Dataset Information

Prostatectomy versus radiotherapy for early-stage prostate cancer (PREPaRE) study: protocol for a mixed-methods study of treatment decision-making in men with localised prostate cancer.

ABSTRACT: BACKGROUND:Men diagnosed with localised prostate cancer (LPC) wanting curative treatment face a highly preference-sensitive choice between prostatectomy and radiotherapy, which offer similar cure rates but different side effects. This study aims to determine the information, decision-making needs and preferences of men with LPC choosing between robotic prostatectomy and standard external beam or stereotactic radiotherapy. METHODS AND ANALYSIS:This study will be conducted at a large public teaching hospital in Australia offering the choice between robotic prostatectomy and radiotherapy from early 2017. Men (20-30) diagnosed with LPC who want curative treatment and meet criteria for either treatment will be invited to participate. In this mixed-methods study, patients will complete semistructured interviews before and after attending a combined clinic in which they consult a urologist and a radiation oncologist regarding treatment and four questionnaires (one before treatment decision-making and three after) assessing demographic and clinical characteristics, involvement in decision-making, decisional conflict, satisfaction and regret. Combined clinic consultations will also be audio-recorded and clinicians will report their perceptions regarding patients' suitability for, openness to and preferences for each treatment. Qualitative data will be transcribed verbatim and thematically analysed and descriptive statistical analyses will explore quantitative decision-making outcomes, with comparison according to treatment choice. DISCUSSION:Results from this study will inform how to best support men diagnosed with LPC deciding which curative treatment option best suits their needs and may identify the need for and content required in a decision aid to support these men. ETHICS AND DISSEMINATION:All participants will provide written informed consent. Data will be rigorously managed in accordance with national legislation. Results will be disseminated via presentations to both scientific and layperson audiences and publications in peer-reviewed scientific journals.

SUBMITTER: Smith AB

PROVIDER: S-EPMC5722081 | biostudies-other | 2017 Nov

REPOSITORIES: biostudies-other

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Prostatectomy versus radiotherapy for early-stage prostate cancer (PREPaRE) study: protocol for a mixed-methods study of treatment decision-making in men with localised prostate cancer.

Smith Allan Ben AB Mancuso Pascal P Sidhom Mark M Wong Karen K Berry Megan M Rincones Orlando O Forstner Dion D Bokey Lesley L Girgis Afaf A

BMJ open 20171103 11

<h4>Background</h4>Men diagnosed with localised prostate cancer (LPC) wanting curative treatment face a highly preference-sensitive choice between prostatectomy and radiotherapy, which offer similar cure rates but different side effects. This study aims to determine the information, decision-making needs and preferences of men with LPC choosing between robotic prostatectomy and standard external beam or stereotactic radiotherapy.<h4>Methods and analysis</h4>This study will be conducted at a larg ...[more]

PMID: 29102996

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Project description:BackgroundMale stress urinary incontinence (SUI) is a known complication following surgical intervention on the prostate, particularly following surgery for prostate cancer. Effective surgical treatments for SUI include artificial urinary sphincter (AUS) and male urethral sling. Prior data suggest that men may forego available treatment despite bothersome symptoms. The objective was to explore how men who underwent surgical correction for post-prostatectomy SUI navigated SUI treatment decisions.MethodsMixed method study was employed. Semi-structured interviews, participant surveys and objective clinical assessment of SUI were performed among a group of men living with incontinence after prostate cancer surgery who underwent surgery for SUI at the University of California in 2017.ResultsEleven men were interviewed after consultation for SUI and all had complete quantitative clinical data. Surgery for SUI included AUS (n=8) and sling (n=3). There was a decrease in pads per day from 3.2 to 0.9 and no major complications. Most patients found that the impact on activities and their treating urologist were of great importance. Sexual and relationships played a variable role with some participants ranking these as "great deal of influence" and others "little or no influence". Participants who underwent AUS were more likely to cite a higher importance on "being very dry" in choosing that surgery while sling patients had more variable ranking of important factors. Participants found a variety of inputs helpful in hearing information about SUI treatment options.ConclusionsAmong a group of 11 men who underwent surgical correction for post-prostatectomy SUI, there were identifiable themes on how men make decisions, evaluate quality of life (QoL) changes and approach treatment options. Men value more than being dry with measures of individual success that can include sexual and relationship health. Furthermore the role of the Urologist remains crucial as patients relied heavily on input and discussion with their Urologist to assist in treatment decisions. These findings can be used to inform future studies of the experience of men with SUI.

