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Abstract Background Research into rare diseases is becoming more common, with recognition of the significant diagnostic and therapeutic care gaps. Registries are considered a key research methodology to address rare diseases. This report describes the structure of the Rare UK Diseases Study (RUDY) platform that aims to improve research processes and address many of the challenges of carrying out rare musculoskeletal disease research. RUDY is an internet-based platform with online registration, initial verbal consent, online capture of patient reported outcome measures and events within a dynamic consent framework. The database structure, security and governance framework are described. Results There have been 380 participants recruited into RUDY with completed questionnaire rates in excess of 50 %. There has been one withdrawal and two participants have amended their consent options. Conclusions The strengths of RUDY include low burden for the clinical team, low research administration costs with high participant recruitment and ease of data collection and access. This platform has the potential to be used as the model for other rare diseases globally.

Background: The optimal timing of radiotherapy (RT) after radical prostatectomy for prostate cancer has been uncertain. RADICALS-RT compared efficacy and safety of adjuvant RT versus an observation policy with salvage RT for prostate-specific antigen (PSA) failure., Patients and Methods: RADICALS-RT was a randomised controlled trial enrolling patients with ≥1 risk factor (pT3/4, Gleason 7-10, positive margins, preoperative PSA≥10 ng/ml) for recurrence after radical prostatectomy. Patients were randomised 1:1 to adjuvant RT ('Adjuvant-RT') or an observation policy with salvage RT for PSA failure ('Salvage-RT') defined as PSA≥0.1 ng/ml or three consecutive rises. Stratification factors were Gleason score, margin status, planned RT schedule (52.5 Gy/20 fractions or 66 Gy/33 fractions) and treatment centre. The primary outcome measure was freedom-from-distant-metastasis (FFDM), designed with 80% power to detect an improvement from 90% with Salvage-RT (control) to 95% at 10 years with Adjuvant-RT. Secondary outcome measures were biochemical progression-free survival, freedom from non-protocol hormone therapy, safety and patient-reported outcomes. Standard survival analysis methods were used; hazard ratio (HR)<1 favours Adjuvant-RT., Results: Between October 2007 and December 2016, 1396 participants from UK, Denmark, Canada and Ireland were randomised: 699 Salvage-RT, 697 Adjuvant-RT. Allocated groups were balanced with a median age of 65 years. Ninety-three percent (649/697) Adjuvant-RT reported RT within 6 months after randomisation; 39% (270/699) Salvage-RT reported RT during follow-up. Median follow-up was 7.8 years. With 80 distant metastasis events, 10-year FFDM was 93% for Adjuvant-RT and 90% for Salvage-RT: HR=0.68 [95% confidence interval (CI) 0.43-1.07, P=0.095]. Of 109 deaths, 17 were due to prostate cancer. Overall survival was not improved (HR=0.980, 95% CI 0.667-1.440, P=0.917). Adjuvant-RT reported worse urinary and faecal incontinence 1 year after randomisation (P=0.001); faecal incontinence remained significant after 10 years (P=0.017)., Conclusion: Long-term results from RADICALS-RT confirm adjuvant RT after radical prostatectomy increases the risk of urinary and bowel morbidity, but does not meaningfully improve disease control. An observation policy with salvage RT for PSA failure should be the current standard after radical prostatectomy., Trial Identification: RADICALS, RADICALS-RT, ISRCTN40814031, NCT00541047., (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Context: Treatment choice for localised prostate cancer remains a significant challenge for patients and clinicians, with uncertainty over decisions potentially leading to conflict and regret. There is a need to further understand the prevalence and prognostic factors of decision regret to improve patient quality of life., Objective: To generate the best estimates for the prevalence of significant decision regret localised prostate cancer patients, and to investigate prognostic patient, oncological, and treatment factors associated with regret., Evidence Acquisition: We performed a systematic search of MEDLINE, Embase, and PsychINFO databases including studies evaluating the prevalence or patient, treatment, or oncological prognostic factors in localised prostate cancer patients. A pooled prevalence of significant regret was calculated with the formal prognostic factor evaluation conducted per factor identified., Evidence Synthesis: Significant decision regret was present in a pooled 20% (95% confidence interval 16-23) of patients across 14 studies and 17883 patients. This was lower in active surveillance (13%), with little difference between those who underwent radiotherapy (19%) and those who underwent prostatectomy (18%). Evaluation of individual prognostic factors demonstrated higher regret in those with poorer post-treatment bowel, sexual, and urinary function; decreased involvement in the decision-making process; and Black ethnicity. However, evidence remains conflicting, with low or moderate certainty of findings., Conclusions: A significant proportion of men experience decision regret after a localised prostate cancer diagnosis. Monitoring those with increased functional symptoms and improving patient involvement in the decision-making process through education and decision aids may reduce regret., Patient Summary: We looked at how common regret in treatment decisions is after treatment for early-stage prostate cancer and factors linked with this. We found that one in five regret their decision, with those who had experienced side effects or were less involved in the decision-making process more likely to have regret. By addressing these, clinicians could reduce regret and improve quality of life., (Copyright © 2023 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Introduction: A prospective cohort study comparing peri- and postoperative outcomes for patients with predominantly anterior prostate cancer (APC) identified preoperatively against non-anterior prostate cancer (NAPC) treated via robotic-assisted radical prostatectomy (RARP)., Patients and Methods: Of the 757 RARP's completed between January 2016 and April 2018, two comparative cohorts for anterior and an equivalent group of non-anterior prostate tumours each consisting of 152 patients were compared against each other. Data were collected on the following variables: patient age; operating consultant; preoperative PSA, ISUP grade, degree of nerve sparing; tumour staging; presence and location of positive surgical margins; PSA density, postoperative ISUP grade; treatment paradigm and postoperative PSA, erectile function, and continence outcomes with 2-year follow-up., Results: APCs were found to have significantly lower ISUP grading postoperatively; increased diagnosis via active surveillance over new diagnosis; more frequently undertaken bilateral nerve-sparing and long-term poorer continence outcomes at 18 and 24 months postoperatively ( p  < 0.05). Pre- and post-op PSA levels, erectile function, PSA density, positive surgical margins (PSM), age and tumour staging showed no significant differences between the APC and NAPC cohorts ( p  > 0.05)., Conclusion: The lower ISUP grading could indicate APC as overall being less aggressive than NAPC, whereas the poorer long-term continence outcomes require further investigating. The non-significant differences amongst tumour staging, PSA density, preoperative PSA levels and PSM rates suggest that APC may not be as significant as predicted in diagnostic evaluation. Overall, this study provides useful information on the growing literature of anterior prostate cancer. Being the largest comparative cohort study to date on APC post-RARP, these results indicate the true characteristics of anterior tumours and their functional outcomes to help improve education, patient expectations and management., Competing Interests: None declared., (© 2022 The Authors. BJUI Compass published by John Wiley & Sons Ltd on behalf of BJU International Company.)

