Financial Toxicity After Robot-Assisted Radical Prostatectomy and Its Relation with Oncologic, Functional Outcomes.

PURPOSE: The aim of the study was to evaluate frequency of financial toxicity among patients who underwent robot-assisted radical prostatectomy for prostate cancer. MATERIALS AND METHODS: Data of 1,479 robot-assisted radical prostatectomy patients between 2006-2021 reporting no financial toxicity in preoperative assessments were included retrospectively. Financial toxicity was measured with financial impact of European Organisation for Research and Treatment of Cancer-quality of life questionnaire-C30. Financial impact scores were collected preoperatively, 6, 12, 18, and 24 months after robot-assisted radical prostatectomy. RESULTS: The frequency of financial toxicity was 8.3% (122/1379; 95% CI 7.0-9.8) at any point in time throughout 2 years of follow-up. Patients reporting financial toxicity (63 [58-68]) were significantly younger than patients who had no financial toxicity (65 [61-69]; P = .001). There was no statistically significant difference between financial toxicity+ and financial toxicity- groups in terms of salvage radiotherapy (P = .8) and positive surgical margin (P = .2) rates. In functional assessments, clinically significant International Prostate Symptom Score and International Consultation on Incontinence Questionnaire-Short Form score increase of financial toxicity+ patients (34% and 62%) were more frequent than financial toxicity- patients (23% and 47%; P = .004 and P = .002, respectively). In multivariable analysis, age at robot-assisted radical prostatectomy, International Prostate Symptom Score, International Consultation on Incontinence Questionnaire-Short Form, and quality of life scores were associated with financial toxicity (P < .001, OR 0.95 [95% CI 0.92-0.98]; P = .015, OR 2.4 [95% CI 1.2-4.7]; P = .032, OR 1.5 [95% CI 1.2-2.5]; P = .01, OR 0.09 [95% CI 0.01-0.57], respectively). Patients who underwent robot-assisted radical prostatectomy before retirement (≤65 years) had a 1.6-fold increased financial toxicity risk (P = .003, 95% CI 1.1-2.3). CONCLUSIONS: Financial toxicity after robot-assisted radical prostatectomy is low in mid-term follow-up. Patients who report urological symptoms after robot-assisted radical prostatectomy should also be evaluated for financial toxicity. Required measures against financial toxicity should be taken especially in the follow-up of younger cancer survivors.

Cost-utility analysis on robot-assisted and laparoscopic prostatectomy based on long-term functional outcomes.

Robot-Assisted Radical Prostatectomy (RARP) is one of the standard treatment options for prostate cancer. However, controversy still exists on its added value. Based on a recent large-sample retrospective cluster study from the Netherlands showing significantly improved long-term urinary functioning after RARP compared to Laparoscopic RP (LRP), we evaluated the cost-effectiveness of RARP compared to LRP. A decision tree was constructed to measure the costs and effects from a Dutch societal perspective over a ~ 7 year time-horizon. The input was based on the aforementioned study, including patient-reported consumption of addition care and consumed care for ergonomic issues reported by surgeons. Intervention costs were calculated using a bottom-up costing analysis in 5 hospitals. Finally, a probabilistic-, one-way sensitivity- and scenario analyses were performed to show possible decision uncertainty. The intervention costs were €9964 for RARP and €7253 for LRP. Total trajectory costs were €12,078 for RARP and €10,049 for LRP. RARP showed higher QALYs compared to LRP (6.17 vs 6.11). The incremental cost-utility ratio (ICUR) was €34,206 per QALY gained, in favour of RARP. As a best-case scenario, when RARP is being centralized (> 150 cases/year), total trajectory costs decreased to €10,377 having a higher utilization, and a shorter procedure time and length of stay resulting in an ICUR of €3495 per QALY gained. RARP showed to be cost-effective compared to LRP based on data from a population-based, large scale study with 7 years of follow-up. This is a clear incentive to fully reimburse RARP, especially when hospitals provide RARP centralized.

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.

Management of patients who opt for radical prostatectomy during the coronavirus disease 2019 (COVID-19) pandemic: an international accelerated consensus statement.

