007 to December 2021 at four academic institutions were reviewed retrospectively. All surgeons involved had already a robust robotic surgery experience at the beginning experience (>50 cases) but limited experience with VVF repair. All abdominal VVF repair over the study period were performed using a robotic approach. All centers used a vaginal approach in case of easily accessible vaginal fistulous orifice. The decision to use a vaginal or an abdominal approach was not standardized across centers and left at the surgeons’ discretion. The patients’ characteristics, the surgical technique details (iflap interposition vs. not, transvesical versus extravesical approach, excision of fistulous tract vs not) and peri-operative outcomes were recorded. The success of VVF-R was defined as the absence of clinical recurrence. The outcomes of the extravesical vs transvesical techniques were compared. RESULTS: Twenty-two patients were included over the study period. The median age was 43 years (IQR 38-50). The causes of VVF-R were either post-surgical (77.3%), post-obstetrical (18.2%) or post-trauma (4.5%). Fistulas were supratrigonal and trigonal in 18 and 4 cases respectively. The fistulous tract was systematically excised and an interposition flap was used all but two cases (90.9%%). The transvesical and extravesical techniques were used in 13 and 9 cases respectively. The patient andfistula’s characteristics are presented in Table 1. There were more supratrigonal fistula in the extravesical group (100% vs. 69.2%; p=0.11). One intraoperative complication occurred in the extravesical group: an ureteral injury which was immediately sutured (11.1% vs. 0%; p=0.41). The operative time tended to be shorter in the extravesical group (179 vs. 229 minutes; p=0.13). There were only three postoperative complications, all minor: one gross hematuria in the extravesical group (Clavien grade 1), one hematoma requiring blood transfusion and one pyelonephritis in the transvesical group (both Clavien grade 2) (11.1% vs. 15.4%; p=0.99). The length f hospital stay did not differ significantly between the to groups (5.1 vs. 4.1 dys; p=0.56). None of the patients had vesico-vaginal fistula recurrence after a median follow-up of 14 months (IQR 3-21). CONCLUSIONS: The present series, one of the largest R-VVF reported to date, is consistent with the few series already published with a 100% cure rate and excellent perioperative outcomes. Systematic excision of the fistulous tract and the high rate of flap interposition may explain the high success rate. The transvesical and extravesical approach yielded similar outcomes but the transvesical approach may allow to treat more complex fistulas (e.g. infratrigonal). Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e575 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Pierre Lecoanet More articles by this author Thibault Tricard More articles by this author Anne Mauger De Varennes More articles by this author Camille Haudebert More articles by this author Juliette Hascoet More articles by this author Nicolas Hubert More articles by this author Imad Bentellis More articles by this author Branwell Tibi More articles by this author Christian Saussine More articles by this author Jacques Hubert More articles by this author Benoit Peyronnet More articles by this author Expand All Advertisement PDF downloadLoading ...

Assessing pentafecta achievement after robot-assisted radical cystectomy and its association with surgical experience: Results from a high-volume institution.

