The role of routine follow-up visits of prostate cancer survivors in addressing supportive care and information needs: a qualitative observational study.

PURPOSE: To understand the role of routine follow-up visits in addressing prostate cancer survivors' supportive care and information needs. METHODS: We audio-recorded follow-up visits of 32 prostate cancer survivors. Follow-up visits were analyzed according to the Verona Network of Sequence Analysis. We categorized survivors' cues, concerns, and questions into five supportive care domains and divided the responses by the healthcare professionals into providing versus reducing space that is to determine whether or not the response invites the patient to talk more about the expressed cue or concern. RESULTS: Prostate cancer survivors mostly expressed cues, concerns, and questions (in the health system and information domain) about test results, potential impotence treatment, follow-up appointments, and (their) cancer treatment during follow-up visits. Survivors also expressed urinary complaints (physical and daily living domain) and worry about the recurrence of prostate cancer (psychological domain). Healthcare professionals were two times more likely to provide space on cues and concerns related to the physical and daily living domain than to psychological related issues. CONCLUSION: Follow-up visits can serve to address prostate cancer survivors' supportive care and information needs, especially on the health system, information, and physical and daily living domain. Survivors also expressed problems in the psychological domain, although healthcare professionals scarcely provided space to these issues. We would like to encourage clinicians to use these results to personalize follow-up care. Also, these data can be used to develop tailored (eHealth) interventions to address supportive care and information needs and to develop new models of survivorship care delivery.

EAU-ESMO Consensus Statements on the Management of Advanced and Variant Bladder Cancer-An International Collaborative Multistakeholder Effort†: Under the Auspices of the EAU-ESMO Guidelines Committees.

BACKGROUND: Although guidelines exist for advanced and variant bladder cancer management, evidence is limited/conflicting in some areas and the optimal approach remains controversial. OBJECTIVE: To bring together a large multidisciplinary group of experts to develop consensus statements on controversial topics in bladder cancer management. DESIGN: A steering committee compiled proposed statements regarding advanced and variant bladder cancer management which were assessed by 113 experts in a Delphi survey. Statements not reaching consensus were reviewed; those prioritised were revised by a panel of 45 experts prior to voting during a consensus conference. SETTING: Online Delphi survey and consensus conference. PARTICIPANTS: The European Association of Urology (EAU), the European Society for Medical Oncology (ESMO), experts in bladder cancer management. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Statements were ranked by experts according to their level of agreement: 1-3 (disagree), 4-6 (equivocal), and 7-9 (agree). A priori (level 1) consensus was defined as ≥70% agreement and ≤15% disagreement, or vice versa. In the Delphi survey, a second analysis was restricted to stakeholder group(s) considered to have adequate expertise relating to each statement (to achieve level 2 consensus). RESULTS AND LIMITATIONS: Overall, 116 statements were included in the Delphi survey. Of these statements, 33 (28%) achieved level 1 consensus and 49 (42%) achieved level 1 or 2 consensus. At the consensus conference, 22 of 27 (81%) statements achieved consensus. These consensus statements provide further guidance across a broad range of topics, including the management of variant histologies, the role/limitations of prognostic biomarkers in clinical decision making, bladder preservation strategies, modern radiotherapy techniques, the management of oligometastatic disease, and the evolving role of checkpoint inhibitor therapy in metastatic disease. CONCLUSIONS: These consensus statements provide further guidance on controversial topics in advanced and variant bladder cancer management until a time when further evidence is available to guide our approach. PATIENT SUMMARY: This report summarises findings from an international, multistakeholder project organised by the EAU and ESMO. In this project, a steering committee identified areas of bladder cancer management where there is currently no good-quality evidence to guide treatment decisions. From this, they developed a series of proposed statements, 71 of which achieved consensus by a large group of experts in the field of bladder cancer. It is anticipated that these statements will provide further guidance to health care professionals and could help improve patient outcomes until a time when good-quality evidence is available.

