Update of the Standard Operating Procedure on the Use of Multiparametric Magnetic Resonance Imaging for the Diagnosis, Staging and Management of Prostate Cancer.

PURPOSE: We update the prior standard operating procedure for magnetic resonance imaging of the prostate, and summarize the available data about the technique and clinical use for the diagnosis and management of prostate cancer. This update includes practical recommendations on the use of magnetic resonance imaging for screening, diagnosis, staging, treatment and surveillance of prostate cancer. MATERIALS AND METHODS: A panel of clinicians from the American Urological Association and Society of Abdominal Radiology with expertise in the diagnosis and management of prostate cancer evaluated the current published literature on the use and technique of magnetic resonance imaging for this disease. When adequate studies were available for analysis, recommendations were made on the basis of data and when adequate studies were not available, recommendations were made on the basis of expert consensus. RESULTS: Prostate magnetic resonance imaging should be performed according to technical specifications and standards, and interpreted according to standard reporting. Data support its use in men with a previous negative biopsy and ongoing concerns about increased risk of prostate cancer. Sufficient data now exist to support the recommendation of magnetic resonance imaging before prostate biopsy in all men who have no history of biopsy. Currently, the evidence is insufficient to recommend magnetic resonance imaging for screening, staging or surveillance of prostate cancer. CONCLUSIONS: Use of prostate magnetic resonance imaging in the risk stratification, diagnosis and treatment pathway of men with prostate cancer is expanding. When quality prostate imaging is obtained, current evidence now supports its use in men at risk of harboring prostate cancer and who have not undergone a previous biopsy, as well as in men with an increasing prostate specific antigen following an initial negative standard prostate biopsy procedure.

AUA Policy Statement on the Use of Multiparametric Magnetic Resonance Imaging in the Diagnosis, Staging and Management of Prostate Cancer.

PURPOSE: We summarize the available data about the clinical and economic effectiveness of magnetic resonance imaging in the diagnosis and management of prostate cancer, and provide practical recommendations for its use in the screening, diagnosis, staging and surveillance of prostate cancer. MATERIALS AND METHODS: A panel of clinicians with expertise in the diagnosis and management of prostate cancer evaluated the current published literature on the use and effectiveness of magnetic resonance imaging for this disease. When adequate studies were available for analysis, recommendations were made on the basis of data and when adequate studies were not available, recommendations were made on the basis of expert consensus. RESULTS: At this time the data support the use of magnetic resonance imaging in patients with a previous negative biopsy and ongoing concerns about increased risk of prostate cancer. The data regarding its usefulness for initial biopsy suggest a possible role for magnetic resonance imaging in some circumstances. There is currently insufficient evidence to recommend magnetic resonance imaging for screening, staging or surveillance of prostate cancer. CONCLUSIONS: Although it adds cost to the management of prostate cancer, magnetic resonance imaging offers superior anatomic detail, and the ability to evaluate cellular density based on water diffusion and blood flow based on contrast enhancement. Imaging targeted biopsy may increase the diagnosis of clinically significant cancers by identifying specific lesions not visible on conventional ultrasound. The clinical indications for the use of magnetic resonance imaging in the management of prostate cancer are rapidly evolving.

Five year results of the prospective randomized controlled prostatic urethral L.I.F.T. study.