Objective: To assess outcomes following Holmium Laser Enucleation of Prostate (HoLEP) in men with prostate volumes ≥150cc and compare this to men with prostate volumes ≤150 cc., Patients & Methods: We analyzed our prospective database of consecutive patients undergoing HoLEP in a single tertiary public hospital between October 2016 and January 2019. We excluded patients with clinically significant prostate cancer or neurogenic bladders. Preoperative prostate volume was measured on MRI or ultrasonography. Perioperative variables and functional outcomes were recorded., Results: Of 304 HoLEPs performed, we included 97 patients with prostate volume of ≥150 cc and 186 patients with prostate volume <150 cc. Comparing both cohorts (≥150 cc vs <150 cc): mean age was 71.5 vs 68.3 years, prostate volume 195 cc vs 93 cc, preoperative Qmax 9.6mL/s vs 10mL/s, American Urology Association Symptom Score (IPSS) 21 points vs 20.5 points; mean PSA 13.2µg/L vs 8.8µg/L; laser duration 86 vs 59 minutes; morcellation duration 29 vs 14 minutes; enucleated weight was 124 g vs 60 g. One patient (1%) from the ≥150 cc cohort required a surgical procedure for stress urinary incontinence, and none from the <150 cc cohort, but this did not achieve statistical significance (P = .12). There were no statistically significant differences in postoperative Qmax (32.3 vs 26.4 mL/s; P = .12), IPSS (5.9 points vs 7.3points; P = .23), mean PSA (3.9 µg/L vs 2.2 µg/L; P = .60), stricture incidence (1% vs 2.7%; P = .63), or significant stress urinary incontinence (4.1% vs 0.5%; P = .08)., Conclusion: Our large series demonstrates that HoLEP is safe and effective in patients with massive prostates (≥150 cc), with similar outcomes compared to patients with prostates <150 cc., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: Transrectal prostate biopsy (TRUSBx) holds a risk of prostate biopsy related sepsis. We discuss our step-wise strategies aiming to reduce this risk, including targeted antimicrobials and switching to a freehand transperineal approach (FHTPBx)., Subjects and Methods: This longitudinal cohort study included three groups. Group A underwent TRUSBx with empirical augmented antimicrobial prophylaxis; Group B underwent TRUSBx with targeted antimicrobial prophylaxis, based on rectal-swab cultures/sensitivity; Group C underwent FHTPBx with empirical antimicrobial prophylaxis. Post biopsy sepsis, defined according to the surviving sepsis campaign and confirmed with blood or urinary cultures, were determined and rates between groups were analysed using fisher's exact test., Results: Of all 1501 patients, 23 developed post biopsy sepsis; Group A (12/609, 2.0%), B (9/403, 2.2%), C (2/489, 0.4%). Targeted antimicrobials did not reduce the risk of post biopsy sepsis following TRUSBx (A vs B, 2.0% vs 2.2%; p = 0.82). Patients with antimicrobial-resistant rectal flora had an increased post biopsy sepsis rate following TRUSBx despite targeted antimicrobials (9.1% vs 1.1%, p = 0.003). Switching to FHTPBx reduced the risk of developing post biopsy sepsis (A vs C, 2% vs 0.4%, p = 0.03; B vs C, 2.2% vs 0.4%, p = 0.03)., Conclusions: Targeted antimicrobials based on rectal swab culture failed to reduce the overall risk of post biopsy sepsis, while FHTPBx nearly eliminated this risk. We recommend the use of transperineal prostate biopsies for all patients as the most effective method to reduce the risk of sepsis., (© 2021. Crown.)

Prostate biopsy is the definitive investigation to diagnose prostate cancer. The ideal procedure would be one that offers fast and efficient results safely as an outpatient procedure. Historically, transrectal ultrasound (TRUS) biopsy is considered the gold standard but transrectal biopsy can under-sample the anterior and apical regions of the prostate and is associated with a risk of prostate biopsy-related sepsis, which may require intensive care admission. Transperineal (TP) biopsy addresses the inefficient sampling of TRUS biopsy but historically has been done under general anaesthetic, which makes it difficult to incorporate into timed diagnostic pathways such as the National Health Service (NHS) 2-week cancer pathway. TRUS biopsy has remained the mainstay of clinical diagnosis because of its simplicity; however, the recent development of simpler local anaesthetic transperineal techniques has transformed outpatient biopsy practice. These techniques practically eliminate prostate biopsy-related sepsis, have a shallow learning curve and offer effective sampling of all areas of the prostate in an outpatient setting. The effectiveness of TP biopsy has been enhanced by the introduction of multiparametric MRI prior to biopsy, the use of PSA density for risk stratification in equivocal cases and combined with more efficient targeted and systematic biopsies techniques, such as the Ginsburg Protocol, has improved the tolerability and diagnostic yield of local anaesthetic TP biopsies, reducing the risk of complications from the oversampling associated with transperineal template mapping biopsies. Areas where the literature remains unclear is the optimum number of cores needed to detect clinically significant disease (CSD) in patients with a definable lesion on MRI, in particular, whether there is a need for systematic biopsy in the face of equivocal MRI findings to ensure no CSD is missed. The Covid-19 pandemic has had a profound impact on prostate cancer referrals and prostate biopsy techniques within the UK; prior to the pandemic 65% of all prostate biopsies were TRUS, since the pandemic the proportions have reversed such that now over 65% of all prostate biopsies in the NHS are transperineal., Competing Interests: Rick Popert is a Fellow on the NHS Innovation Accelerator. He receives honoraria for teaching and training from BXTAccelyon, the distributor of the PrecisionPoint Transperineal (TP) Access System. The other authors have nothing to disclose., (© 2021 Devetzis et al.)

