Eric Barret

Laparoscopic Radical Prostatectomy: Technical and Early Oncological Assessment of 40 Operations

Objective: To evaluate the technical feasibility, oncological efficacy and intraoperative and postoperative morbidity of laparoscopic radical prostatectomy. Method: We describe an original technique of laparoscopic radical prostatectomy performed in 40 patients between 26th January and 12th October, 1998. Results: Radical prostatectomy was performed entirely by laparoscopy in 35 patients (87.5%) and only one conversion was performed in the last 26 patients (4%). Pelvic lymphadenectomy was performed in the light of preoperative staging data in 14 patients (35%). The median total operating time was 270 min. The only major complication was a rectal injury (patient 8), sutured laparoscopically with an uneventful postoperative course. Postoperative vesical catheterization lasted an average of 7.65 days. Seven patients were transfused (17.5%) with an average of 2.8 units of packed cells (range: 2–3). The reduction of postoperative pain is an element allowing for a rapid discharge of the patients by the 3rd postoperative day. The oncological results were as follows: 36 patients had a pT2 tumor (90%); prostate tumor was staged as N0 in 14 cases and NX in 26 cases. Surgical margins were negative in 33 patients (82.5%). Two patients had a doubtful resection margin (1 at the apex and 1 at the bladder neck) and 5 patients had positive margins. The last PSA level was undetectable (<0.1 ng/ml) in 26 (89.7%) of the 29 patients in whom PSA level was available more than 1 month after the operation. Functional results are not yet available and will be published later. Conclusions: Radical prostatectomy is an operation which can be routinely performed by laparoscopy by a team experienced with this technique. Operative and postoperative morbidity was low. Short-term oncological data appear identical to the results of conventional retropubic surgery. The improvement of operative visibility was considerable allowing a much more precise dissection. The laparoscopic approach appears to represent a technical improvement of the radical prostatectomy if the functional results of this operation improve parallel to the quality of dissection. A long-term follow-up is needed to define definitively the place of this new approach to radical prostatectomy.

The Current Status of Laparoscopic Sacrocolpopexy: A Review

CONTEXTnPelvic organ prolapse (POP) is a common problem in women that causes morbidity and a decreased quality of life. Sacrocolpopexy can treat women with vaginal vault prolapse (VVP), multicompartmental POP, and/or a history of failed prolapse procedures. Abdominal sacrocolpopexy (ASC) is the gold standard for VVP and is superior to vaginal sacrocolpopexy, with fewer recurrent prolapses and less dyspareunia. Vaginal prolapse repairs, however, are often faster and offer patients a shorter recovery time. Laparoscopic sacrocolpopexy (LSC) aims to bridge this gap and to provide the outcomes of ASC with decreased morbidity.nnnOBJECTIVEnThis review evaluates the recent literature on LSC as a therapy for POP.nnnEVIDENCE ACQUISITIONnA PubMed search of the available English literature on LSC was performed. The reference lists of selected articles were reviewed, and additional on-topic articles were included. Some 50 articles were screened, 22 articles were selected, and the reported outcomes from 11 series are presented in this review.nnnEVIDENCE SYNTHESISnLaparoscopic experience with POP has advanced tremendously, and LSC results from >1000 patients in 11 series support this. Conversion rates and operative times have decreased with increased experience. Mean operative time was 158 min (range: 96-286 min) with a 2.7% conversion rate (range: 0-11%) and a 1.6% early reoperation rate (range: 0-3.9%). With a mean follow-up of 24.6 mo (range: 11.4-66 mo), there was, on average, a 94.4% satisfaction rate, a 6.2% prolapse reoperation rate, and a 2.7% mesh erosion rate. Several centers have demonstrated that excellent outcomes with LSC are reproducible in terms of operative parameters, durable results, minimal complications, and high levels of patient satisfaction.nnnCONCLUSIONSnLSC upholds the outcomes of the gold standard ASC with minimal morbidity. Longer prospective and randomized trials are needed to confirm these results.

Laparoscopic radical prostatectomy : Assessment after 240 procedures

Radical prostatectomy can be successfully performed by transperitoneal laparoscopy by a urologic team experienced in laparoscopy and radical prostatectomy. Operative and postoperative morbidity rates are low. Postoperative pain is minimal, allowing reduction of the length of hospital stay. The oncologic results seem satisfactory based on short-term follow-up. The improvement of the quality of intraoperative vision related to magnification of the image allows a more precise procedure. This subjective improvement of the quality of dissection should reduce the usual functional sequelae of conventional radical prostatectomy, such as incontinence and impotence. This finding needs to be confirmed by a larger series of patients with longer follow-up. Laparoscopic radical prostatectomy is now performed routinely and is proposed as a first-line surgical treatment for localized prostatic cancer at the authors center.

