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INTRODUCTION AND OBJECTIVE: Randomised comparative outcomes are unavailable for focal therapy in localised prostate cancer. IP4 CHRONOS is an RCT aimed to optimise recruitment of patients dependent upon clinician and patient equipoise. METHOD(S): Patients with clinically significant localised prostate cancer could opt for IP4-CHRONOS-A or IP4-CHRONOS-B. IP4- CHRONOS-A randomised patients 1:1 between focal therapy(HIFU or cryotherapy) versus radical therapy(radiation or prostatectomy). Using a multi-arm-multistage(MAMS)design, IP4-CHRONOS-B randomised between focal alone(FTA) and focal combined with neoadjuvant medication (12 weeks of finasteride [FTF] or bicalutamide [FTB]). We report the pilot phase outcomes on feasibility of randomisation, early safety outcomes relative to treatment and genito-urinary functional outcomes following over 12 months treatment in IP4-CHRONOS-B. IP4-CHRONOS had ethics committee approval and was registered(ISRCTN17796995). RESULT(S): Following COVID-19 adjustments, IP4-CHRONOSA did not meet its feasibility target. Having randomised 36 patients via10 sites with a recruitment rate (95% CI) of 18% (13-23) & randomisation rate of 97%(86-100). IP4-CHRONOS-B did meet its target, randomising 64 patients across 7 sites with a recruitment rate of 43% (35-52) &randomisation rate of 100%(94-100). The only patients to withdraw were randomised to the radical arm of IP4-CHRONOS-A(4 [22%]) All patients in IP4-CHRONOS-B were compliant with neoadjuvant treatment.Only 1 patient reported CTCAE V4.0 grade>=3 adverse event(AE) in IP4-CHRONOS-A following radical treatment, another patient in each arm reported a serious adverse event(SAE) following treatment. 1 &3 patients reported an AE &SAE following FTB. 2 and 3 patients reported an AE &SAE following FTA. No patients reported any AE or SAE event following FTF. Figure 1 demonstrates generally well preserved genito-urinary function following focal treatment+/-neoadjuvant treatment. CONCLUSION(S): IP4-CHRONOS evaluated patient and physician equipoise regarding focal therapy. Traditional randomisation was not feasible due to strong patient preferences, while a MAMS RCT investigating the role of neoadjuvant agents combined with focal therapy was.
ABSTRACT
Background: Randomised comparative data is lacking for focal therapy in localised prostate cancer. Imperial Prostate 4 CHRONOS (IP4-CHRONOS) is an RCT designed to reflect patient and physician equipoise to maximise acceptance to randomisation. Methods: Patients and physicians could opt for CHRONOS-A or CHRONOS-B. CHRONOS-A randomised between focal therapy (HIFU/cryotherapy) and radical therapy (radiation/prostatectomy). Using a multi-arm-multistage design, CHRONOS-B randomised between focal and focal combined with neoadjuvant medication (3 months of either finasteride or bicalutamide). We report the pilot phase outcomes on feasibility of randomisation. IP4-CHRONOS had ethics committee approval and was registered (ISRCTN17796995). Results: Due to impact of COVID-19, the target for CHRONOS-A was modified from 60 to 36;36 patients were randomised over 24 months from 7 sites (Nov/2019-Nov/2021). CHRONOS-B randomised 64 patients over 14 months across 6 sites (Dec/2019-Feb/2021). Median (IQR) age and PSA (ng/ml) for CHRONOS-A were 69 (65-72) years and 6 (5-7) and for 66 (60.5-70) years and 6 (4-7) for CHRONOS-B, respectively. 34/36 (94%) and 60/64 (94%) had ISUP Grade Group > / = 2, respectively. 4/18 (22%) randomised to radical in CHRONOS-A withdrew consent;1/22 (5%) randomised to focal withdrew. In CHRONOS-B, only 1/21 (5%) randomised to focal alone, and another randomised to focal with neoadjuvant bicalutamide withdrew. A qualitative recruitment intervention partially improved accrual to CHRONOS-A. Conclusions: IP4-CHRONOS evaluated patient and physician equipoise regarding focal therapy. Randomising between focal and radical therapy is not feasible due to strong patient preferences. A multi-arm, multi-stage RCT investigating the role of neoadjuvant agents combined with focal therapy is feasible.
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Introduction: The coronavirus (COVID-19) pandemic of 2020 had a major impact on NHS services. From the 23rd of March 2020, the Urology Department in Basingstoke initiated telephone-led consultation clinics instead of face-to-face outpatient appointments, in accordance with U.K. guidance. Objectives: To evaluate patient experience and satisfaction following the introduction of remote (telephone) consultations during the COVID-19 pandemic. Patients and methods: The first 200 remote patient appointments between the 30th of March 2020 and the 16th of April 2020 were sent a postal questionnaire (19 questions relating to their experience and level of satisfaction with the interaction). Telephone consultations were conducted by 6 consultants, 3 registrars, and 2 specialist nurses. The patients were not prewarned to expect a questionnaire after the remote ap-pointment. The associated cost saving resulting from a switch from face-to-face appointments to remote telephone appointments was also calculated. Results: 100 out of the 200 patients responded within 1 month (response rate 50%). A total of 44% of the patients were new referrals, while 56% were follow-ups. Overall, the feedback was positive regarding the telephone consultation, with 88% rating the care received as excellent or very good. In addition, 90% would recommend a telephone consultation to family and friends. However, 35% would prefer in the future to have another telephone consultation rather than face-to-face consultation, with 46% preferring a face-to-face appointment in the future and 19% unsure. For new patients, the proportion wishing to have a face-to-face appointment, in the end, was unsurprisingly higher than it was for those undergoing a follow-up (39% vs. 7 %). In these 2 weeks, the cost reduction to the NHS from shifting from face-to-face consultation to telephone consultation was estimated to be £6500. Conclusions: Telephone urology clinics are a satisfactory alternative to face-to-face appointments for many of our patients now and beyond the COVID-19 pandemic. They are efficient, cost-effective, and feasible to undertake urological consultation and can be implemented successfully in selected patients. The feedback from this questionnaire would suggest that priority should be given to face-to-face appointments for new patients and for complex follow-up appointments. Telephone follow-up appointments, however, are a good approach for the majority of patients.