Objectives: To assess the feasibility of local anaesthetic transperineal (LATP) technique using a single-freehand transperineal (TP) access device, and report initial prostate cancer (PCa) detection, infection rates, and tolerability., Patients and Methods: Observational study of a multicentre prospective cohort, including all consecutive cases. LATP was performed in three settings: (i) first biopsy in suspected PCa, (ii) confirmatory biopsies for active surveillance, and (iii) repeat biopsy in suspected PCa. All patients received pre-procedure antibiotics according to local hospital guidelines. Local anaesthesia was achieved by perineal skin infiltration and periprostatic nerve block without sedation. Ginsburg protocol principles were followed for systematic biopsies including cognitive magnetic resonance imaging-targeted biopsies when needed using the PrecisionPoint™ TP access device. Procedure-related complications and oncological outcomes were prospectively and consecutively collected. A validated questionnaire was used in a subset of centres to collect data on patient-reported outcome measures (PROMs)., Results: Some 1218 patients underwent LATP biopsies at 10 centres: 55%, 24%, and 21% for each of the three settings, respectively. Any grade PCa was diagnosed in 816 patients (67%), of which 634 (52% of total) had clinically significant disease. Two cases of sepsis were documented (0.16%) and urinary retention was observed in 19 patients (1.6%). PROMs were distributed to 419 patients, with a 56% response rate (n = 234). In these men, pain during the biopsy was described as either 'not at all' or 'a little' painful by 64% of patients. Haematuria was the most common reported symptom (77%). When exploring attitude to re-biopsy, 48% said it would be 'not a problem' and in contrast 8.1% would consider it a 'major problem'. Most of the patients (81%) described the biopsy as a 'minor or moderate procedure tolerable under local anaesthesia', while 5.6% perceived it as a 'major procedure that requires general anaesthesia'., Conclusion: Our data suggest that LATP biopsy using a TP access system mounted to the ultrasound probe achieves excellent PCa detection, with a very low sepsis rate, and is safe and well tolerated. We believe a randomised controlled trial comparing LATP with transrectal ultrasound-guided biopsy (TRUS) to investigate the relative trade-offs between each biopsy technique would be helpful., (© 2021 The Authors BJU International © 2021 BJU International Published by John Wiley & Sons Ltd.)

Context: Benign prostatic obstruction (BPO) is associated with sexual dysfunction. Furthermore, numerous BPO interventions may themselves impact sexual function., Objective: To perform a systematic review with network meta-analysis to evaluate how BPO interventions affect erectile function., Evidence Acquisition: Three databases were searched for randomised controlled trials (RCTs) comparing surgical interventions for BPO. The primary outcome was postoperative International Index of Erectile Function-5 (IIEF-5) score at ten time points up to 72 mo. A random-effects Bayesian network meta-analysis with meta-regression was performed. In comparison to monopolar transurethral resection (mTURP), the mean difference (MD) with 95% credible interval (CrI) and rank probability (rank p) were calculated for interventions. The mean baseline score was studied in meta-regression. τ 2 values were used to quantify heterogeneity., Evidence Synthesis: A total of 48 papers (33 RCTs, 5159 patients, 16 interventions) were included. Prostatic urethral lift (PUL) ranked highest at 1 mo (MD 3.88, 95% CrI -0.47 to 8.25; rank p = 0.742), 6 mo (MD 2.43, 95% CrI -0.72 to 5.62; rank p = 0.581), 12 mo (MD 2.94, 95% CrI -0.26 to 6.12, rank p = 0.782), and 24 mo (MD 3.63, 95% CrI 0.14 to 7.11; rank p = 0.948), at which point statistical significance was reached. At time points up to 60 mo, there were no statistically significant comparisons for other interventions. Analyses were not possible at 18, 48, or 72 mo. β did not reach statistical significance in meta-regression. τ 2 was highest at 1 mo (0.56) and 60 mo (0.55)., Conclusions: PUL ranked highly and resulted in erectile function improvement at 24 mo compared to mTURP, but direct evidence is lacking. We did not observe significant differences in erectile function following other interventions up to 60 mo. Owing to heterogeneity, our conclusions are weakest at 1 and 60 mo. Further RCTs comparing sexual function outcomes are recommended, such as PUL versus holmium laser or bipolar enucleation., Patient Summary: Different surgical treatments can be used to treat benign enlargement of the prostate causing urinary problems. We compared the effects of various treatments on erectile function at time points up to 5 years after surgery. Compared to surgical removal of some of the prostate gland (transurethral resection of the prostate, TURP), a technique called prostatic urethral lift resulted in better erectile function scores at 24 months. However, other treatments did not differ in their effect on erectile function., (Copyright © 2021 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Objective: To determine the risk of disease progression and conversion to active treatment following a negative biopsy while on active surveillance (AS) for prostate cancer (PCa)., Patients and Methods: Men on an AS programme at a single tertiary hospital (London, UK) between 2003 and 2018 with confirmed low-intermediate-risk PCa, Gleason Grade Group <3, clinical stage 30% positive cores, magnetic resonance imaging (MRI) Likert score >3/T3 or PSA level of >20 ng/mL. Conversion to treatment included radical or hormonal treatment., Results: Among the 460 eligible patients, 23% had negative follow-up biopsy findings. The median follow-up was 62 months, with one to two repeat biopsies and two MRIs per patient during that period. Negative biopsy findings at first repeat biopsy were associated with decreased risk of converting to active treatment (hazard ration [HR] 0.18, 95% confidence interval [CI] 0.09-0.37; P < 0.001), suspicion of disease progression (HR 0.56, 95% CI: 0.34-0.94; P = 0.029), and upgrading (HR 0.48, 95% CI 0.23-0.99; P = 0.047). Data are limited by fewer men with multiple follow-up biopsies., Conclusion: A negative biopsy finding at the first scheduled follow-up biopsy among men on AS for PCa was strongly associated with decreased risk of subsequent upgrading, clinical or radiological suspicion of disease progression, and conversion to active treatment. A less intense surveillance protocol should be considered for this cohort of patients., (© 2020 The Authors BJU International © 2020 BJU International.)