Radical cystectomy (RC) represents the gold standard treatment for high-risk bladder cancer. Despite evidence suggesting that surgical experience correlates with perioperative and oncologic outcomes of robot-assisted RC (RARC), validated tools to assess its quality objectively are lacking. We aimed to evaluate the impact of RC-Pentafecta (absence of early major complications, absence of urinary diversion related sequelae at ≤12 months, absence of soft tissue surgical margins, ≥16 lymph nodes at final pathology and absence of clinical recurrence at ≤12 months) on oncological outcomes and the role of surgical experience on its achievement. We retrospectively evaluated 366 patients undergoing RARC with intracorporeal urinary diversion in a single tertiary centre with a minimum of 1 year follow-up. Surgeries were performed using the DaVinci Xi system according to a previously described technique. Kaplan-Meier curves were used to investigate 5-years overall survival and cancer specific mortality-free survival (CSS) according to RC-Pentafecta achievement. Multivariable Cox's regressions were performed to evaluate the impact of RC-Pentafecta on overall mortality. Multivariable logistic regressions were performed to explore the effect of surgical experience on RC-pentafecta achievement. Locally weighted scatterplot smoother function was used to graphically explore this relationship. Patients achieving RC-Pentafecta showed higher 5-year overall survival (71.8% vs. 59.6%, P < 0.001) and CSS (84% vs. 71%, P < 0.001) when compared with patients not achieving it. At multivariable Cox's regression, RC-Pentafecta achievement (HR 0.57, P = 0.03), positive surgical margins (HR 2.48, P = 0.002), pN+ (HR 2.23, P = 0.002), pT≥3 (HR 1.71, P = 0.04) and current smoking status (HR 2.4, P = 0.006) were significant predictors of overall mortality. At multivariable logistic regression surgical experience (OR 1.2, P < 0.001), age (OR 0.93, P = 0.04), previous prostate surgery (OR 0.7, P = 0.02) and pT≥3 (OR 0.8, P = 0.03) were independent predictors of RC-Pentafecta achievement. A linear relationship between surgical experience and RC-Pentafecta achievement, without reaching a plateau, was observed. RC-Pentafecta is a valuable tool to assess surgical quality of RARC and the experience of the center where the surgery is performed and may be used to identify "referral" centers for treatment of high-risk bladder cancer.

Radium-223 in patients with prostate specific antigen (PSA) progression and without clinical metastases following maximal local therapy: A pilot study.

Despite the curative intent of radical prostatectomy (RP) (+/- radiotherapy (RT)), 30% of the clinically localized prostate cancer (CaP) patients will develop rising PSA (prostate specific antigen). In absence of clinical recurrence, there is a lack of effective treatment strategies in order to control the disease at its earliest (micro)metastatic stage. The aim of this study was to assess safety, tolerability, and biochemical response of off-label Radium-223 (Xofigo) treatment in CaP patients with PSA relapse following maximal local therapy. We conducted a prospective, single arm, single center open-label, pilot study with Radium-223 in CaP patients with rising PSA (>0.2 ng/ml) following RP + adjuvant/salvage RT. Negative staging with 68Ga-PSMA-11 PET/CT and whole-body MRI was mandatory at time of inclusion. Patients were eligible if they exhibited adverse clinico-pathological features predictive of significant recurrence. Safety, tolerability, biochemical progression (defined as PSA increase >50% from PSA nadir) and clinical recurrence were assessed. In total, 23 patients were screened of whom 8 patients were included is the study. Radium-223 treatment was safe with no serious treatment related adverse events. One patient developed grade 3 lymphopenia. All patients rapidly developed PSA progression (median PSA progression-free survival: 5.5 months). Eventually all patients experienced clinical recurrence (median clinical recurrence-free survival 11.0 months) of whom only 2 patients developed skeletal recurrence. Radium-223 in patients with PSA relapse following maximal local treatment without clinical metastases is safe. However, the clinical benefit of Ra-223 in this setting is doubtful as significant oncological benefit is lacking.

Predictors and survival benefit of achieving pentafecta in a contemporary series of open radical cystectomy.