Project description:ObjectivesReview and assess cost-effectiveness studies of robotic-assisted radical prostatectomy (RARP) for localised prostate cancer compared with open radical prostatectomy (ORP) and laparoscopic radical prostatectomy (LRP).DesignSystematic review.SettingPubMed, Embase, Scopus, International HTA database, the Centre for Reviews and Dissemination database and various HTA websites were searched (January 2005 to March 2021) to identify the eligible cost-effectiveness studies.ParticipantsCost-effectiveness, cost-utility, or cost-minimization analyses examining RARP versus ORP or LRP were included in this systematic review.InterventionsDifferent surgical approaches to treat localized prostate cancer: RARP compared with ORP and LRP.Primary and secondary outcome measuresA structured narrative synthesis was developed to summarize results of cost, effectiveness, and cost-effectiveness results (eg, incremental cost-effectiveness ratio [ICER]). Study quality was assessed using the Consensus on Health Economic Criteria Extended checklist. Application of medical device features were evaluated.ResultsTwelve studies met inclusion criteria, 11 of which were cost-utility analyses. Higher quality-adjusted life-years and higher costs were observed with RARP compared with ORP or LRP in 11 studies (91%). Among four studies comparing RARP with LRP, three reported RARP was dominant or cost-effective. Among ten studies comparing RARP with ORP, RARP was more cost-effective in five, not cost-effective in two, and inconclusive in three studies. Studies with longer time horizons tended to report favorable cost-effectiveness results for RARP. Nine studies (75%) were rated of moderate or good quality. Recommended medical device features were addressed to varying degrees within the literature as follows: capital investment included in most studies, dynamic pricing considered in about half, and learning curve and incremental innovation were poorly addressed.ConclusionsDespite study heterogeneity, RARP was more costly and effective compared with ORP and LRP in most studies and likely to be more cost-effective, particularly over a multiple year or lifetime time horizon. Further cost-effectiveness analyses for RARP that more thoroughly consider medical device features and use an appropriate time horizon are needed.Prospero registration numberCRD42021246811.

Project description:IntroductionRobot-assisted laparoscopic prostatectomy (RALP) offers potential cure for localised prostate cancer but is associated with considerable toxicity. Potency and urinary continence are improved when the neurovascular bundles (NVBs) are spared during a nerve spare (NS) RALP. There is reluctance, however, to perform NS RALP when there are concerns that the cancer extends beyond the capsule of the prostate into the NVB, as NS RALP in this instance increases the risk of a positive surgical margin (PSM). The NeuroSAFE technique involves intraoperative fresh-frozen section analysis of the posterolateral aspect of the prostate margin to assess whether cancer extends beyond the capsule. There is evidence from large observational studies that functional outcomes can be improved and PSM rates reduced when the NeuroSAFE technique is used during RALP. To date, however, there has been no randomised controlled trial (RCT) to substantiate this finding. The NeuroSAFE PROOF feasibility study is designed to assess whether it is feasible to randomise men to NeuroSAFE RALP versus a control arm of 'standard of practice' RALP.MethodsNeuroSAFE PROOF feasibility study will be a multicentre, single-blinded RCT with patients randomised 1:1 to either NeuroSAFE RALP (intervention) or standard RALP (control). Treatment allocation will occur after trial entry and consent. The primary outcome will be assessed as the successful accrual of 50 men at three sites over 15 months. Secondary outcomes will be used to aid subsequent power calculations for the definitive full-scale RCT and will include rates of NS; PSM; biochemical recurrence; adjuvant treatments; and patient-reported functional outcomes on potency, continence and quality of life.Ethics and disseminationNeuroSAFE PROOF has ethical approval (Regional Ethics Committee reference 17/LO/1978). NeuroSAFE PROOF is supported by National Institute for Healthcare Research Research for Patient Benefit funding (NIHR reference PB-PG-1216-20013). Findings will be made available through peer-reviewed publications.Trial registration numberNCT03317990.

Dataset Information

Prostatectomy versus radiotherapy for early-stage prostate cancer (PREPaRE) study: protocol for a mixed-methods study of treatment decision-making in men with localised prostate cancer.

Publications

Prostatectomy versus radiotherapy for early-stage prostate cancer (PREPaRE) study: protocol for a mixed-methods study of treatment decision-making in men with localised prostate cancer.

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