Peroperative transrectal ultrasonography-guided bladder neck dissection eases the learning of robot-assisted laparoscopic prostatectomy.

OBJECTIVE: To study the role of peroperative transrectal ultrasonography (peTRUS) for the dissection of the bladder neck during robot-assisted laparoscopic prostatectomy (RALP). PATIENTS AND METHODS: Integrated peTRUS in the da Vinci S system (Intuitive Surgical, Sunnyvale, CA, USA) was used for bladder neck identification and dissection in the initial 80 patients with clinically localized prostate cancer operated by two urologists. The clinical and pathological results were compared with the initial 80 patients who had RALP with no peTRUS. The location of positive margins was recorded. RESULTS: The operative duration, blood loss, hospital stay, catheter dependency, clinical and pathological T-stage and Gleason sum score were no different between the groups. The prostate-specific antigen level at time of diagnosis was slightly higher for patients in the peTRUS group. Basal surgical margins (bladder neck and basal areas of both prostate lobes) were positive for tumour in 9.1% and 2.3% of patients treated without and with peTRUS, respectively (P = 0.001). Although the use of peTRUS improved the basal margin rate in the initial 30 patients in each group, it did not in the last 30 in each group, when the urologist's experience apparently improved. In a multivariate analysis the use of peTRUS and pathological T-stage were the best predictors of basal margin status. Pad use at 6 months after surgery was similar for both groups. CONCLUSION: peTRUS during RALP decreased the positive surgical margin rate at the base of the prostate during the initial experience of RALP.

Stapling for prostate pedicle management during robot-assisted radical prostatectomy.

BACKGROUND: Prostate pedicle management is a crucial step during robot-assisted radical prostatectomy (RARP). Wide excision of prostate pedicle may be required to avoid positive surgical margins (PSMs) whereas preservation of neurovascular bundles requires resection close on the prostate. We studied Endo GIA™ stapling of prostate pedicle during RARP. METHODS: Retrospectively the outcome of 55 men who underwent RARP with Endo GIA™ stapling (45-mm Echelon Ethicon; group A) of the pedicle were compared with 100 men where another method for prostate pedicle management (mono- and bipolar electrocautery, Hem-o-Lock clips or titanium 10-mm clips; group B) was used. Both groups were matched for age, prostate size, clinical T-stage, Gleason Score and fascia preservation (FP) score (as a measure of nerve sparing). Surgical, oncological, functional outcome factors and costs were compared. RESULTS: The overall PSM rate was 33% in group A and 42% in group B (P=0.251). None of the cases had PSMs at the location of staples. PSMs with Endo GIA™ stapler at the periphery of the prostate were less frequent than in control group (4.1% vs. 11.5%; P=0.021). Median pedicle dissection time (7.8 [3.1-15.1] min vs. 10.5 [5.8-28.3] min; P=0.0001) and median operative time for RARP combined with lymphadenectomy (114 [70-129] min vs. 120 [67-200] min; P=0.043) tended to be shorter compared to group B. Erectile function and continence recovery at 12 months were comparable for both groups. Material costs for stapling (€730) were higher compared to variable costs in control group. CONCLUSIONS: Pedicle stapling during RARP reduced peripheral PSMs. It did not compromise functional results, provided a modest operation time gain for pedicle dissection, but is more expensive.

Quality of life in patients with low-risk prostate cancer. A comparative retrospective study: brachytherapy versus robot-assisted laparoscopic prostatectomy versus active surveillance.