Pentafecta provides a comprehensive approach for standardized reporting of surgical and oncologic outcomes after radical cystectomy and urinary diversion. We aimed to report the rate, predictors of achieving pentafecta and its impact on long-term survival in a contemporary series of open radical cystectomy (ORC). A retrospective analysis of a computerized database of patients treated with ORC between 2004 till 2014 was performed. Pentafecta criteria included negative soft tissue surgical margin (STSM), retrieval of ≥16 lymph nodes, absence of clinical recurrence within 12 months after surgery, absence of high-grade complication (GIII-V) within 90 days after surgery, and absence of urinary diversion related complications at 12 months follow-up. Multivariate analysis was used to identify predictors of achieving pentafecta. Pentafecta was achieved in 545 (33.6%) patients out of 1624 included in the study. Absence of ≥16 LN yield was the first cause of missing pentafecta (49.5%). Multivariate analysis identified: ASA Score grades ≥III (OR=0.7, 95%CI 0.6-0.9, P=0.04), BMI≥35 (OR=0.5, 95%CI 0.3-0.8, P=0.007), perioperative blood transfusion (≥4 units) (OR=0.5, 95%CI 0.3-0.7, P=0.001), and ileal conduit (OR=0.7, 95%CI 0.5-0.9, P= 0.01) as independent predictors of missing pentafecta. Patients who achieved pentafecta had higher estimated 5-year RFS than their counterparts (81.7% vs. 62.5%; P<0.0001). Pentafecta was achieved in nearly one third of patients after ORC. Achievement of pentafecta was associated with better long-term recurrence-free survival. Obesity (class II, III), perioperative blood transfusion (>4 units), associated comorbidities, and ileal conduit were independent predictors of missing pentafecta.

The potential of tumour microenvironment markers to stratify the risk of recurrence in prostate cancer patients

The tumour micro-environment (TME) plays a crucial role in the onset and progression of prostate cancer (PCa). Here we studied the potential of a selected panel of TME-markers to predict clinical recurrence (CLR) in PCa. Patient cohorts were matched for the presence or absence of CLR 5 years post-prostatectomy. Tissue micro-arrays (TMA) were composed with both prostate non-tumour (PNT) and PCa tissue and subsequently processed for immunohistochemistry (IHC). The IHC panel included markers for cancer activated fibroblasts (CAFs), blood vessels and steroid hormone receptors ((SHR): androgen receptor (AR), progesterone receptor (PR) and estrogen receptor (ER)). Stained slides were digitalised, selectively annotated and analysed for percentage of marker expression with standardized and validated image analysis algorithms. A univariable analysis identified several TME markers with significant impact on CR: expression of CD31 (vascular marker) in PNT stroma, expression of alpha smooth muscle actin (αSMA) in PCa stroma, and PR expression ratio between PCa stroma and PNT stroma. A multivariable model, which included CD31 expression (vascular marker) in PNT stroma and PR expression ratio between PCa stroma and PNT stroma, could significantly stratify patients for CLR, with the identification of a low risk and high-risk subgroup. If validated and confirmed in an independent prospective series, this subgroup might have clinical potential for PCa patient stratification.

Radical cystectomy pentafecta: a proposal for standardisation of outcomes reporting following robot-assisted radical cystectomy.

To propose a standardisable composite method for reporting outcomes of radical cystectomy (RC) that incorporates both perioperative morbidity and oncological adequacy. From July 2010 to December 2017, 277 consecutive patients who underwent robot-assisted RC with intracorporeal urinary diversion (UD) for bladder cancer at our Institution were prospectively analysed. Patients who simultaneously demonstrated negative soft tissue surgical margins (STSMs), ≥16 lymph node (LN) yield, absence of major (grade III-IV) complications at 90days, absence of UD-related long-term sequelae and absence of clinical recurrence at ≤12months, were considered as having achieved the RC-pentafecta. A multivariable logistic regression model was assessed to measure predictors for achieving RC-pentafecta. Since 2010, 270 of 277 patients that had completed at least 12months of follow-up were included. Over a mean follow-up of 22.3months, ≥16 LN yield, negative STSMs, absence of major complications at 90days, and absence of UD-related surgical sequelae and clinical recurrence at ≤12months were observed in 93.0%, 98.9%, 76.7%, 81.5% and 92.2%, patients, respectively, resulting in a RC-pentafecta rate of 53.3%. Multivariable logistic regression analysis revealed age (odds ratio [OR] 0.95; P=0.002), type of UD (OR 2.19; P=0.01) and pN stage (OR 0.48; P=0.03) as independent predictors for achieving RC-pentafecta. We present a RC-pentafecta as a standardisable composite endpoint that incorporates perioperative morbidity and oncological adequacy as a potential tool to assess quality of RC. This tool may be useful for assessing the learning curve and calculating cost-effectiveness amongst others but needs to be externally validated in future studies.