INTRODUCTION: To report the five year results of a prospective, multi-center, randomized, blinded sham control trial of the Prostatic Urethral Lift (PUL) in men with bothersome lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). MATERIALS AND METHODS: At 19 centers in North America and Australia, 206 subjects ≥ 50 years old with International Prostate Symptom Score (IPSS ) > 12, peak flow rate (Qmax) ≤ 12 mL/s, and prostate volume 30 cc-80 cc were randomized 2:1 to the PUL procedure or blinded sham control. In PUL permanent UroLift implants are placed to hold open the lateral lobes of the prostate to reduce urinary obstruction. After randomized comparison at 3 months and the only opportunity to add more PUL implants, PUL patients were followed to 5 years. LUTS severity (IPSS), quality of life (QOL), BPH Impact Index (BPHII), Qmax, sexual function, and adverse events were assessed throughout follow up. RESULTS: IPSS improvement after PUL was 88% greater than that of sham at 3 months. LUTS and QOL were significantly improved by 2 weeks with return to preoperative physical activity within 8.6 days. Improvement in IPSS, QOL, BPHII, and Qmax were durable through 5 years with improvements of 36%, 50%, 52%, and 44% respectively. No difference was seen between Intent to Treat and Per Protocol populations. Surgical retreatment was 13.6% over 5 years. Adverse events were mild to moderate and transient. Sexual function was stable over 5 years with no de novo, sustained erectile or ejaculatory dysfunction. CONCLUSIONS: PUL offers rapid improvement in symptoms, QOL and flow rate that is durable to 5 years. These improvements were achieved with minimal use of a postoperative urinary catheter, rapid return to normal, and preservation of both erectile and ejaculatory function. Symptom improvement was commensurate with patient satisfaction. PUL offers a minimally invasive option in the treatment of LUTS due to BPH.

Prostatic urethral lift: a novel approach for managing symptomatic BPH in the aging man.

INTRODUCTION: Benign prostatic hyperplasia (BPH) is an obligate disorder of the aging male prostate with close associations to other metabolic conditions of aging including obesity. Clinical manifestations of this chronic disorder increase as men age suggesting that a growing number of older men will require intervention for progressive voiding symptoms or bladder dysfunction. MATERIALS AND METHODS: The Prostatic Urethral Lift (PUL) procedure represents a new endoscopic approach in which small permanent intraprostatic implants are positioned to correct bladder outlet obstruction without tissue destruction. An overview of the treatment modality, review of recent literature, and analysis of data in the context of cost considerations is presented. RESULTS: The mean symptom score improvement of the prospective, sham controlled, pivotal trial was 11 points, 88% greater than sham controls. Multiple studies have confirmed symptom score improvement of at least 52%. Durability has been established out to 3 years. A randomized comparison between PUL and transurethral resection of the prostate (TURP) established PUL as superior to TURP in terms of a composite BPH6 endpoint which incorporated symptom relief, quality of recovery, erectile function preservation, ejaculatory function preservation, continence preservation, and safety. The National Institute for Health and Care Excellence of the United Kingdom conducted an analysis that found PUL is less costly than TURP. Earlier management with PUL may even reduce overall cost for those patients managed with medication. CONCLUSION: Current reports have demonstrated rapid voiding symptom improvement with a low risk of adverse events suggesting that this procedure represents a safe and cost effective new paradigm for the early therapy for BPH/ LUTS.

Three year results of the prostatic urethral L.I.F.T. study.

INTRODUCTION: To report the three year results of a multi-center, randomized, patient and outcome assessor blinded trial of the Prostatic Urethral Lift (PUL) in men with bothersome lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). MATERIALS AND METHODS: At 19 centers in North America and Australia, 206 subjects = 50 years old with International Prostate Symptom Score (IPSS) ≥ 13, peak flow rate (Qmax) ≤ 12 mL/s, and prostate volume between 30 cc-80 cc were randomized 2:1 to the PUL procedure or sham control. PUL involved placing permanent UroLift implants into the lateral lobes of the prostate to enlarge the urethral lumen. After randomized comparison at 3 months, PUL patients were followed to 3 years. LUTS severity (IPSS), quality of life, Qmax, sexual function, and adverse events were assessed throughout follow up. RESULTS: The therapeutic effect of PUL regarding IPSS was 88% greater than sham at 3 months. Average improvements from baseline through 3 years were significant for total IPSS (41.1%), quality of life (48.8%), Qmax (53.1%), and individual IPSS symptoms. Symptomatic improvement was independent of prostate size. There were no de novo, sustained ejaculatory or erectile dysfunction events and all sexual function assessments showed average stability or improvement after PUL. Fifteen of the 140 patients originally randomized to PUL required surgical reintervention for treatment failure within the first 3 years. CONCLUSIONS: PUL offers rapid improvement in voiding and storage symptoms, quality of life and flow rate that is durable to 3 years. Patients demonstrated a level of symptom relief that is associated with significant patient satisfaction. PUL, a minimally invasive procedure, is very effective in treating bothersome LUTS secondary to benign prostatic obstruction (BPO) and is unique in its ability to preserve total sexual function while offering a rapid return to normal physical activities.