OBJECTIVE: Coronavirus disease-19 (COVID-19) pandemic caused delays in definitive treatment of patients with prostate cancer. Beyond the immediate delay a backlog for future patients is expected. The objective of this work is to develop guidance on criteria for prioritisation of surgery and reconfiguring management pathways for patients with non-metastatic prostate cancer who opt for surgical treatment. A second aim was to identify the infection prevention and control (IPC) measures to achieve a low likelihood of coronavirus disease 2019 (COVID-19) hazard if radical prostatectomy (RP) was to be carried out during the outbreak and whilst the disease is endemic. METHODS: We conducted an accelerated consensus process and systematic review of the evidence on COVID-19 and reviewed international guidance on prostate cancer. These were presented to an international prostate cancer expert panel (n = 34) through an online meeting. The consensus process underwent three rounds of survey in total. Additions to the second- and third-round surveys were formulated based on the answers and comments from the previous rounds. The Consensus opinion was defined as ≥80% agreement and this was used to reconfigure the prostate cancer pathways. RESULTS: Evidence on the delayed management of patients with prostate cancer is scarce. There was 100% agreement that prostate cancer pathways should be reconfigured and measures developed to prevent nosocomial COVID-19 for patients treated surgically. Consensus was reached on prioritisation criteria of patients for surgery and management pathways for those who have delayed treatment. IPC measures to achieve a low likelihood of nosocomial COVID-19 were coined as 'COVID-19 cold' sites. CONCLUSION: Reconfiguring management pathways for patients with prostate cancer is recommended if significant delay (>3-6 months) in surgical management is unavoidable. The mapped pathways provide guidance for such patients. The IPC processes proposed provide a framework for providing RP within an environment with low COVID-19 risk during the outbreak or when the disease remains endemic. The broader concepts could be adapted to other indications beyond prostate cancer surgery.

State-of-the-art Intraoperative Imaging Technologies for Prostate Margin Assessment: A Systematic Review.

CONTEXT: The main challenge in radical prostatectomy is complete excision of malignant tissue, while preserving continence and erectile function. Positive surgical margins (PSMs) occur in up to 38% of cases, are associated with tumour recurrences, and may result in debilitating additional therapies. Despite surgical developments for prostate cancer (PCa), no technology is yet implemented to assess surgical margins of the entire prostatic surface intraoperatively. OBJECTIVE: The aim of this systematic review is to provide an overview of novel imaging methods developed for intraoperative margin assessment in PCa surgery, which are compared with standard postoperative histopathology. EVIDENCE ACQUISITION: A literature search of the last 10 yr was conducted in the Scopus, PubMed, and Embase (Ovid) databases. Eligible articles had to report the PSM rate according to their intraoperative margin assessment technology in comparison with standard histopathology. EVIDENCE SYNTHESIS: The search resulted in 616 original articles, of which 11 were included for full-text review. The main technical developments in PCa margin assessment included optical coherence tomography, photodynamic diagnosis with 5-aminolevulinic acid, spectroscopy, and enhanced microscopy. These techniques are described and their main advantages, limitations, and applications in the clinical setting are discussed. CONCLUSIONS: Several imaging methods are suggested in literature for the detection of positive margins during PCa surgery. Despite promising qualifications of the mentioned technologies, many struggle to find implementation in the clinic. Surgical conditions hampering the signal, long imaging times, and comparison with histopathology are mutual challenges. The next step towards reduction of PSMs in PCa surgery includes evaluation of these technologies in large clinical trials. PATIENT SUMMARY: In this review, new technologies are reported that can assist the surgeon by detecting insufficient removal of all tumorous tissue during surgery, instead of the standard postoperative histopathological assessment. Currently, it is not clear whether these technologies improve the patient outcome directly; however, the review shows potential future implementations.

Design of the PROstate cancer follow-up care in Secondary and Primary hEalth Care study (PROSPEC): a randomized controlled trial to evaluate the effectiveness of primary care-based follow-up of localized prostate cancer survivors.