MP32-12 RADICAL CYSTECTOMY PENTAFECTA: A PROPOSAL FOR STANDARDIZATION OF OUTCOMES REPORTING FOLLOWING ROBOT ASSISTED RADICAL CYSTECTOMY

INTRODUCTION AND OBJECTIVES:To propose a standardisable composite method for reporting outcomes of radical cystectomy (RC) that incorporates both peri-operative morbidity and oncologic adequacy.METHODS:From July 2010 through December 2017, 277 consecutive patients who underwent robotic radical cystectomy (RRC) for bladder cancer at our institution were prospectively analysed. IRB approval was obtained (HS-01B014). Patients who simultaneously demonstrated negative soft tissue surgical margins, =/> 16 lymph node yield, absence of major (Clavien-Dindo grade III-IV) complications at 90 days, absence of urinary diversion (UD) related long-term sequelae and absence of clinical recurrence at =/< 12 mo. were considered as having achieved the RC-pentafecta. We created a multivariable logistic regression model using age, ASA score, type of UD, NACH, pT and pN stage as covariates to measure independent factors for achieving RC-pentafecta. The internal validity of the prediction model was assessed by 1,000 bootstrap ...

Outcomes of long-pulsed 1064 nm Nd:YAG laser treatment of basal cell carcinoma: A retrospective review.

Recent prospective trials have supported treatment of nonfacial BCC with long-pulsed 1064 nm Nd:YAG laser based on short-term histologic clearance rates. Studies have yet to identify the long-term clinical clearance rates of this specific laser therapy for BCC. This is a retrospective review of BCC treated with long-pulsed 1064 nm Nd:YAG laser, which have been clinically monitored for at least 6 months, to assess for recurrence and cosmetic outcomes of the treated area. 16 BCC lesions (11 subjects) treated with 1064 nm Nd:YAG laser were enrolled. Our analysis revealed 100% clearance rate in all subjects (16 of 16 BCC) treated with long-pulsed Nd:YAG laser based on mean follow-up of 9 months (range 6-15 months). Minimal scarring and no long-term adverse events were noted. This study supports the use of 1064 nm Nd:YAG laser as a therapeutic modality for BCC based on the absence of clinical recurrence upon a mean follow-up of 9 months. As studies progress, we are beginning to observe a potential role for laser as an alternative to patients who refuse surgery, have multiple co-morbidities, or decline non-surgical therapies. Laser treatment with 1064 nm Nd:YAG is an evolving, promising story that we continue to investigate to optimize parameters. Lasers Surg. Med. 51:34-39, 2019. © 2018 Wiley Periodicals, Inc.

Neonatal vs Delayed-Onset Fourth Branchial Pouch Anomalies

To determine the presentation of third or fourth branchial pouch anomalies in various age groups of children and evaluate endoscopic cauterization as a treatment technique. Retrospective study of patients treated from 2000 to 2009. Tertiary care children's hospital. Pediatric patients aged 0 to 18 years (mean age, 5.5 years), including 5 neonates. Endoscopic and/or open surgical management of third and fourth branchial pouch anomalies; clinical and endoscopic follow-up. Absence of clinical recurrence; closure of the sinus tract. Two forms of presentation were identified: a neonatal form, characterized by a voluminous and compressive cervical mass (5 of 20 [25%]) and a childhood form, presenting as a cervical abscess (15 of 20 [75%]). The vast majority of our patients regardless of presentation were treated endoscopically (n=19), with a success rate of 68% (13 of 19) after 1 procedure, 79% (15 of 19) after 2 procedures, and 89% (17 of 19) after 3 procedures. Neonatal and adult presentations require slightly different therapeutic approaches. Third and fourth branchial pouch anomalies can present in 2 distinct forms: a neonatal form and a childhood form. The endoscopic technique should be the favored approach for both forms: whenever possible, in view of its simplicity, rapidity, and the lack of serious postoperative complications. Recurrences can be treated by repeated cauterization using the same technique, with good long-term outcomes. An age-based management algorithm has been developed.