PURPOSE: To investigate the quality of life (QoL) after different treatment modalities for low-risk prostate cancer, including brachytherapy, robot-assisted laparoscopic prostatectomy (RALP), and active surveillance (AS) with validated questionnaires. MATERIALS AND METHODS: From a prospective database, we selected a total of 144 men with low-grade localized prostate cancer including 65 (45.1%) patients with RALP, 29 (20.2%) with brachytherapy, and 50 (34.7%) whose cancer was managed with AS. QoL was routinely evaluated with validated questionnaires: The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30), EORTC-QLQ-Prostate Module (PR)25, International Index of Erectile Function (IIEF)-15, International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) with a minimum follow-up of 1 year. RESULTS: In comparison with baseline scores, the brachytherapy group showed a significant decrease of QoL domain scores of voiding complaints (P=0.010), use of incontinence aids (P=0.011), sexual functioning domain (P=0.011), and erectile function (P≤0.001). In the RALP group, sexual function (P≤0.001), incontinence (P≤0.001), and erectile function were significantly affected. A decrease in sexual function was observed in 71% of men after RALP and 59% after brachytherapy. In 30% of men under AS, a decrease of erectile function score during follow-up was reported. Overall, no significant decrease in general QoL was observed neither for men under AS nor for men treated by brachytherapy or RALP. Clinical factors such as age, prostate size, prostate-specific antigen level, and nerve preservation during RALP were nonpredictive of overall QoL after treatment for the individual patient (P=0.676). CONCLUSION: Patients with low-risk prostate cancer who are treated with brachytherapy or RALP report deterioration of QoL of specific domains such as voiding, continence, and sexual functioning in comparison with AS patients. A decrease of erectile function was also observed during AS. Overall QoL was similar for all three treatments options.

Impact on quality of life of radical prostatectomy after initial active surveillance: more to lose?

OBJECTIVE: The aim of this study was to determine whether deferred radical therapy for low-risk prostate cancer has an additionally unfavourable effect on quality of life (QoL). Substantial numbers of patients on active surveillance (AS) are eventually treated. MATERIAL AND METHODS: Prostate cancer patients treated with robot-assisted radical prostatectomy (RARP) in the NCI-AvL (Amsterdam, The Netherlands) received systematic QoL questionnaires preoperatively and postoperatively. Questionnaires included the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core Module and Prostate Module (EORTC-QLQ-C30 and EORTC-QLQ-PR25), International Index of Erectile Function-15 (IIEF-15) and International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF). Patients with low-risk prostate cancer who received RARP after an initial period of AS (AS-RARP group) were compared with similar patients who primarily elected surgery (direct-RARP group). RESULTS: The AS-RARP group included 29 patients who received RARP after a median period of 15.4 months of AS (range 3.0-18.8 months). Main reasons for deferred radical therapy were repeat biopsy risk reclassification (45%) and prostate-specific antigen progression (38%). The direct-RARP group included 363 patients treated after 3.3 months (range 0.1-45.5 months). RARP generally resulted in clinically relevant unfavourable changes on different QoL domains in both groups. Preoperatively the AS-RARP group showed more favourable scores on multiple QoL domains (physical functioning, p = 0.004; role functioning, p = 0.001; global health, p = 0.043; sexual activity, p = 0.001; sexual functioning, p = 0.029; IIEF-15, p = 0.042). Postoperatively, most of these more favourable scores in the AS-RARP group had changed to scores similar to the direct-RARP group, except for IIEF-15 (p = 0.027) and urinary symptoms (p = 0.001). When using a 12 month treatment delay threshold, a similar but less distinct effect was seen. CONCLUSIONS: Patients with low-risk prostate cancer who choose AS have more favourable preoperative QoL scores than patients who primarily elect radical prostatectomy, but these groups show similar postoperative QoL scores.

Salvage radiotherapy after robot-assisted laparoscopic radical prostatectomy.