Background: Experiences of African/Afro-Caribbean men on active surveillance (AS) for prostate cancer (PCa) in the United Kingdom (UK) are not well documented. We compared follow-up appointments, adherence, and clinical outcomes among African/Afro-Caribbean men on AS at a high-volume UK hospital with other ethnicities., Methods: Men with confirmed low-intermediate risk Pca who attended the AS clinic (2005-2016) and had undergone ≥1 follow-up biopsy (n = 458) were included. Non-adherence (defined as >20% missed appointments), suspicion of disease progression (any upgrading, >30% positive cores, cT-stage > 3, PIRADS > 3), any upgrading from diagnostic biopsy and conversion to active treatment (prostatectomy, radiotherapy or hormone therapy) according to ethnicity (African/Afro-Caribbean versus other ethnicities) were assessed using multivariable regression analysis., Results: Twenty-three percent of eligible men were recorded as African/Afro-Caribbean, while the remainder were predominantly Caucasian. African/Afro-Caribbean men had slightly lower PSA at diagnosis (median 5.0 vs. 6.0 ng/mL) and more positive cores at diagnosis (median 2 vs. 1). They had a substantially higher rate of non-attendance at scheduled follow-up visits (24% vs. 10%, p < 0.001). Adjusted analyses suggest African/Afro-Caribbean men may be at increased risk of disease progression (hazard ratio [HR]: 1.38; 95% confidence interval [CI] 0.99-1.91, P = 0.054) and upgrading (HR: 1.29; 95% CI 0.87-1.92, P = 0.305), though neither reached statistical significance. No difference in risk of conversion to treatment was observed between ethnic groups (HR: 1.03; 95% CI 0.64-1.47, P = 0.873)., Conclusions: African/Afro-Caribbean men on AS for PCa in the UK are less likely to adhere to scheduled appointments, suggesting a more tailored service addressing their specific needs may be required. While African/Afro-Caribbean men were no more likely to convert to treatment than Caucasian/other men, findings of a potentially higher risk of disease progression signal the need for careful selection and monitoring of African/Afro-Caribbean men on AS. Larger prospective, multicentre studies with longer follow-up are required to provide more definitive conclusions.

Background: The routine clinical use of serum prostatic specific antigen (PSA) testing has allowed earlier detection of low-grade prostate cancer (PCa) with more favourable characteristics, leading to increased acceptance of management by active surveillance (AS). AS aims to avoid over treatment in men with low and intermediate-risk PCa and multiple governing bodies have described several AS protocols. This study provides a descriptive profile of the Guy's and St Thomas NHS Foundation Trust (GSTT) AS cohort as a platform for future research in AS pathways in PCa., Methods: Demographic and baseline characteristics were retrospectively collected in a database for patients at the GSTT AS clinic with prospective collection of follow-up data from 2012. Seven hundred eighty-eight men being monitored at GSTT with histologically confirmed intermediate-risk PCa, at least 1 follow-up appointment and diagnostic characteristics consistent with AS criteria were included in the profile. Descriptive statistics, Kaplan-Meier survival curves and multivariable Cox proportion hazards regression models were used to characterize the cohort., Discussion: A relatively large proportion of the cohort includes men of African/Afro-Caribbean descent (22%). More frequent use of magnetic resonance imaging and trans-perineal biopsies at diagnosis was observed among patients diagnosed after 2012. Those who underwent trans-rectal ultrasound diagnostic biopsy received their first surveillance biopsy 20 months earlier than those who underwent trans-perineal diagnostic biopsy. At 3 years, 76.1% men remained treatment free. Predictors of treatment progression included Gleason score 3 + 4 (Hazard ratio (HR): 2.41, 95% Confidence interval (CI): 1.79-3.26) and more than 2 positive cores taken at biopsy (HR: 2.65, CI: 1.94-3.62). A decreased risk of progressing to treatment was seen among men diagnosed after 2012 (HR: 0.72, CI: 0.53-0.98)., Conclusion: An organised biopsy surveillance approach, via two different AS pathways according to the patient's diagnostic method, can be seen within the GSTT cohort. Risk of patients progressing to treatment has decreased in the period since 2012 compared with the prior period with more than half of the cohort remaining treatment free at 5 years, highlighting that the fundamental aims of AS at GSTT are being met. Thus, this cohort is a good resource to investigate the AS treatment pathway.

Background: Salvage radical prostatectomy (sRP) historically yields poor functional outcomes and high complication rates. However, recent reports on robotic sRP show improved results. Our objectives were to evaluate sRP oncological outcomes and predictors of positive margins and biochemical recurrence (BCR)., Methods: We retrospectively collected data of sRP for recurrent prostate cancer after local nonsurgical treatment at 18 tertiary referral centers in United States, Australia and Europe, from 2000 to 2016. SM and BCR were evaluated in a univariate and multivariable analysis. Overall and cancer-specific survival were also assessed., Results: We included 414 cases, 63.5% of them performed after radiotherapy. Before sRP the majority of patients had biopsy Gleason score (GS) ≤7 (55.5%) and imaging negative or with prostatic bed involvement only (93.3%). Final pathology showed aggressive histology in 39.7% (GS ≥9 27.6%), with 52.9% having ≥pT3 disease and 16% pN+. SM was positive in 29.7%. Five years BCR-Free, cancer-specific survival and OS were 56.7%, 97.7% and 92.1%, respectively. On multivariable analysis pathological T (pT3a odds ratio [OR] 2.939, 95% confidence interval [CI] 1.469-5.879; ≥pT3b OR 2.428-95% CI 1.333-4.423) and N stage (pN1 OR 2.871, 95% CI 1.503-5.897) were independent predictors of positive margins. Pathological T stage ≥T3b (OR 2.348 95% CI 1.338-4.117) and GS (up to OR 7.183, 95% CI 1.906-27.068 for GS >8) were independent predictors for BCR. Limitations include the retrospective nature of the study and limited follow-up., Conclusions: In a contemporary series, sRP showed promising oncological control in the medium term despite aggressive pathological features. BCR risk increased in case of locally advanced disease and higher GS. Future studies are needed to confirm our findings., (Copyright © 2020. Published by Elsevier Inc.)