ABSTRACT
Clinicians and patients must weigh the risk of treatment of prostate cancer during a global pandemic with the risk of cancer treatment delays. With the possibility of another peak, public confidence in cancer treatments requiring general anaesthetic will be critical. We report on the safety of performing focal therapy in the UK during the initial Covid-19 peak. Patients and Methods: Consecutive patients treated in 8 centres (23/3/20-23/7/20) were contacted at least 2 weeks after receiving focal ablative therapy. Treatment modalities included high intensity focused ultrasound (HIFU, n=90), cryotherapy (n=32) or irreversible electroporation (IRE, n=6). Results: 128/129 patients treated during the study period were successfully contacted. 107/ 128 (83.5%) underwent primary focal treatment, all had D'Amico intermediate or high-risk disease. National guidelines varied throughout the period. Treating sites requested formal shielding from May 2020 and done in 48/128 (37.5%). 20/128 (15.6%) underwent pre-operative swab tests and 5/128 (3.9%) pre-operative chest imaging. Two (1.6%) had intra-operative complications secondary to catheterisation, but none required overnight admission. No COVID-19 related post-treatment admissions were reported;2 (1.6%) had Covid-19 related symptoms but were not tested as symptoms spontaneously resolved. 3 were admitted for non- COVID-19 issues and one was directly due to treatment related clot retention resulting in the only reported Clavien-Dindo score >2 complication [Table 1]. Conclusions: Focal therapy for non-metastatic prostate cancer was a safe treatment option during a COVID-19 pandemic when appropriate precautions are taken and should be discussed with eligible patients.
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Objectives: BPH is a common condition in ageing men that can negatively impact quality of life. Surgical management is indicated when medical management is no longer effective. We compared the overall cost and capacity benefit of available surgical interventions for the relief of LUTS in BPH in three countries considering the post-COVID19 “new normal”. Methods: A recently published Markov model developed from a UK NHS perspective and used in NICE MTG49 was adapted to the Swedish and South African healthcare perspectives. Patients entered the model having a surgical procedure before transitioning to one of four health states, defined by whether patients suffer from one, both or none of the long-term complications captured in the model, namely urinary incontinence or erectile dysfunction. Surgical retreatment, complications and procedure-related resource use was also considered. Surgical interventions included Water Vapor Thermal Therapy (WVTT), Photoselective Vaporization of the Prostate (PVP), Prostatic Urethral Lift (PUL), Holmium Laser Enucleation of the Prostate (HoLEP) and current standard of care, Transurethral Resection of the Prostate (TURP). Due to local practice differences, not all technologies were modelled in all geographies. Results: In the UK, using a 4-year timeline, PVP and WVTT were associated with lowest costs (£2,421 and £2,466 respectively), followed by PUL (£2,994), TURP (£3,098) and HoLEP (£3,120). In Sweden, PVP was associated with lower costs (38,638kr) than TURP (39,801kr). In South Africa, WVTT was associated with lower costs (R58,882) than TURP (R82,939). WVTT, PUL and PVP had shorter procedure times (17.5-30, 30, 49.6 minutes, respectively) compared to TURP (66-90 minutes) and did not require hospitalization. Cost reductions were driven by shorter procedure durations and length of stay. Conclusions: WVTT and PVP were the joint lowest cost interventions over 4-years. Day-case procedures are of particular relevance in a post-COVID19 landscape.
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Background and Objective Following on from the Royal College of Surgeons (RCS) recommendation of 5th of April 2020 to perform computed tomography (CT) scan of the chest in patients presenting with an abdominal pain emergencies and undergoing an abdominal CT;comparison was made between a cohort of patients with a RCS-COVID recommended scan and a similar group of patients in the pre-COVID era. To evaluate the value of extending CT-KUB scan to include the chest area, in patients presenting to the emergency department with acute renal colic during the COVID-19 pandemic. Material and Methods Retrospective data included;initial presentation, COVID-19-related symptoms, dose length product (DLP), scan extension, Ground glass appearance (GGO), Wuhan corona virus swab polymerase chain reaction (PCR) test. Results A total of 100 patients underwent CT KUB in April 2020 (Group 1) with a similar number of patients from the pre-COVID-19 pandemic randomly selected from August to October 2019 (Group 2). Patients age ranged from 15 to 91 years with a median of 48 years in Group 1, whilst in Group 2 the range was 19 to 85 years with a median of 50 years. All patients in both groups initially presented with renal colic. No COVID-19-related respiratory manifestations were recorded. Nine patients from Group 1 had GGO identified in their chest CT with all of them returning with negative COVID-19 swabs. Interestingly there was almost the same number of stones diagnosed 49% (49/ 100) in Group 1 patients compared with 50% (23/5150/100) from Group 2. Conclusions Despite the RCS COVID CT scan recommendations, our study has demonstrated no significant additional value of extending the CT-KUB to include the chest area in renal colic patients with no respiratory manifestations. Further studies are recommended in order to validate these results.