OBJECTIVE: To assess the incidence and efficacy of salvage radiotherapy (SRT) after robot-assisted radical prostatectomy (RARP). RARP has been linked to an increased use of adjuvant treatments. If RARP would result in an increased local recurrence rate, response rates to SRT could be expected to be better after RARP than after more conventional methods of prostatectomy. The incidence and efficacy of SRT in a RARP population were compared with nomogram prediction. METHODS: Patient data were prospectively registered. Biochemical recurrence (BCR) was defined as a prostate-specific antigen (PSA) ≥0.1 ng/mL. SRT was offered to men with BCR after RARP. The Stephenson nomogram predictions were compared with outcome after SRT. RESULTS: Of 1087 men, 157 (14.4%) received SRT for BCR or persistent PSA levels during a median follow-up of 1078 days after RARP. Median PSA level before SRT was 0.2 ng/mL. Three-year BCR-free rate was 64% for men after SRT. pN (pNx, pN0, pN1) and PSA level before SRT were independent predictors of the BCR interval after SRT. Men with more extensive fascia preservation were more likely to respond favorably to SRT. The Stephenson nomogram prediction showed a concordance rate of 0.66 in this RARP population. Limitations of the study are the retrospective design and limited follow-up duration. CONCLUSION: In our RARP series, the use and efficacy of SRT were comparable with open prostatectomy series. The Stephenson nomogram reliably predicted outcome in patients with RARP with SRT, suggesting that similar characteristics predict response to SRT after RARP compared with open prostatectomy.

Interview-based versus questionnaire-based quality of life outcomes before and after prostatectomy.

INTRODUCTION: Functional outcome and quality of life (QOL) domains are important outcomes after curative therapy for prostate cancer. Although useful for scientific purposes, QOL questionnaires may be too extensive for daily routine, and single questions or interview-assessed outcomes may be more practical alternatives. The QOL outcomes of these measures were compared. MATERIALS AND METHODS: The QOL of patients undergoing Robot-Assisted Radical Prostatectomy (RARP) in our hospital was monitored before and after treatment using both brief standardized interview questions, as well as more extensive validated questionnaires. The interview questions address erectile function and urinary continence with only one question on each subject (both four response items). Questionnaires included a total of 74 questions (EORTC-QLQ-C30, EORTC-QLQ-PR25, international index of erectile function-15, and international consultation on incontinence questionnaire-short form). RESULTS: In 925 RARP patients, pre- and postoperative interview and questionnaire QOL data were available with a median follow up of 20 months. Improvement in both erectile function and continence scores occurred up till 2 years after the RARP for both interview- and questionnaire-based evaluations. On an individual patient basis, interview scores poorly correlated with questionnaire-based domains for continence and erectile function. Single questions from the questionnaire showed better correlation with domain scores. Functional recovery of continence after 1 year was worse when assessed by questionnaire than by interview evaluation. A decrease in physical (8%) and overall QOL (12%) after prostatectomy as assessed by the EORTC-QLQ-C30 questionnaire was better predicted by questionnaire-based than interview-based scores. Continence scores had a greater impact on physical and overall QOL scores than on erectile function scores. CONCLUSION: Interview/assessed continence and erectile function outcome after RARP showed limited association with questionnaire-based evaluation and may overestimate functional recovery. Continence scores for both interviews and questionnaires were stronger correlated with physical and overall QOL than erectile function scores.

Extended nodal dissection reduces sexual function recovery after robot-assisted laparoscopic prostatectomy.

BACKGROUND AND PURPOSE: Considering the anatomic proximity of the internal iliac lymph nodes and the pelvic plexus, it may be expected that more extensive pelvic nodal dissection is associated with an increased risk of damage to the small pelvis neural and vascular structures. We evaluate whether nodal dissection is associated with functional outcome after robot-assisted radical prostatectomy (RARP). PATIENTS AND METHODS: In a series of 798 RARP procedures, 325 (40.7%) patients underwent a lymph node dissection. Continence, sexual function, and lower urinary tract symptoms (LUTS) were assessed using the International Consultation of Incontinence Questionnaire short form (ICIQ)-SF), International Index of Erectile Function-15, and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ)-PR25 questionnaires before and at 6 months intervals after RARP. RESULTS: Preoperative ICIQ-SF, IIEF-15, and PR25-LUTS scores were similar for men with and without nodal dissection. Normal postoperative erectile function (IIEF-EF >24) at 6 months was reported by 1.7%, 9.1%, and 50.4% of men with no, unilateral, and bilateral nerve preservation and normal preoperative erectile function. All domains of the IIEF-15 score showed a negative correlation with the number of removed lymph nodes. In 70 of 325 (21%) cases with nodal dissection, more than 10 nodes were removed. Men with more than 10 nodes removed had lower IIEF-15 domain scores compared with men with 1 to 10 removed lymph nodes. The postoperative ICIQ-SF and PR25-LUTS scores were not associated with extent of nodal dissection. Nodal metastases were found in 5.9% and 15.7% of men with ≤ 10 nodes and >10 nodes removed (P=0.005). In a multivariate analysis, extent of fascia preservation (FP-score), preoperative IIEF-EF, and number of removed nodes were the strongest independent predictors of postoperative erectile function recovery. CONCLUSION: More extensive nodal dissection was associated with impaired postoperative sexual function recovery but not continence and voiding function after RARP, independent of preoperative function and nerve preservation.