Treatment of LUTS secondary to BPH while preserving sexual function: randomized controlled study of prostatic urethral lift.

INTRODUCTION: We analyzed data obtained from a randomized controlled blinded study of the prostatic urethral lift (PUL) to evaluate the sexual side effects of this novel treatment. AIMS: We sought to determine whether PUL, when conducted in a randomized study, significantly improved lower urinary tract symptoms (LUTS) and urinary flow rate while preserving sexual function. METHODS: Men ≥50 years with prostates 30-80 cc, International Prostate Symptom Score (IPSS) >12, and peak urinary flow rate (Qmax) ≤12 ml/s were randomized 2:1 between PUL and sham. Sexual activity was not an inclusion criterion. In PUL, permanent transprostatic implants are placed to retract encroaching lateral lobes and open the prostatic fossa. Sham entailed rigid cystoscopy with sounds to mimic PUL and a blinding screen. MAIN OUTCOME MEASURES: Blinded groups were compared at 3 months and active arm then followed to 12 months for LUTS with IPSS and for sexual function with sexual health inventory for men (SHIM) and Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD). Subjects were censored from primary sexual function analysis if they had baseline SHIM < 5 at enrollment. Secondary stratified analysis by erectile dysfunction (ED) severity was conducted. RESULTS: There was no evidence of degradation in erectile or ejaculatory function after PUL. SHIM and MSHQ-EjD scores were not different from control at 3 months but were modestly improved and statistically different from baseline at 1 year. Ejaculatory bother score was most improved with a 40% improvement over baseline. Twelve-month SHIM was significantly improved from baseline for men entering the study with severe ED, P = 0.016. IPSS and Qmax were significantly superior to both control at 3 months and baseline at 1 year. There was no instance of de novo sustained anejaculation or ED over the course of the study. CONCLUSIONS: The PUL improves LUTS and urinary flow while preserving erectile and ejaculatory function.

Pelvic ultrasound evaluation for benign prostatic hyperplasia: prediction of obstruction.

Global improvements in water quality, management of infectious diseases, and other medical therapeutics have resulted in a growing population of healthy aging men. One obligate anatomic consequence of aging for these men is the development of benign prostatic hyperplasia (BPH) with secondary bladder outlet obstruction. Although the voiding symptoms associated with the change in bladder health over time predominantly impact the quality of a man's daily experience, there are also significant medical consequences of BPH that require intervention. It is a challenge to distinguish men who are at risk for these medical consequences from the much larger population of older men with voiding symptoms (lower urinary tract symptoms, LUTS). A variety of national guidelines have been developed to establish a diagnostic paradigm for meeting this challenge, but all suffer from inadequate sensitivity for the early identification of men at risk for permanent bladder injury. It is likely that the application of a thorough pelvic ultrasound designed to identify the pertinent anatomic aspects of both the bladder and prostate will improve the sensitivity of these diagnostic paradigms, with subsequent improvement in the outcomes for men with BPH/LUTS.

The prostatic urethral lift for the treatment of lower urinary tract symptoms associated with prostate enlargement due to benign prostatic hyperplasia: the L.I.F.T. Study.