BACKGROUND: In its 2006 report, From cancer patient to cancer survivor: lost in transition, the U.S. Institute of Medicine raised the need for a more coordinated and comprehensive care model for cancer survivors. Given the ever increasing number of cancer survivors, in general, and prostate cancer survivors, in particular, there is a need for a more sustainable model of follow-up care. Currently, patients who have completed primary treatment for localized prostate cancer are often included in a specialist-based follow-up care program. General practitioners already play a key role in providing continuous and comprehensive health care. Studies in breast and colorectal cancer suggest that general practitioners could also consider to provide survivorship care in prostate cancer. However, empirical data are needed to determine whether follow-up care of localized prostate cancer survivors by the general practitioner is a feasible alternative. METHODS: This multicenter, randomized, non-inferiority study will compare specialist-based (usual care) versus general practitioner-based (intervention) follow-up care of prostate cancer survivors who have completed primary treatment (prostatectomy or radiotherapy) for localized prostate cancer. Patients are being recruited from hospitals in the Netherlands, and randomly (1:1) allocated to specialist-based (N = 195) or general practitioner-based (N = 195) follow-up care. This trial will evaluate the effectiveness of primary care-based follow-up, in comparison to usual care, in terms of adherence to the prostate cancer surveillance guideline for the timing and frequency of prostate-specific antigen assessments, the time from a biochemical recurrence to retreatment decision-making, the management of treatment-related side effects, health-related quality of life, prostate cancer-related anxiety, continuity of care, and cost-effectiveness. The outcome measures will be assessed at randomization (≤6 months after treatment), and 12, 18, and 24 months after treatment. DISCUSSION: This multicenter, prospective, randomized study will provide empirical evidence regarding the (cost-) effectiveness of specialist-based follow-up care compared to general practitioner-based follow-up care for localized prostate cancer survivors. TRIAL REGISTRATION: Netherlands Trial Registry, Trial NL7068 (NTR7266). Prospectively registered on 11 June 2018.

Comprehensive Assessment of Indocyanine Green Usage: One Tracer, Multiple Urological Applications.

The intraoperative use of fluorescent tracers and matching cameras can empower urologists' ability to recognize critical anatomical and functional features. Indocyanine green is the most extensively used near-infrared fluorescent tracer. It has been widely applied due to its ability to illuminate vascular and lymphatic anatomies. A plurality of fluorescence cameras are available allowing the connection of this technology with many surgical approaches, including robotic surgery. Although large comparative validation studies are lacking, numerous studies support the role of fluorescence guidance in urology.

Quantitative assessment of fascia preservation improves the prediction of membranous urethral length and inner levator distance on continence outcome after robot-assisted radical prostatectomy.

AIMS: To determine whether preoperative prostate/pelvic anatomical structures and intraoperative fascia preservation (FP) predict continence recovery after robot-assisted radical prostatectomy (RARP). METHODS: Between January 2012 and March 2016, 439 prostate cancer (PCa) patients with normal preoperative continence were retrospectively included. FP score was defined as the extent of FP from base to apex of the prostate, quantitatively assessed by the surgeon. Anatomical prostate structures were measured on endorectal preoperative Magnetic Resonance Imaging. The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) was used to assess urinary incontinence (UI). Cox analysis was used to determine predictive factors for early continence recovery. Finally a binary logistic regression analysis was performed to develop a risk calculator. RESULTS: At a median follow up of 12.1 months 50.8% of men reported UI. In the Cox multivariate analysis longer membranous urethral length (MUL; P < 0.0001; OR 1.309; CI 1.211, 1.415) and shorter inner levator distance (ILD; P < 0.0001; OR 0.904; CI 0.85, 0.961) were predictors of earlier continence recovery. In the multivariate binary logistic regression analysis longer MUL (P < 0.0001; OR 1.565, CI 1.362, 1.798), shorter ILD (P < 0.0001; OR 0.819, CI 0.742, 0.904) and higher FP score (P = 0.024; OR 1.089, CI 1.011, 1.172) were independent predictors of continence outcome. The risk calculator predicted continence recovery between 1.3% and 99%. CONCLUSIONS: Preoperative longer MUL and shorter ILD, but also intraoperative FP independently improve continence recovery after RARP. The risk calculator could be used to identify patients at high risk of UI.

Structured and Modular Training Pathway for Robot-assisted Radical Prostatectomy (RARP): Validation of the RARP Assessment Score and Learning Curve Assessment.