Percutaneous closure of patent foramen ovale: head-to-head comparison of two different devices.

Percutaneous closure of patent foramen ovale (PFO) has been proposed as the treatment of choice for young high-risk patients who suffered cryptogenic stroke and/or peripheral paradoxical embolism. We sought to compare prospectively two different devices used for percutaneous PFO closure.Prospective data were collected on 40 high risk patients (females: 38%, mean age : 44 +/- 11 years, interatrial septal aneurysm >10 mm: 68%) who underwent percutaneous PFO closure after cryptogenic stroke (n = 38) or peripheral paradoxical embolism (n = 2). Chronologically, 20 patients were first treated by a PFO-Star (Cardia, Burnsville, MI) device. Then, 20 other patients received a Starflex occluder (NMT, Boston, MA). The primary endpoint was complete PFO closure at 6 months as assessed by transthoracic contrast echocardiography. Secondary endpoints were major peri- or post procedural complications and clinical recurrence at 1 year follow-up.Baseline clinical and anatomical characteristics were comparable for both groups. Complete PFO closure was observed in 50% (PFO-Star) and 90% (Starflex) of patients (p=0.001) respectively. Major peri-procedural complications occurred in the PFO-star group only: right-sided device thrombus (1 patient) and aorto-right atrial fistula (1 patient). At 1 year follow-up, no clinical recurrence occurred.In conclusion, despite the absence of clinical recurrence in this high-risk population with presumed paradoxical embolism, complete PFO closure at 6 months follow-up was significantly related to the type of closure device used.

Clinical relevance of trans-rectal ultrasound, biopsy, and serum prostate-specific antigen following external beam radiotherapy for carcinoma of the prostate

Purpose : To correlate the results of routine transrectal ultrasound-guided prostate biopsies with the usual clinical parameters of digital rectal examination, prostate specific antigen and ultrasound in the follow-up of one hundred patients treated with radical radiotherapy for prostate cancer. Methods and Materials : Stage distribution of the 100 patients was Tlb: 19, T2a: 24, T2b: 36, T3: 20, T4: 1. Median follow-up is 26 months (range 15–48). One hundred forty-one ultrasound-guided biopsies have been performed with four to seven specimens at each examination. Initial biopsy was scheduled 12 months after radiotherapy and repeated every 6 months until negative or until there was clinical or biochemical evidence of recurrence. Results : Negative biopsies were obtained at 12 months (range 9–15) in only 52%. Of 31 patients with a positive first biopsy who have had a second or third examination, 21 converted to negative at 16–29 months (median: 19) (stage T1b: 3, T2a: 6, T2b: 8, T3: 4). All 21 patients had maintained a normal or decreasing prostate specific antigen (PSA). At last review, negative biopsies had been obtained in 74% of patients: 79% ( 15 19 ) of T1b, 71% ( 17 24 ) of T2a, 72% ( 26 36 ) of T2b, and 76% ( 16 21 ) of T3/4. No patient with a negative biopsy has had a local recurrence. Transrectal ultrasound alone (sens: 49%, spec: 57%) was no better than rectal exam (sens: 73%, spec: 66%) in predicting a positive post radiotherapy biopsy. Metastatic disease developed in seven patients, 12% ( 3 26 ) of those wiht a positive biopsy and 5% ( 4 74 ) of those with a negative biopsy ( p < 0.01). All seven presented first with a rising PSA. Conclusion : For patients with a positive biopsy 12 to 24 months after radiotherapy, PSA is the best indicator of biologically active tumor. This preliminary analysis indicates that there may be no need to treat patients with a positive biopsy and negative PSA in the absence of clinical recurrence.