Purpose: To compare the toxicity profile and oncological outcome of salvage radical prostatectomy following focal therapy versus salvage radical prostatectomy after radiation therapies (external beam radiation therapy or brachytherapy)., Materials and Methods: Data concerning all men undergoing salvage radical prostatectomy for recurrent prostate cancer after either focal therapy, external beam radiation therapy or brachytherapy were retrospectively collected from 4 high volume surgical centers. The primary outcome measure of the study was toxicity of salvage radical prostatectomy characterized by any 30-day postoperative Clavien-Dindo complication rate, 12-month continence rate and 12-month potency rate. The secondary outcome was oncological outcome after salvage radical prostatectomy including positive margin rate and 12-month biochemical recurrence rate. Biochemical recurrence was estimated using Kaplan-Meier methods and significant differences were calculated using a log rank test. Median followup was 29.5 months., Results: Between April 2007 and September 2018, 185 patients underwent salvage radical prostatectomy of whom 95 had salvage radical prostatectomy after focal therapy and 90 had salvage radical prostatectomy after radiation therapy (external beam radiation therapy or brachytherapy). Salvage radical prostatectomy after radiation therapy was associated with a significantly higher 30-day Clavien-Dindo I-IV complication rate (34% vs 5%, p <0.001). At 12 months following surgery, patients undergoing salvage radical prostatectomy after focal therapy had significantly better continence (83% pad-free vs 49%) while potency outcomes were similar (14% vs 11%). Men undergoing salvage radical prostatectomy after radiation therapy had a significantly higher stage and grade of disease together with a higher positive surgical margin rate (37% vs 13%, p=0.001). The 3-year biochemical recurrence after focal therapy was 35% compared to 32% after radiation therapy (p=0.76). In multivariable analysis, men undergoing salvage radical prostatectomy after focal therapy experienced a higher risk of biochemical recurrence (HR 0.36, 95% CI 0.16-0.82, p=0.02)., Conclusions: This multicenter study demonstrates the toxicity of salvage radical prostatectomy in terms of perioperative complications and long-term urinary continence recovery is dependent on initial primary prostate cancer therapy received with men undergoing salvage radical prostatectomy after focal therapy experiencing lower postoperative complication rates and better urinary continence outcomes.

Objectives: To determine the safety of urological admissions and procedures during the height of the COVID-19 pandemic using "hot" and "cold" sites. The secondary objective is to determine risk factors of contracting COVID-19 within our cohort., Patients and Methods: A retrospective cohort study of all consecutive patients admitted from March 1 to May 31, 2020 at a high-volume tertiary urology department in London, United Kingdom. Elective surgery was carried out at a "cold" site requiring a negative COVID-19 swab 72-hours prior to admission and patients were required to self-isolate for 14-days preoperatively, while all acute admissions were admitted to the "hot" site.Complications related to COVID-19 were presented as percentages. Risk factors for developing COVID-19 infection were determined using multivariate logistic regression analysis., Results: A total of 611 patients, 451 (73.8%) male and 160 (26.2%) female, with a median age of 57 (interquartile range 44-70) were admitted under the urology team; 101 (16.5%) on the "cold" site and 510 (83.5%) on the "hot" site. Procedures were performed in 495 patients of which eight (1.6%) contracted COVID-19 postoperatively with one (0.2%) postoperative mortality due to COVID-19. Overall, COVID-19 was detected in 20 (3.3%) patients with two (0.3%) deaths. Length of stay was associated with contracting COVID-19 in our cohort (OR 1.25, 95% CI 1.13-1.39)., Conclusions: Continuation of urological procedures using "hot" and "cold" sites throughout the COVID-19 pandemic was safe practice, although the risk of COVID-19 remained and is underlined by a postoperative mortality., Competing Interests: The Authors do not declare any conflict of interest. Funding has been provided the department of Life Sciences and Medicine, King’s College London., (© 2021 The Authors. BJUI Compass published by John Wiley & Sons Ltd on behalf of BJU International Company.)

Background: The optimal timing of radiotherapy after radical prostatectomy for prostate cancer is uncertain. We aimed to compare the efficacy and safety of adjuvant radiotherapy versus an observation policy with salvage radiotherapy for prostate-specific antigen (PSA) biochemical progression., Methods: We did a randomised controlled trial enrolling patients with at least one risk factor (pathological T-stage 3 or 4, Gleason score of 7-10, positive margins, or preoperative PSA ≥10 ng/mL) for biochemical progression after radical prostatectomy (RADICALS-RT). The study took place in trial-accredited centres in Canada, Denmark, Ireland, and the UK. Patients were randomly assigned in a 1:1 ratio to adjuvant radiotherapy or an observation policy with salvage radiotherapy for PSA biochemical progression (PSA ≥0·1 ng/mL or three consecutive rises). Masking was not deemed feasible. Stratification factors were Gleason score, margin status, planned radiotherapy schedule (52·5 Gy in 20 fractions or 66 Gy in 33 fractions), and centre. The primary outcome measure was freedom from distant metastases, designed with 80% power to detect an improvement from 90% with salvage radiotherapy (control) to 95% at 10 years with adjuvant radiotherapy. We report on biochemical progression-free survival, freedom from non-protocol hormone therapy, safety, and patient-reported outcomes. Standard survival analysis methods were used. A hazard ratio (HR) of less than 1 favoured adjuvant radiotherapy. This study is registered with ClinicalTrials.gov, NCT00541047., Findings: Between Nov 22, 2007, and Dec 30, 2016, 1396 patients were randomly assigned, 699 (50%) to salvage radiotherapy and 697 (50%) to adjuvant radiotherapy. Allocated groups were balanced with a median age of 65 years (IQR 60-68). Median follow-up was 4·9 years (IQR 3·0-6·1). 649 (93%) of 697 participants in the adjuvant radiotherapy group reported radiotherapy within 6 months; 228 (33%) of 699 in the salvage radiotherapy group reported radiotherapy within 8 years after randomisation. With 169 events, 5-year biochemical progression-free survival was 85% for those in the adjuvant radiotherapy group and 88% for those in the salvage radiotherapy group (HR 1·10, 95% CI 0·81-1·49; p=0·56). Freedom from non-protocol hormone therapy at 5 years was 93% for those in the adjuvant radiotherapy group versus 92% for those in the salvage radiotherapy group (HR 0·88, 95% CI 0·58-1·33; p=0·53). Self-reported urinary incontinence was worse at 1 year for those in the adjuvant radiotherapy group (mean score 4·8 vs 4·0; p=0·0023). Grade 3-4 urethral stricture within 2 years was reported in 6% of individuals in the adjuvant radiotherapy group versus 4% in the salvage radiotherapy group (p=0·020)., Interpretation: These initial results do not support routine administration of adjuvant radiotherapy after radical prostatectomy. Adjuvant radiotherapy increases the risk of urinary morbidity. An observation policy with salvage radiotherapy for PSA biochemical progression should be the current standard after radical prostatectomy., Funding: Cancer Research UK, MRC Clinical Trials Unit, and Canadian Cancer Society., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Objectives: To assess whether targeted cognitive freehand-assisted transperineal biopsies using a Precisionpoint TM device still require additional systematic biopsies to avoid missing clinically significant prostate cancer, and to investigate the benefit of a quadrant-only biopsy approach to analyse whether a quadrant or extended target of the quadrant containing the target only would have been equivalent to systematic biopsy., Patients and Methods: Patients underwent combined systematic mapping and targeted transperineal prostate biopsies at a single institution. Biopsies were performed using the Precisionpoint device (Perineologic, Cumberland, MD, USA) under either local anaesthetic (58%, 163/282), i.v. sedation (12%, 34/282) or general anaesthetic (30%, 85/282). A mean (range) of 24 (5-42) systematic and 4.2 (1-11) target cores were obtained. Magnetic resonance imaging (MRI) scans were reported using the Likert scale. Clinically significant cancer was defined as Gleason 7 or above. Histopathological results were correlated with the presence of an MRI abnormality within a spatial quadrant and the other adjoining or non-adjoining (opposite) quadrants. Histological concordance with radical prostatectomy specimens was analysed., Results: A total of 282 patients were included in this study. Their mean (range) age was 66.8 (36-80) years, median (range) prostate-specific antigen level 7.4 (0.91-116) ng/mL and mean prostate volume 45.8 (13-150) mL. In this cohort, 82% of cases (230/282) were primary biopsies and 18% (52/282) were patients on surveillance. In all, 69% of biopsies (195/282) were identified to have clinically significant disease (Gleason ≥3 + 4). Any cancer (Gleason ≥3 + 3) was found in 84% (237/282) of patients. Of patients with clinically significant disease, the target biopsies alone picked up 88% (171/195), with systematic biopsy picking up the additional 12% (24/195) that the target biopsies missed. This altered with Likert score; 73% of Likert score 3 disease was detected by target biopsy, 92% of Likert score 4 and 100% of Likert score 5. Target biopsies with additional same-quadrant-only systematic cores picked up 75% (18/24) of significant cancer that was missed on target only, found in the same quadrant as the target., Conclusion: Systematic biopsy is still an important tool when evaluating all patients referred for prostate biopsy, but the need is decreased with increasing suspicion on MRI. Patients with very high suspicion of prostate cancer (Likert score 5) may not require systematic cores, unless representative surrounding biopsies are required for other specific treatments (e.g. focal therapy, or operative planning). More prospective studies are needed to evaluate this in full., (© 2020 The Authors BJU International © 2020 BJU International Published by John Wiley & Sons Ltd.)