Robot-assisted laparoscopic prostatectomy: nodal dissection results during the first 440 cases by two surgeons.

BACKGROUND: Although many studies address the learning curve for robot-assisted laparoscopic prostatectomy (RALP), little is known concerning the results for pelvic lymph node dissection (LND) during RALP. PATIENTS AND METHODS: Between 2006 and 2011, two surgeons performed 904 RALP procedures. LND was performed in 440 (48.6%) cases based on the European Association of Urology guidelines. Both surgeons had extensive experience with open LND for both prostate and bladder cancer. Clinical data were prospectively recorded into an online database. Complications were reported using the Clavien-Dindo system and documented prospectively. RESULTS: For both surgeons, the operative time for LND decreased over time during the first 150 LND procedures. After that, a mean plateau of operative time of 49 minutes for LND was reached. Nodal yield increased from a mean of 10 nodes for the first 50 cases to 14 for cases 351 to 400. The percentage of positive nodes increased significantly in these intervals from 4% to 23.1% (P<0.001, Mann Whitney U test). Overall complications by grade were not significantly different between RALP with or without LND. In 440 LND cases, 5 (1.5%) grade IIIb complications occurred. All were infection related with bowel perforation in one. Symptomatic lymphoceles necessitating drainage were present in five (1.5%) men. Thromboembolic events (0% vs 1.5%) and anastomosis dehiscence (0.2% vs 1.1%) were more common in men with LND. During the learning curve, the incidence of Clavien grade I and II but not grade III and IV complications decreased. CONCLUSION: An improvement pattern for LND during RALP is observed for operative time, nodal yield node positivity rate, and complication rate during the first 400 cases of LND.

Catheter-assisted 18F-FDG-PET/CT imaging of primary bladder cancer: a prospective study.

OBJECTIVE: The purpose of this study was to prospectively investigate the value of a standardized 18F-fluorodeoxyglucose (18F-FDG)-PET/computed tomography (CT) protocol for imaging of primary bladder cancer, using standardized bladder flushing and filling. METHODS: We included 19 patients with cT1-4 bladder cancer. A Foley catheter was inserted before 18F-FDG injection. PET/CT imaging was performed according to four bladder protocols: (1) bladder empty; (2) bladder empty after flushing; (3) bladder filled with 50 ml saline; and (4) bladder filled with 100 ml saline. Tumour visibility was assessed and compared with histopathology or CT and cystoscopy. RESULTS: The procedure was successfully completed in 16 out of 19 patients. The reference standard revealed a bladder tumour in 16 out of 19 patients. Sensitivity of protocols 1 and 2 was 0.38 [95% confidence interval (CI), 0.16-0.64] compared with 0.63 (95% CI, 0.36-0.84) for protocols 3 and 4. CONCLUSION: Flushing and subsequent retrograde filling of the bladder results in the highest rate of tumour visualization and quantification. Flushing alone is inferior.

Impact of posterior musculofascial reconstruction on early continence after robot-assisted laparoscopic radical prostatectomy: results of a prospective parallel group trial.