Focal Therapy in Prostate Cancer: International Multidisciplinary Consensus on Trial Design

BACKGROUNDnFocal therapy has been introduced for the treatment of localised prostate cancer (PCa). To provide the necessary data for consistent assessment, all focal therapy trials should be performed according to uniform, systematic pre- and post-treatment evaluation with well-defined end points and strict inclusion and exclusion criteria.nnnOBJECTIVEnTo obtain consensus on trial design for focal therapy in PCa.nnnDESIGN, SETTING, AND PARTICIPANTSnA four-staged consensus project based on a modified Delphi process was conducted in which 48 experts in focal therapy of PCa participated. According to this formal consensus-building method, participants were asked to fill out an iterative sequence of questionnaires to collect data on trial design. Subsequently, a consensus meeting was held in which 13 panellists discussed acquired data, clarified the results, and defined the conclusions.nnnOUTCOME MEASUREMENTS AND STATISTICAL ANALYSISnA multidisciplinary board from oncologic centres worldwide reached consensus on patient selection, pretreatment assessment, evaluation of outcome, and follow-up.nnnRESULTS AND LIMITATIONSnInclusion criteria for candidates in focal therapy trials are patients with prostate-specific antigen <15 ng/ml, clinical stage T1c-T2a, Gleason score 3+3 or 3+4, life expectancy of >10 yr, and any prostate volume. The optimal biopsy strategy includes transrectal ultrasound-guided biopsies to be taken between 6 mo and 12 mo after treatment. The primary objective should be focal ablation of clinically significant disease with negative biopsies at 12 mo after treatment as the primary end point.nnnCONCLUSIONSnThis consensus report provides a standard for designing a feasible focal therapy trial.nnnPATIENT SUMMARYnA variety of ablative technologies have been introduced and applied in a focal manner for the treatment of prostate cancer (PCa). In this consensus report, an international panel of experts in the field of PCa determined pre- and post-treatment work-up for focal therapy research.

Focal Therapy: Patients, Interventions, and Outcomes—A Report from a Consensus Meeting

Background Focal therapy as a treatment option for localized prostate cancer (PCa) is an increasingly popular and rapidly evolving field. Objective To gather expert opinion on patient selection, interventions, and meaningful outcome measures for focal therapy in clinical practice and trial design. Design, setting, and participants Fifteen experts in focal therapy followed a modified two-stage RAND/University of California, Los Angeles (UCLA) Appropriateness Methodology process. All participants independently scored 246 statements prior to rescoring at a face-to-face meeting. The meeting occurred in June 2013 at the Royal Society of Medicine, London, supported by the Wellcome Trust and the UK Department of Health. Outcome measurements and statistical analysis Agreement, disagreement, or uncertainty were calculated as the median panel score. Consensus was derived from the interpercentile range adjusted for symmetry level. Results and limitations Of 246 statements, 154 (63%) reached consensus. Items of agreement included the following: patients with intermediate risk and patients with unifocal and multifocal PCa are eligible for focal treatment; magnetic resonance imaging–targeted or template-mapping biopsy should be used to plan treatment; planned treatment margins should be 5 mm from the known tumor; prostate volume or age should not be a primary determinant of eligibility; foci of indolent cancer can be left untreated when treating the dominant index lesion; histologic outcomes should be defined by targeted biopsy at 1 yr; residual disease in the treated area of ≤3 mm of Gleason 3 + 3 did not need further treatment; and focal retreatment rates of ≤20% should be considered clinically acceptable but subsequent whole-gland therapy deemed a failure of focal therapy. All statements are expert opinion and therefore constitute level 5 evidence and may not reflect wider clinical consensus. Conclusions The landscape of PCa treatment is rapidly evolving with new treatment technologies. This consensus meeting provides guidance to clinicians on current expert thinking in the field of focal therapy. Patient summary In this report we present expert opinion on patient selection, interventions, and meaningful outcomes for clinicians working in focal therapy for prostate cancer.