Objective: To evaluate the clinical and financial implications of a decade of prostate biopsies performed in the UK National Health Service (NHS) through the transrectal (TR) vs the transperineal (TP) route., Methods: We conducted an evaluation of the TR vs the TP biopsy approach in the context of 28 days post-procedure complications and readmissions. A secondary evaluation of burden of expenditure in NHS hospitals over the entire decade (2008-2019) was conducted through examination of national Hospital Episode Statistics (HES) data., Results: In this dataset of 486 467 prostate biopsies (387 879 TR and 98 588 TP biopsies), rates of infection and sepsis were higher for the TR compared to the TP cohort (0.53% vs 0.31%; P < 0.001, confidence interval 99% ). Rates of sepsis have more than doubled for TR biopsies in the last 2 years compared to the previous decade (1.12% vs 0.53%). Infective complications were the main reasons for readmissions in the TR cohort, whereas urinary retention was the predominant reason for readmission in the TP cohort. Over the last decade, non-elective (NEL) readmissions seem higher for the TP group; however, in the last 2 years these have reduced compared to the TR group (3.54% vs 3.74%). The cost estimates for NEL readmissions for the entire decade were £33,589,527.00 and £7,179,926.00 respectively, for TR and TP cohorts (P < 0.001). Estimated costs per patient readmission were £2,225.00 and £1,758.00 in the TR and TP groups (P < 0.001)., Conclusions: Evaluation of nearly half a million prostate biopsies in the NHS over the entire decade gives sufficient evidence for the distinct advantages of the TP route over the TR route in terms of reduced infections and burden of expenditure. In addition, there is a potential for savings both in upstream and downstream costs if biopsy is performed under a local anaesthetic., (© 2020 The Authors BJU International © 2020 BJU International Published by John Wiley & Sons Ltd.)

Purpose: To determine the impact on clinical management of patients with high-risk (HR) prostate cancer at diagnosis and patients with biochemical recurrence (BCR) using a new kit form of 68 Ga-prostate-specific membrane antigen (PSMA), namely tris(hydroxypyridinone) (THP)-PSMA, with positron emission tomography-computed tomography (PET-CT)., Methods: One hundred eighteen consecutive patients (50 HR, 68 BCR) had management plans documented at a multidisciplinary meeting before 68 Ga-THP-PSMA PET-CT. Patients underwent PET-CT scans 60-min post-injection of 68 Ga-THP-PSMA (mean 159 ± 21.2 MBq). Post-scan management plans, Gleason score, prostate-specific antigen (PSA) and PSA doubling time (PSAdt) were recorded., Results: HR group: 12/50 (24%) patients had management changed (9 inter-modality, 3 intra-modality). Patients with PSA < 20 μg/L had more frequent management changes (9/26, 34.6%) compared with PSA > 20 μg/L (3/24, 12.5%). Gleason scores > 8 were associated with detection of more nodal (4/16, 25% vs 5/31, 16.1%) and bone (2/16, 12.5% vs 2/31, 6.5%) metastases. BCR group: Clinical management changed in 23/68 (34%) patients (17 inter-modality, 6 intra-modality). Forty out of 68 (59%) scans were positive. Positivity rate increased with PSA level (PSA < 0.5 μg/L, 0%; PSA 0.5-1.0 μg/L, 35%; PSA 1.0-5.0 μg/L, 69%; PSA 5.0-10.0 μg/L, 91%), PSAdt of < 6 months (56% vs 45.7%) and Gleason score > 8 (78.9% vs 51.2%)., Conclusions: 68 Ga-THP-PSMA PET-CT influences clinical management in significant numbers of patient with HR prostate cancer pre-radical treatment and is associated with PSA. Management change also occurs in patients with BCR and is associated with PSA and Gleason score, despite lower scan positivity rates at low PSA levels < 0.5 μg/L.