BACKGROUND: A significant proportion of patients develop urinary incontinence early after radical prostatectomy. Posterior reconstruction of supporting tissues has been found to reduce incontinence in open and conventional laparoscopic prostatectomy series. OBJECTIVE: To investigate whether our version of a posterior musculofascial reconstruction will reduce early incontinence and have a beneficial effect on patients' quality of life (QoL). DESIGN, SETTING, AND PARTICIPANTS: One hundred seven consecutive patients undergoing primary robot-assisted radical laparoscopic prostatectomy (RALP) performed by a single surgeon at one tertiary referral oncology institution were alternately assigned (not randomised) to intervention (n=53) or control groups (n=54). SURGICAL PROCEDURE: RALP with median fibrous raphe reconstruction (MFRR) followed by formation of the urethrovesical anastomosis (intervention group) versus standard anastomosis without posterior reconstruction (control group). MEASUREMENTS: Measurements included incontinence at baseline and 3-mo intervals; QoL as measured by a simple questionnaire, the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life-Core 30 (QLQ-C30), and Prostate Cancer Module (PR25) questionnaires preoperatively and at 6 mo postprocedure; tumour characteristics; operative time; fascial preservation score; duration of catheterisation; and anastomotic leakage on cystogram. RESULTS AND LIMITATIONS: For intervention and control groups respectively, mean catheter duration was 11.74 d and 12.74 d (p=0.451); leakage on cystogram was present in six and eight cases (p=0.28); and incontinence (any involuntary urine loss) at 3 mo was 75% and 69% (p=0.391) and at 6 mo was 51% and 43% (p=0.686). Urinary retention occurred only in one case (control group). The percentage of cases returning to baseline in all QoL domains (except insomnia) was similar at 6 mo between the two groups. Short follow-up, lack of blinding, and probable small differences in our method of MFRR performed compared with other studies were identified as significant limitations. CONCLUSIONS: No significant difference in any of the analysed outcome measures was observed. Posterior reconstruction of the musculofascial complex does not appear to improve early urinary incontinence after RALP.

Preservation of lateral prostatic fascia is associated with urine continence after robotic-assisted prostatectomy.

BACKGROUND: Among several clinical factors, nerve or prostatic fascia preservation is associated with an improved continence outcome in several studies. OBJECTIVE: We study the clinical aspects associated with urine continence after prostatectomy, paying special attention to the extent and location of fascia preservation. DESIGN, SETTING, AND PARTICIPANTS: European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life-Core 30 (QLQ-C30) and Prostate Cancer Module (PR25) questionnaires were used to evaluate quality-of-life (QoL) parameters prior to and at 6 and 12 mo after surgery for 151 men treated with robot-assisted laparoscopic prostatectomy (RALP) for localised prostate cancer. Fascia preservation was scored at 12 locations around the circumference of the prostate. Any involuntary urine loss showed a strong correlation with several domains of the EORTC QLQ-C30 and was therefore chosen as the definition of urine incontinence. INTERVENTION: Robot-assisted laparoscopic prostatectomy (RALP). MEASUREMENTS: Any urine incontinence. RESULTS AND LIMITATIONS: Of the preoperative and intraoperative characteristics, a low fascia preservation (FP) score and a higher score for preoperative voiding complaints (EORTC QLQ-P25 domain 1) were associated with an increased risk of urine incontinence and pad use at 6 and 12 mo postoperatively. In the multivariate binary logistic regression analysis, the extent of fascia preservation at the lateral aspects of the prostate as assessed by the FP score was the best predictor of urine continence at 6 and 12 mo postoperatively. The odds ratio for urine incontinence in men with preservation of the lateral prostatic fascia was 0.378 (95% CI, 0.121-0.624) and 0.289 (95% CI, 0.201-0.524) for preservation at the right and left aspects, respectively. This is a retrospective analysis not containing pad-test data. CONCLUSIONS: Fascia preservation at the lateral aspect of the prostate was the best predictor of urine continence after RALP. These data suggest that preservation of fascial support lateral rather than dorsolateral to the urethra and prostate may protect neurovascular structures important to improving postprostatectomy urine continence.