Partial ablation versus radical prostatectomy in intermediate-risk prostate cancer:the PART feasibility RCT

Background Prostate cancer (PCa) is the most common cancer in men in the UK. Patients with intermediate-risk, clinically localised disease are offered radical treatments such as surgery or radiotherapy, which can result in severe side effects. A number of alternative partial ablation (PA) technologies that may reduce treatment burden are available; however the comparative effectiveness of these techniques has never been evaluated in a randomised controlled trial (RCT). Objectives To assess the feasibility of a RCT of PA using high-intensity focused ultrasound (HIFU) versus radical prostatectomy (RP) for intermediate-risk PCa and to test and optimise methods of data capture. Design We carried out a prospective, multicentre, open-label feasibility study to inform the design and conduct of a future RCT, involving a QuinteT Recruitment Intervention (QRI) to understand barriers to participation. Setting Five NHS hospitals in England. Participants Men with unilateral, intermediate-risk, clinically localised PCa. Interventions Radical prostatectomy compared with HIFU. Primary outcome measure The randomisation of 80 men. Secondary outcome measures Findings of the QRI and assessment of data capture methods. Results Eighty-seven patients consented to participate by 31 March 2017 and 82 men were randomised by 4 May 2017 (41 men to the RP arm and 41 to the HIFU arm). The QRI was conducted in two iterative phases: phase I identified a number of barriers to recruitment, including organisational challenges, lack of recruiter equipoise and difficulties communicating with patients about the study, and phase II comprised the development and delivery of tailored strategies to optimise recruitment, including group training, individual feedback and ‘tips’ documents. At the time of data extraction, on 10 October 2017, treatment data were available for 71 patients. Patient characteristics were similar at baseline and the rate of return of all clinical case report forms (CRFs) was 95%; the return rate of the patient-reported outcome measures (PROMs) questionnaire pack was 90.5%. Centres with specific long-standing expertise in offering HIFU as a routine NHS treatment option had lower recruitment rates (Basingstoke and Southampton) – with University College Hospital failing to enrol any participants – than centres offering HIFU in the trial context only. Conclusions Randomisation of men to a RCT comparing PA with radical treatments of the prostate is feasible. The QRI provided insights into the complexities of recruiting to this surgical trial and has highlighted a number of key lessons that are likely to be important if the study progresses to a main trial. A full RCT comparing clinical effectiveness, cost-effectiveness and quality-of-life outcomes between radical treatments and PA is now warranted

Men's Experiences on Active Surveillance: From Diagnosis to Discontinuation

Over 1.4 million men were diagnosed with prostate cancer worldwide in 2020. Due to increased early testing and detection, higher numbers are being diagnosed with low risk, localised prostate cancer. Active surveillance is the recommended treatment option for patients with low risk, localised prostate cancer, as it provides patients the opportunity to delay definitive treatments until clinically necessary whilst actively monitoring progression. However, there is no global consensus on eligibility criteria, best practice for management, or triggers for discontinuation, and therefore uptake, practice, and patient experiences may vary greatly across clinics and countries. In order to (a) understand patient experiences during active surveillance, (b) inform changes to active surveillance management that align with the needs of patients, and (c) identify critical research areas, consideration of the individual, social and ecological factors that influence patient experiences is required. To reach this aim, this thesis includes four studies using a range of methodologies to investigate patient experiences from diagnosis to active surveillance discontinuation. A fifth study focusing on enhancing methodology in this research domain is also included. Study One used qualitative methods to explore patient and partner experiences after low risk localised prostate cancer diagnosis as they navigated the treatment decision between active surveillance and definitive treatment. Study Two systematically reviewed the literature on patients’ unmet supportive care needs during active surveillance. Data for studies Three and Four were collected together using a mix of methodologies (quantitative survey and qualitative interviews). Given the outcomes of the systematic review (Study Two), in Study Three we investigated the unmet supportive care needs and psychological wellbeing of patients during active surveillance. In Study Four, we explored the personal and/or medical reasons patients discontinue active surveillance and move to definitive treatment. Finally, Study Five was a randomised trial embedded within Studies Three and Four to examine the influence of different unconditional monetary incentives on survey response rates. This body of research demonstrated that whilst patients on active surveillance generally report positive experiences and outcomes, a significant proportion report unmet supportive care needs across informational, sexual, physical, psychological, and patient care domains. Patients on active surveillance frequently report experiencing fear of cancer progression, appear to be greatly influenced by a variety of factors when navigating treatment decision (both at diagnosis and prior to discontinuation), and report uncertainty about active surveillance and their future. In addition, we observed that prostate cancer patients are no more likely to respond to long surveys when provided a larger unconditional monetary incentive ($20AUD) than a smaller unconditional monetary incentive ($10AUD). Further research to inform the development of supportive care interventions which directly address patient needs, align with their preferences, and consider their perspectives, is essential for improving active surveillance uptake, adherence, and overall experience for both patients and their partners/close allies. Doing so will require a strong engagement in research, which may be improved by using a variety of engagement strategies such as unconditional incentives, though further research is required.Thesis (Ph.D.) -- University of Adelaide, School of Medicine, 202

An Evidence-Based Proposal Supporting Prostate Specific Antigen in Protective Service Occupations

Clinical Problem: Prostate cancer is the most common cancer among men in the United States and is the leading cause of death (CDC, 2021). Etiology of prostate cancer remains unclear but in recent research it has been shown that there is an association between occupation and prostate cancer risk (Sritharan, et al., 2019). Specifically protective service occupations including firefighters, policeman and detectives, guards, and watchmen (Sritharan et al., 2019). Significance: With new evidence of risk factors, it is important that these individuals understand that they are at an increased risk of being diagnosed with prostate cancer. In 2018, New York State reported 15,714 cases of prostate cancer. With such a high incidence it is important that these individuals are participating in secondary prevention measures in the hopes that prostate cancer is caught early. PICOT Question: This EBP proposal is framed around the following PICOT question: Among persons who are in protective service occupations, what is the impact of a Nurse Practitioner led shared decision coaching program that utilizes a decision aid on improved knowledge of prostate cancer, confidence in shared decision making for prostate cancer screening and patient satisfaction over 12 weeks? Clinical Change: The change that will be implemented in this proposal is a nurse practitioner led shared decision coaching that will occur in a primary care setting with participants in protective service occupations. Education will be provided during the decision coaching and an opportunity to ask questions about prostate cancer and an individual’s specific risk factors will be allotted. Following the decision coaching the patient will be given the choice to have a PSA test ordered for them and if they decide to follow through with PSA testing, the nursing staff with take their blood draw then. Desired Outcome: The desired outcome of this evidence-based proposal will include improved knowledge of prostate cancer specifically anatomy and function, risk factors, screening, and symptoms of prostate cancer. Other outcomes include increase in PSA testing with improved confidence in decision making regarding the testing and improved satisfaction with the interaction between the patient and nurse practitioner. Summary: Through a review and synthesis of the literature, it was determined that the use of decision coaching and the use of decision aids are effective interventions for improving knowledge, satisfaction, and confidence