Objectives: To evaluate the histopathological outcomes, morbidity and tolerability of freehand transperineal (TP) prostate biopsies using the PrecisionPoint™ access system (Perineologic, Cumberland, MD, USA) under local anaesthetic (LA) in the day surgery and outpatient environments, as systematic and targeted biopsies can be taken with the potential for reduced morbidity, particularly sepsis., Patients and Methods: In all, 176 patients underwent freehand TP prostate biopsies from May 2016 to November 2017. The procedure was carried out either under LA alone or with the addition of sedation. Magnetic resonance imaging (MRI) scans were reported using the Prostate Imaging-Reporting and Data System (PI-RADS), version 2. Tolerability was assessed using a visual analogue scale pain score for each procedural stage. Histopathological outcomes and complications were recorded., Results: The mean (range) age was 65 (36-83) years, median (range) prostate-specific antigen level was 7.9 (0.7-1374) ng/mL, and the mean (range) prostate volume 45 (15-157) mL. Biopsies were taken under LA alone (160 patients, 90%) or under LA with sedation (16, 9%). The main indication for biopsy was primary diagnosis (88.6%). In all, 91 (52%) patients underwent systematic TP biopsies (mean 24.2 cores). Cognitive MRI-targeted biopsies alone were performed in 45 patients (26%; mean 6.8 cores), and 40 (23%) had both systematic and target biopsies (mean 27.9 cores). Of the 75 patients who had primary systematic biopsies alone, 46 (61%) were positive, and 28/46 (60.9%) were diagnosed with clinically significant disease (Gleason ≥3+4). VAS pain scores were greatest during LA administration. There were five complications (2.8%, Clavien-Dindo Grade I/II). No patients developed urosepsis., Conclusions: Freehand TP biopsies using the PrecisionPoint access system is a safe, tolerable and effective method for systematic and targeted biopsies under LA in the outpatient setting. It has replaced transrectal biopsies in our centre and has potential to transform practice., (© 2018 The Authors BJU International © 2018 BJU International.)

Purpose: Salvage radical prostatectomy has historically yielded a poor functional outcome and a high complication rate. However, recent reports of robotic salvage radical prostatectomy have demonstrated improved results. In this study we assessed salvage radical prostatectomy functional outcomes and complications when comparing robotic and open approaches., Materials and Methods: We retrospectively collected data on salvage radical prostatectomy for recurrent prostate cancer after local nonsurgical treatment at 18 tertiary referral centers from 2000 to 2016. The Clavien-Dindo classification was applied to classify complications. Complications and functional outcomes were evaluated by univariable and multivariable analysis., Results: We included 395 salvage radical prostatectomies, of which 186 were open and 209 were robotic. Robotic salvage radical prostatectomy yielded lower blood loss and a shorter hospital stay (each p <0.0001). No significant difference emerged in the incidence of major and overall complications (10.1%, p=0.16, and 34.9%, p=0.67), including an overall low risk of rectal injury and fistula (1.58% and 2.02%, respectively). However, anastomotic stricture was more frequent for open salvage radical prostatectomy (16.57% vs 7.66%, p <0.01). Overall 24.6% of patients had had severe incontinence, defined as 3 or more pads per day, for 12 or 6 months. On multivariable analysis robotic salvage radical prostatectomy was an independent predictor of continence preservation (OR 0.411, 95% CI 0.232-0.727, p=0.022). Limitations include the retrospective nature of the study and the absence of a standardized surgical technique., Conclusions: In this contemporary series to our knowledge salvage radical prostatectomy showed a low risk of major complications and better functional outcomes than previously reported. Robotic salvage radical prostatectomy may reduce anastomotic stricture, blood loss and hospital stay, and improve continence outcomes.

Background: Researchers remain divided on the major causes of dropout from active surveillance (AS), with rates of up to 38% among men with no evidence of prostate cancer (PC) progression., Objective: To develop and evaluate an educational intervention in terms of adherence to AS among men with low- to intermediate-risk PC., Design, Setting, and Participants: We first carried out focus group discussions with men who had remained on and dropped out of AS to inform an intervention to increase adherence to AS. A total of 255 consecutive men who had selected AS were then recruited to either standard care (written information and access to a nurse specialist) or standard care and the intervention., Intervention: An educational seminar was designed by patients and clinicians including information on imaging, biopsy techniques, understanding pathology, large AS cohorts - mortality and morbidity risk and diet and lifestyle advice., Outcome Measurements and Statistical Analysis: The proportion of men dropping out of AS for reasons other than disease progression was assessed at 1 and 5yr after AS selection using multivariate logistic regression., Results and Limitations: Common themes influencing decision-making by men on AS were identified: (1) clinical consistency; (2) information; and (3) lifestyle advice. Addition of an educational seminar led to significantly fewer men dropping out of AS: at 1 and 5yr the dropout rate was 25% and 42%, respectively, in the standard care group, compared to 11% and 22% (p=0.001) in the intervention group. In the intervention group, 18 men failed to attend the seminar., Conclusions: The AS dropout rate was halved following a single educational seminar delivered to groups of men with intermediate- or low-risk PC, even at 5yr., Patient Summary: Men on active surveillance (AS) for prostate cancer feel more supported when provided with an educational seminar within 3 mo of their treatment choice. The seminar halved the number of men dropping-out of AS, even at 5yr., (Copyright © 2018 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Aim: To describe the authors' experience with prostate artery embolisation (PAE) to treat lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) or refractory haematuria of prostatic origin (RHOPA)., Materials and Methods: PAE was attempted in 159 patients. Procedural details, pre/post-PAE symptom scores, and pre/post-PAE magnetic resonance imaging (MRI) data were recorded. Statistical analysis was performed to determine clinical outcomes and factors predicting clinical success., Results: Technical success was achieved in 156 patients. In patients with LUTS, the International Prostate Symptom Score (IPSS) improved from a mean of 22 at baseline to 9.5 at 6-months post-PAE, then to 10.7, 10, 11.3, and 11 at 1, 2, 3, and 4 years. The quality of life (QoL) score improved from 4.6 at baseline to 2, 2.2, 2.4, 3.1, and 2.5 at the same time points. The International Index of Erectile Function (IIEF-5) scores remained stable. There was no significant difference in IPSS between bilateral or unilateral embolisation to 2 years, or between BPH alone or BPH with biopsy-proven prostate cancer to 3 years post-PAE. Percentage improvement in IPSS at 1 year correlated with percentage reduction in prostate volume on first post-PAE MRI. Percentage improvement in IPSS at 3 years correlated with initial IPSS. PAE facilitated urinary catheter removal in 13/24 patients in retention. PAE controlled bleeding in 12/12 patients with RHOPA., Conclusion: PAE is safe and effective in the management of symptomatic BPH. Patients with the highest baseline IPSS and reduction in prostate volume on first post-PAE MRI are likely to derive most benefit from embolisation., (Copyright © 2019 The Royal College of Radiologists. All rights reserved.)