BACKGROUND: Use of robot-assisted radical prostatectomy (RARP) for prostate cancer is increasing. Structured surgical training and objective assessment are critical for outcomes. OBJECTIVE: To develop and validate a modular training and assessment pathway via Healthcare Failure Mode and Effect Analysis (HFMEA) for trainees undertaking RARP and evaluate learning curves (LCs) for procedural steps. DESIGN, SETTING, AND PARTICIPANTS: This multi-institutional (Europe, Australia, and United States) observational prospective study used HFMEA to identify the high-risk steps of RARP. A specialist focus group enabled validation. Fifteen trainees who underwent European Association of Urology robotic surgery curriculum training performed RARP and were assessed by mentors using the tool developed. Results produced LCs for each step. A plateau above score 4 indicated competence. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: We used a modular training and assessment tool (RARP Assessment Score) to evaluate technical skills. LCs were constructed. Multivariable Kruskal-Wallis, Mann-Whitney U, and κ coefficient analyses were used. RESULTS AND LIMITATIONS: Five surgeons were observed for 42 console hours to map steps of RARP. HFMEA identified 84 failure modes and 46 potential causes with a hazard score ≥8. Content validation created the RARP Assessment Score: 17 stages and 41 steps. The RARP Assessment Score was acceptable (56.67%), feasible (96.67%), and had educational impact (100%). Fifteen robotic surgery trainees were assessed for 8 mo. In 426 RARP cases (range: 4-79), all procedural steps were attempted by trainees. Trainees were assessed with the RARP Assessment Score by their expert mentors, and LCs for individual steps were plotted. LCs demonstrated plateaus for anterior bladder neck transection (16 cases), posterior bladder neck transection (18 cases), posterior dissection (9 cases), dissection of prostatic pedicle and seminal vesicles (15 cases), and anastomosis (17 cases). Other steps did not plateau during data collection. CONCLUSIONS: The RARP Assessment Score based on HFMEA methodology identified critical steps for focused RARP training and assessed surgeons. LCs demonstrate the experience necessary to reach a level of competence in technical skills to protect patients. PATIENT SUMMARY: We developed a safety and assessment tool to gauge the technical skills of surgeons performing robot-assisted radical prostatectomy. Improvement was monitored, and measures of progress can be used in future to guide mentors when training surgeons to operate safely.

Downsides of robot-assisted laparoscopic radical prostatectomy: limitations and complications.

CONTEXT: Robot-assisted laparoscopic radical prostatectomy (RALP) using the da Vinci Surgical System (Intuitive Surgical, Sunnyvale, CA, USA) is now in widespread use for the management of localised prostate cancer (PCa). Many reports of the safety and efficacy of this procedure have been published. However, there are few specific reports of the limitations and complications of RALP. OBJECTIVE: The primary purpose of this review is to ascertain the downsides of RALP by focusing on complications and limitations of this approach. EVIDENCE ACQUISITION: A Medline search of the English-language literature was performed to identify all papers published since 2001 relating to RALP. Papers providing data on technical failures, complications, learning curve, or other downsides of RALP were considered. Of 412 papers identified, 68 were selected for review based on their relevance to the objective of this paper. EVIDENCE SYNTHESIS: RALP has the following principal downsides: (1) device failure occurs in 0.2-0.4% of cases; (2) assessment of functional outcome is unsatisfactory because of nonstandardised assessment techniques; (3) overall complication rates of RALP are low, although higher rates are noted when complications are reported using a standardised system; (4) long-term oncologic data and data on high-risk PCa are limited; (5) a steep learning curve exists, and although acceptable operative times can be achieved in <20 cases, positive surgical margin (PSM) rates may require experience with >80 cases before a plateau is achieved; (6) robotic assistance does not reduce the difficulty associated with obese patients and those with large prostates, middle lobes, or previous surgery, in whom outcomes are less satisfactory than in patients without such factors; (7) economic barriers prevent uniform dissemination of robotic technology. CONCLUSIONS: Many of the downsides of RALP identified in this paper can be addressed with longer-term data and more widespread adoption of standardised reporting measures. The significant learning curve should not be understated, and the expense of this technology continues to restrict access for many patients.