Focal therapy with high-intensity focused ultrasound for prostate cancer in the elderly: a feasibility study with 10 years follow-up

PURPOSEnTo evaluate the long-term efficacy of prostate cancer control and complication rates, in the elderly, after focal therapy with high-intensity focused ultrasound (HIFU).nnnMATERIALS AND METHODSnBetween June 1997 and March 2000, patients with localized prostate cancer were included into a focal therapy protocol. Inclusion criteria were: PSA ≤ 10 ng/mL, ≤ 3 positive biopsies with only 1 lobe involved, clinical stage ≤ T2a, Gleason score ≤ 7 (3+4), negative CT scan and bone scan. Hemi-ablation of the prostate was performed with the Ablatherm® device. Survival, complication rates and urinary continence were evaluated. Control biopsies were performed at 1 year. Treatment failure was defined as a positive biopsy or need for salvage therapy.nnnRESULTSnTwelve patients with a mean age 70 years were included. Median follow-up was 10 years. Control prostate biopsies were negative in 11/12 (91%) patients. Overall survival was 83% (10/12) and cancer specific survival was 100% at 10 years. Two patients died from other causes. Recurrence free survival was 90% (95% CI; 0.71-1) at 5 years, and 38% (95% CI; 0.04-0.73) at 10 years. Five patients had salvage therapy with repeat HIFU (n = 1) or hormonal therapy (n = 4) and all salvage patients were alive at 10 years. No patients developed lymph node or bone metastasis. No patients suffered from urinary incontinence. International Prostate Symptom Score was stable at 1 year. Complications included two urinary tract infections and one episode of acute urinary retention.nnnCONCLUSIONSnHemi-prostate ablation with HIFU can be safely performed in selected elderly patients with adequate long-term cancer control and low complication rates. Results from larger prospective studies using improved imaging techniques and extensive biopsy protocols are awaited.

Padeliporfin vascular-targeted photodynamic therapy versus active surveillance in men with low-risk prostate cancer (CLIN1001 PCM301): an open-label, phase 3, randomised controlled trial

BACKGROUNDnVascular-targeted photodynamic therapy, a novel tissue-preserving treatment for low-risk prostate cancer, has shown favourable safety and efficacy results in single-arm phase 1 and 2 studies. We compared this treatment with the standard of care, active surveillance, in men with low-risk prostate cancer in a phase 3 trial.nnnMETHODSnThis randomised controlled trial was done in 47 European university centres and community hospitals. Men with low-risk, localised prostate cancer (Gleason pattern 3) who had received no previous treatment were randomly assigned (1:1) to vascular-targeted photodynamic therapy (4 mg/kg padeliporfin intravenously over 10 min and optical fibres inserted into the prostate to cover the desired treatment zone and subsequent activation by laser light 753 nm with a fixed power of 150 mW/cm for 22 min 15 s) or active surveillance. Randomisation was done by a web-based allocation system stratified by centre with balanced blocks of two or four patients. Best practice for active surveillance at the time of study design was followed (ie, biopsy at 12-month intervals and prostate-specific antigen measurement and digital rectal examination at 3-month intervals). The co-primary endpoints were treatment failure (histological progression of cancer from low to moderate or high risk or death during 24 months follow-up) and absence of definite cancer (absence of any histology result definitely positive for cancer at month 24). Analysis was by intention to treat. Treatment was open-label, but investigators assessing primary efficacy outcomes were masked to treatment allocation. This trial is registered with ClinicalTrials.gov, number NCT01310894.nnnFINDINGSnBetween March 8, 2011, and April 30, 2013, we randomly assigned 206 patients to vascular-targeted photodynamic therapy and 207 patients to active surveillance. Median follow-up was 24 months (IQR 24-25). The proportion of participants who had disease progression at month 24 was 58 (28%) of 206 in the vascular-targeted photodynamic therapy group compared with 120 (58%) of 207 in the active surveillance group (adjusted hazard ratio 0·34, 95% CI 0·24-0·46; p<0·0001). 101 (49%) men in the vascular-targeted photodynamic therapy group had a negative prostate biopsy result at 24 months post treatment compared with 28 (14%) men in the active surveillance group (adjusted risk ratio 3·67, 95% CI 2·53-5·33; p<0·0001). Vascular-targeted photodynamic therapy was well tolerated. The most common grade 3-4 adverse events were prostatitis (three [2%] in the vascular-targeted photodynamic therapy group vs one [<1%] in the active surveillance group), acute urinary retention (three [2%] vs one [<1%]) and erectile dysfunction (two [1%] vs three [1%]). The most common serious adverse event in the vascular-targeted photodynamic therapy group was retention of urine (15 patients; severe in three); this event resolved within 2 months in all patients. The most common serious adverse event in the active surveillance group was myocardial infarction (three patients).nnnINTERPRETATIONnPadeliporfin vascular-targeted photodynamic therapy is a safe, effective treatment for low-risk, localised prostate cancer. This treatment might allow more men to consider a tissue-preserving approach and defer or avoid radical therapy.nnnFUNDINGnSteba Biotech.