PURPOSE: We report the first multicenter randomized blinded trial of the prostatic urethral lift for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. MATERIALS AND METHODS: Men at least 50 years old with AUASI (American Urological Association Symptom Index) 13 or greater, a maximum flow rate 12 ml per second or less and a prostate 30 to 80 cc were randomized 2:1 between prostatic urethral lift and sham. In the prostatic urethral lift group small permanent implants are placed within the prostate to retract encroaching lobes and open the prostatic urethra. Sham entailed rigid cystoscopy with sounds mimicking the prostatic urethral lift. The primary end point was comparison of AUASI reduction at 3 months. The prostatic urethral lift arm subjects were followed to 1 year and assessed for lower urinary tract symptoms, peak urinary flow rate, quality of life and sexual function. RESULTS: A total of 206 men were randomized (prostatic urethral lift 140 vs sham 66). The prostatic urethral lift and sham AUASI was reduced by 11.1±7.67 and 5.9±7.66, respectively (p=0.003), thus meeting the primary end point. Prostatic urethral lift subjects experienced AUASI reduction from 22.1 baseline to 18.0, 11.0 and 11.1 at 2 weeks, 3 months and 12 months, respectively, p<0.001. Peak urinary flow rate increased 4.4 ml per second at 3 months and was sustained at 4.0 ml per second at 12 months, p<0.001. Adverse events were typically mild and transient. There was no occurrence of de novo ejaculatory or erectile dysfunction. CONCLUSIONS: The prostatic urethral lift, reliably performed with the patient under local anesthesia, provides rapid and sustained improvement in symptoms and flow, while preserving sexual function.

Prostatic Urethral Lift Versus Medical Therapy: Examining the Impact on Sexual Function in Men with Benign Prostatic Hyperplasia.

BACKGROUND: Sexual dysfunction is a common side effect of medical therapy for benign prostatic hyperplasia (BPH), whereas prostatic urethral lift (PUL) offers safe and effective relief of lower urinary tract symptoms while preserving sexual function. OBJECTIVE: To compare the long-term impact on sexual health of PUL or daily medical therapy of doxazosin or finasteride alone or in combination in BPH patients. DESIGN, SETTING, AND PARTICIPANTS: This was a comparative analysis of sexual function outcomes from PUL studies (L.I.F.T. [n=107], Crossover [n=42], and MedLift [n=39]) and the Medical Therapy of Prostatic Symptoms (MTOPS) trial. The men included were sexually active with International Prostate Symptom Score ≥13, Qmax ≤12ml/s, and prostate volume 30-80 cm3. MTOPS subjects completed the Brief Male Sexual Function Inventory, while PUL subjects completed the International Index of Erectile Function and the Male Sexual Health Questionnaire for Ejaculatory Function. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Mean percentage changes from baseline in erectile, ejaculatory, and sexual satisfaction domains were compared at 12, 24, 36, and 48 mo. RESULTS AND LIMITATIONS: PUL significantly improved erectile function through 24 mo, and ejaculatory function and sexual satisfaction across all time points. Medical therapy did not improve sexual function at any time point. Finasteride significantly decreased erectile function at 48 mo, and combined therapy significantly reduced ejaculatory function at 12 and 24 mo. Comparatively, PUL was superior to finasteride in preserving erectile function at 24 and 48 mo, and superior to doxazosin and combined therapy at 12 mo. PUL outperformed all three medical therapies at all time points in improving ejaculatory function and sexual satisfaction. Limitations include the use of distinct patient-reported questionnaires and narrowed data on comorbidities that influence male sexual function. CONCLUSIONS: Indirect comparison reveals that PUL is superior to BPH medical therapy in preserving erectile and ejaculatory function and sexual satisfaction. PATIENT SUMMARY: In our non-head-to-head study, only patients undergoing PUL for an enlarged prostate experienced improvements in sexual health. Conversely, patients on medical therapy experienced worsening of erectile and ejaculatory function.

Diagnosis and Treatment of Urethrocavernous Fistula Presenting as Urethral Bleeding.

Urethrocavernous fistula is rarely reported, though should be considered within the differential diagnosis for men who present with urethral bleeding, particularly at time of erection. Ultrasonography with concomitant intracavernosal injection can be considered to confirm the diagnosis. Here we report a case of urethrocavernous fistula in a 48 year old man without preceding traumatic event.