Purpose: To develop and internally validate a nomogram using biparametric magnetic resonance imaging (B-MRI)-derived variables for the prediction of prostate cancer at transperineal sector-guided prostate biopsy (TPSB)., Subjects/patients and Methods: Consecutive patients referred to our institution with raised prostate-specific antigen (PSA), abnormal prostate examination, or persistent suspicion of prostate cancer after previous transrectal biopsy between July 2012 and November 2015 were reviewed from a prospective database. All patients underwent prebiopsy B-MRI with T2-weighted and diffusion-weighted imaging sequences, followed by 24 to 40 core TPSB with additional targeted cores using cognitive registration. Univariable and multivariable logistic regression analysis was used to determine predictors of prostate cancer outcomes. Multivariable coefficients were used to construct 2 MRI-based nomograms to predict any and significant (Gleason 4 or maximum cancer core length ≥6mm) prostate cancer at TPSB. Bootstrap resamples were used for internal validation. Accuracy was assessed by calculating the concordance index., Results: In total, 615 men were included in the study. Prostate cancer was diagnosed in 317 (51.5%) men with significant cancer diagnosed in 237 (38.5%) men. Age, Prostate Imaging Reporting and Data System (PI-RADS) score, PSA, PSA density, and primary biopsy were predictors of prostate cancer at TPSB on univariable analysis (P<0.0001). PSA showed strong correlation with PSA density and was excluded. The remaining variables were all independent predictors of prostate cancer on multivariable analysis (P<0.0001) and used to generate the nomograms. Both nomograms showed good discrimination for prostate cancer, with a concordance index of 87% for any cancer and 92% for significant disease. Using a nomogram-derived probability threshold of<15%, 111 (18.0%) biopsies can be saved, at the expense of 3 missed significant prostate cancers., Conclusions: These internally validated MR-based nomograms were able to accurately predict TPSB outcomes for prostate cancer, especially significant disease. Our findings support the combination of prebiopsy MRI results and clinical factors as part of the biopsy decision-making process., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Purpose: Prostate-specific antigen (PSA) density (PSAD) has potential to increase the diagnostic utility of PSA, yet has had poor uptake in clinical practice. We aimed to determine the diagnostic value of magnetic resonance imaging-derived PSAD (MR-PSAD) in predicting transperineal sector-guided prostate biopsy (TPSB) outcomes., Materials and Methods: Men presenting for primary TPSB from 2007 to 2014 were considered. Histological outcomes were assessed and defined as: presence of any cancer or significant cancer defined as presence of Gleason 4 and/or maximum tumour core length (MCCL) ≥ 4 mm (G4); or Gleason 4 and/or MCCL ≥ 6 mm (G6). Sensitivity, specificity and positive and negative predictive values were calculated, and receiver operating characteristics (ROC) curves were generated to compare MR-PSAD and PSA., Results: Six hundred fifty-nine men were evaluated with mean age 62.5 ± 9 years, median PSA 6.7 ng/ml (range 0.5-40.0), prostate volume 40 cc (range 7-187) and MR-PSAD 0.15 ng/ml/cc (range 0.019-1.3). ROC area under the curve (95% CI) was significantly better for MR-PSAD than PSA for all cancer definitions (p < 0.001): 0.73 (0.70-0.76) versus 0.61 (0.57-0.64) for any cancer; 0.75 (0.71-0.78) versus 0.66 (0.62-0.69) for G4; and 0.77 (0.74-0.80) versus 0.68 (0.64-0.71) for G6. Sensitivities for MR-PSAD < 0.1 ng/ml/cc were 85.0, 89.9 and 91.9% for any, G4 and G6 cancer, respectively., Conclusion: MR-PSAD may be better than total PSA in determining risk of positive biopsy outcome. Its use may improve risk stratification and reduce unnecessary biopsies.

Background/Aims/Objectives: Our aim was to evaluate the accuracy of systematic transperineal sector mapping biopsy (TPSMB) in predicting Gleason score (GS) at radical prostatectomy (RP), to compare its accuracy with standard transrectal ultrasound-guided biopsies (TRUS) and to establish the clinical impact of discordance between biopsies and RP on subsequent surgical management., Methods: Two hundred fifty-five patients from 2008 to 2013 who underwent RP following TPSMB (n = 204) or TRUS (n = 51), were included in this retrospective multi-institutional study. Concordance between biopsies and RPs GS was assessed both as percentages and with Cohen's Kappa coefficient. All mismatches between biopsies and RP were assessed for significance by 3 urologists using the Delphi method., Results: No differences were present among the groups. Concordance between biopsy and RP GS was 75.49% for TPSMB and 64.70% for TRUS. Kappa coefficient was 0.42 and 0.39 respectively. The Delphi method showed lower clinical impact of GS discordances for TPSMB with 7.8% of patients having significant change, thus being potentially more suitable for other treatment modalities, compared to TRUS (13.7%)., Conclusions: TPSMB had a higher accuracy for predicting the GS grade at RP showing superior GS concordance compared with standard TRUS. TPSMB provides an effective technique for systematic prostate biopsy to evaluate overall prostate cancer GS., (© 2017 S. Karger AG, Basel.)

Purpose: Systematic transrectal ultrasound biopsies have been the first-line biopsy strategy in men with suspected prostate cancer for over 30 years. Transperineal biopsy is an alternative approach but has been predominately reserved as a repeat biopsy strategy and not widely used as a first-line approach. This study evaluates the diagnostic and clinical outcomes of transperineal sector biopsy (TPSB) as a first-line biopsy strategy in the diagnosis and management of prostate cancer., Materials and Methods: A multi-institutional review of 402 consecutive patients who underwent primary transperineal sector biopsy. All patients had no prior history of prostate biopsy. TPSB was carried out as a day-case procedure under general or regional anaesthesia. The cancer detection rate, location and complications for all cases were evaluated., Results: Prostate cancer was identified in 249 patients (61.9%) and was comparably sited across anterior, middle and posterior sectors. The disease was clinically significant (Gleason 3+4 or &gt; 4mm maximum cancer length) in 187 patients (47%). Post biopsy urinary retention occurred in 6 patients (1.5%). Hematuria requiring overnight hospital admission occurred in 4 patients (1.0%). There were no cases of urosepsis., Conclusions: As a primary diagnostic strategy, TPSB is a safe and effective technique with high cancer detection rates. It also offers an attractive compromise to more extensive transperineal protocols, which can be more time-consuming and associated with higher morbidity.&nbsp.