Focal High-intensity Focused Ultrasound Targeted Hemiablation for Unilateral Prostate Cancer: A Prospective Evaluation of Oncologic and Functional Outcomes

BACKGROUNDnIn selected patients with unilateral, organ-confined prostate cancer (PCa), hemiablation of the affected lobe might be feasible to achieve acceptable cancer control with fewer complications.nnnOBJECTIVESnTo assess the oncologic and functional outcomes of focal high-intensity focused ultrasound (HIFU) hemiablation in unilateral organ-confined PCa.nnnDESIGN, SETTING AND PATIENTSnSingle-center prospective evaluation of HIFU hemiablation for unilateral organ-confined PCa was performed from July 2009 through December 2013.nnnINTERVENTIONnCancer localization was done with transrectal ultrasound-guided biopsy and multiparametric magnetic resonance imaging followed by HIFU hemiablation.nnnOUTCOME MEASUREMENT AND STATISTICAL ANALYSISnOncologic outcomes were analyzed with control biopsies and prostate-specific antigen (PSA) measurement. Functional outcomes were assessed with validated questionnaires for genitourinary symptoms.nnnRESULTS AND LIMITATIONSnOf 71 HIFU hemiablation patients, 67 completed the study protocol. The mean age was 70.2 yr (standard deviation: 6.8 yr), and median PSA was 6.1 ng/ml (interquartile range [IQR]: 1.6-15.5 ng/ml). Median maximum cancer-core length was 3 mm (IQR: 2-10 mm), and total cancer length was 6.5 mm (IQR: 2-24 mm). Gleason score was 6 (3+3) in 58 patients (86.6%) and 7 (3+4) in 9 patients (13.4%). Median follow-up was 12 mo (IQR: 6-50 mo), and at 12 mo, 56 of 67 patients had a negative control biopsy in the treated lobe. At 3 mo, all patients were continent, and potency was maintained in 11 of 21 preoperatively potent patients (confidence interval, 0.18-0.69). Complications included 8% Clavien-Dindo grade 2 and 2.8% grade 3 events.nnnCONCLUSIONSnFocal HIFU hemiablation appears to achieve acceptable oncologic outcomes with low morbidity and minimal functional changes. Longer follow-up will establish future considerations.nnnPATIENT SUMMARYnThis study showed that high-intensity focused ultrasound hemiablation in selected patients with unilateral organ-confined prostate cancer can be used for satisfactory cancer control with minimal effect on genitourinary functions.

Development of a standardised training curriculum for robotic surgery: a consensus statement from an international multidisciplinary group of experts

To explore the views of experts about the development and validation of a robotic surgery training curriculum, and how this should be implemented.

TOOKAD® Soluble focal therapy: pooled analysis of three phase II studies assessing the minimally invasive ablation of localized prostate cancer

AbstractPurposenTo evaluate the 6-month effects of the recommended drug and light dosage in focal vascular-targeted photodynamic therapy (VTP) using TOOKAD® Soluble in patients with localized prostate cancer (LPCa).MethodsWe performed a pooled analysis of 117 men with LPCa, PSA <10xa0ng/mL, and Gleason score ≤7 (3xa0+xa04), from 3 studies who received a 10-min intravenous infusion of a single dose of 4xa0mg/kg TOOKAD® Soluble, activated by a 753-nm light at 200xa0J/cm delivered in the prostate by transperineal fibres under transrectal ultrasound guidance. Primary endpoint was 6-month negative biopsies in the treated lobe(s). PSA was measured at month 1, 3, and 6. Magnetic resonance imaging was performed at day 7, month 3, and 6. International Prostate Symptom Score (IPSS), International Index of Erectile Function (IIEF-5) and adverse events were reported at day 7, month 1, 3, and 6.ResultsMonth 6 negative biopsy rate was 68.4xa0% in the overall evaluable population (Nxa0=xa0114) and 80.6xa0% for patients treated by hemiablation with light density index (LDI)xa0≥xa01 (Nxa0=xa067). Mean prostate necroses at week-1 were 76.5 and 86.3xa0%, respectively. In both groups, PSA levels at month 6 decreased by 2.0xa0ng/mL. Small changes from baseline for IPSS and IIEF-5 indicated a slight improvement in urinary function and a slight deterioration in sexual function.ConclusionsFocal VTP treatment with TOOKAD® Soluble at 4xa0mg/kg and 200xa0J/cm resulted in a negative 6-month biopsy rate of 68.4xa0% for the whole population and 80.6xa0% for patients treated by hemiablation with LDIxa0≥xa01. The treatment was well tolerated. Two phase III studies will reach completion in early 2015.