Percutaneous ultrasound-guided cryoablation of renal tumors using the CIVCO assist positioning system.

Cryoablation is emerging as an accepted treatment for small renal tumors. Percutaneous placement of cryoprobes using ultrasound guidance is an attractive option for patients with tumors easily seen with transabdominal ultrasonography; however, the placement of probes using hand-held devices is technically challenging. To improve the accuracy and ease of cryoprobe placement during percutaneous renal cryoablation, we describe the novel application of the CIVCO Assist positioning arm system during these complex procedures.

Durability of the Prostatic Urethral Lift: 2-Year Results of the L.I.F.T. Study.

INTRODUCTION: For a therapy to become an important part of a provider armamentarium it must be safer or better than existing therapies and be durable. The prostatic urethral lift offers rapid improvement in lower urinary tract symptoms associated with benign prostatic hyperplasia with minimal side effects. We report 2-year results of a multicenter, randomized, blinded trial of the prostatic urethral lift. METHODS: A total of 206 men 50 years old or older with an AUA-SI of 13 or greater, a peak flow rate of 12 ml per second or less and a 30 to 80 cc prostate were randomized 2:1 between the prostatic urethral lift and sham treatment. The prostatic urethral lift is performed by placing permanent transprostatic implants to lift apart the prostate lobes and reduce urethral obstruction. Sham treatment entailed rigid cystoscopy, a blinding screen and sounds that mimicked those of the prostatic urethral lift procedure. Patients were assessed for lower urinary tract symptoms, peak flow rate, quality of life and sexual function. RESULTS: The prostatic urethral lift reduced the AUA-SI 88% more than sham treatment (-11.1 vs -5.9, p = 0.003). Patients with the prostatic urethral lift experienced an AUA-SI reduction from 22.1 at baseline to 18.0 (-17%), 11.1 (-50%), 11.4 (-48%) and 12.5 (-42%) at 2 weeks, 3 months, and 1 and 2 years, respectively (p <0.0001). The peak flow rate was increased 4.2 ml per second at 3 months and 2 years (p <0.0001). By 2 years only 7.5% of patients required additional intervention for lower urinary tract symptoms. Adverse events were typically mild and transient. Encrustation did not develop on implants properly placed in the prostate. There was no occurrence of de novo sustained ejaculatory or erectile dysfunction. CONCLUSIONS: The prostatic urethral lift preserves sexual function and provides rapid improvement in symptoms, flow and quality of life that are sustained to 2 years.

Preliminary experience with cryoablation of renal lesions smaller than 4 centimeters.

Nephron-sparing surgical techniques represent an attractive treatment approach for small renal lesions that are limited only by potential operative morbidity. This study tests the hypothesis that an alternative strategy of in situ cryoablation of these lesions may further reduce the incidence of complications with similar efficacy. Beginning August 1996,17 patients were enrolled in an institutional review board-approved protocol for open renal cryoablation for lesions smaller than 4 cm in diameter. The median age was 62 years (range, 35-75 years). The median preoperative lesion size was 2.0 cm (range, 1.1-4.2 cm) determined with either computed tomography or magnetic resonance imaging. A double freeze-thaw technique to -180 degrees C was used under direct intraoperative ultrasound monitoring. The median length of follow-up was 30 months (range, 10-60 months), with 8 patients followed up for more than 20 months. The procedure was accomplished in 3 hours (range, 2.25-4.25 hours) through a 5-cm to 7-cm subcostal incision. The median blood loss was 100 mL, and the median hospital stay was 2 days (range, 2-8 days). The median intraoperative lesion was 2.4 cm, which was not statistically different from preoperative measurements. Postoperative serum creatinine levels were unchanged except for a transient increase from 5.5 mg/dL to 7.0 mg/dL in one patient. Follow-up magnetic resonance imaging scans have demonstrated infarction and a reduction of lesion size in 15 of 16 cases. The size of one patient's mass was unchanged after 3 months. Renal cryoablation via an open approach is associated with few complications and represents a viable alternative to extirpative surgical techniques. The open exposure provides an accurate assessment of the renal unit with definitive ultrasound visualization.

Long-term results of cryoablation for renal cancer and complex renal masses.

The purpose of this article is to review our experience with 5-year clinical follow-up after cryosurgical ablation of renal neoplasms. A retrospective review of a de-identified database was undertaken to retrieve information on patients with > or = 36 months' follow-up. Patient demographics, tumor characteristics, radiologic follow-up, and disease-free and overall survival data were evaluated. A total of 48 patients, with a median follow-up of 64 months (range, 36-110 months) and an overall survival rate of 89.5% were identified. Median lesion size was 2.6 cm (range, 1.1-4.6 cm). A total of 12.5% patients were diagnosed with persistent disease during the follow-up period. The cancer-specific survival rate was 100%, and the cancer-free survival rate after a single cryoablation procedure was 87.5%. This improved to 97.5% after a repeat procedure. No major complications were observed. Our data suggest that cryosurgical ablation of renal neoplasms can lead to acceptable long-term disease-free survival. Careful radiologic follow-up strategies are crucial in monitoring treatment success and identifying those who may require a secondary salvage procedure.

Treatment options after failure of radiation therapy-a review.

Radioresistant or recurrent prostate cancer represents a serious health risk for approximately 20%-30% of patients treated with primary radiation therapy for clinically localized prostate cancer. The majority of patients exhibit large volume and poorly differentiated disease at the time of diagnosis, which limits the ability of salvage therapy to eradicate the cancer. Early detection with serum PSA monitoring and prostate needle biopsy following primary radiation therapy may identify residual adenocarcinoma at an earlier stage and increase the likelihood of successful salvage therapy. Radical prostatectomy, prostate cryoablation, and brachytherapy comprise the options for salvage treatment available for radiorecurrent prostate cancer. The goal of disease eradication must be balanced against the potential for serious treatment-related side effects. As a result, many patients receive noncurative therapy with androgen ablation despite the real risk of disease progression and mortality.

Prostate cryoablation: a scientific rationale for future modifications.

This investigation was designed to identify potential directions for future modification of the percutaneous prostate cryoablation procedure. An analysis of prostate cancer location and volume in radical prostatectomy specimens was performed to evaluate the potential clinical consequences of these proposed modifications. A list of recommendations for improvements in the prostate cryoablation procedure was compiled from informal discussions held with participants in 9 training courses and conferences on prostate cryoablation over 18 months. Subsequently, a population of 112 consecutive, sagittally sectioned whole-mount radical prostatectomy samples was evaluated for prostate cancer volume, number of individual foci, and location to examine the disease-specific outcomes of these proposed modifications. The most common areas for potential alterations in the current cryoablation technique include modifications that would further simplify the procedure, continue to reduce real and perceived toxicity, and augment efficacy. Importantly, modifications designed to reduce treatment side effects could conflict with efforts designed to improve eradication of prostate cancer. Pathologic analysis revealed multifocal cancer in 79.5% of the samples, with 66% of cases exhibiting cancer within 5 mm of the urethra. The median volume of the index cancer was 1.6 cm3, whereas the median volume of the smaller ancillary lesions was 0.3 cm3. Prostate parenchymal-sparing alterations, proposed to reduce incontinence and erectile dysfunction by targeting the index cancer, would likely eradicate clinically significant cancer in 79% of men. The recent enthusiasm for prostate cryoablation as a reasonable minimally invasive treatment option for men with clinically localized cancer is likely to result in modifications of the established surgical technique. Knowledge of the anatomic location and cancer volume within the prostate gland is an important adjunct to planning such alterations. It is possible that parenchymal-sparing modifications to total gland prostate cryoablation can eradicate clinically significant cancer in most men, with a reduction in toxicity and cost.