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PURPOSE: Multimodal therapy has improved survival in genitourinary rhabdomyosarcoma, a rare pediatric cancer. However, little is reported regarding postoperative complications and long-term urinary and sexual function and quality of life. MATERIALS AND METHODS: We reviewed records from 1970-2018 to identify patients with genitourinary rhabdomyosarcoma of the bladder, prostate, pelvis, vagina, and uterus. We assessed modes of therapy, and if surgical, the type of resection, reconstruction, and reoperation. Primary outcomes included urinary continence, urinary tract infection occurrence, and stone formation. We also surveyed patients older than 18 years for urinary and sexual function. RESULTS: Fifty-one patients were identified for the post-treatment outcomes cohort. All received chemotherapy, 46 (90.2%) underwent surgery, and 34 (67%) received radiation. Twenty-nine patients (56.9%) received trimodal therapy, 17 (33.3%) received chemotherapy/surgery, and 5 (9.8%) received chemotherapy/radiation. Twenty-six had up-front radical surgery (with staged continence mechanism creation); these patients had higher rates of continence, similar rates of urinary tract infection, and higher rates of stone formation compared to those who were organ-spared. A third (4/12) of organ-spared patients underwent additional corrective surgery. Thirty patients with genitourinary rhabdomyosarcoma were surveyed and 14 responded to questionnaires. Overall, urinary complaints were mild, but both male and female respondents reported significant sexual dysfunction. CONCLUSIONS: Organ-sparing treatment was more likely to predispose patients to high rates of additional reconstructive surgery due to compromised urological function. In survey results, both men and women reported poor sexual function, but the majority of patients remained satisfied with their urinary function.
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Neoplasias Pélvicas , Rabdomiossarcoma , Neoplasias da Bexiga Urinária , Criança , Humanos , Masculino , Feminino , Neoplasias da Bexiga Urinária/cirurgia , Qualidade de Vida , Bexiga Urinária/cirurgia , Cistectomia/métodos , Neoplasias Pélvicas/cirurgia , Rabdomiossarcoma/cirurgiaRESUMO
PURPOSE: Historically, robotic-assisted radical prostatectomy is accompanied by an inpatient hospital admission. The COVID-19 pandemic necessitated a transition to same-day discharge robotic-assisted radical prostatectomy in some centers to free up critically needed inpatient beds. This study aims to compare complications, total health care costs, and patient satisfaction for same-day discharge vs inpatient robotic-assisted radical prostatectomy. MATERIALS AND METHODS: We compared 392 consecutive robotic-assisted radical prostatectomies performed as same-day discharge (n = 206) vs inpatient (n = 186) from February 2020 to November 2022 at 2 academic medical centers. We utilized propensity score analysis to assess the impact of same-day discharge vs inpatient robotic-assisted radical prostatectomy on 30-day complications (primary outcome). Time-driven activity-based costing analysis was applied to compare total costs of robotic-assisted radical prostatectomy care, and we administered a validated Patient Satisfaction Outcome Questionnaire to compare satisfaction scores. RESULTS: Inpatient robotic-assisted radical prostatectomy patients were more likely to be older, self-reported Black race or Hispanic ethnicity, and have higher American Society of Anesthesiologists classification. Complication rates were nonsignificantly lower for same-day discharge vs inpatient robotic-assisted radical prostatectomy (OR 0.87, 95% CI 0.35 to 2.21; P = .8). Same-day discharge vs inpatient robotic-assisted radical prostatectomy demonstrated a $2106 (19%) overall cost reduction. Median satisfaction survey scores were similar, and a clinically significant difference can be excluded. CONCLUSIONS: Same-day discharge robotic-assisted radical prostatectomy is cost-effective and should be the preferred approach in appropriately selected patients.
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Satisfação do Paciente , Procedimentos Cirúrgicos Robóticos , Masculino , Humanos , Pacientes Internados , Alta do Paciente , Pandemias , Resultado do Tratamento , Prostatectomia , Custos de Cuidados de SaúdeRESUMO
PURPOSE: We sought to determine whether preoperative stricture length measurement affected the choice of procedure performed, its correlation to intraoperative stricture length, and postoperative outcomes. METHODS: The Collaborative of Reconstructive Robotic Ureteral Surgery (CORRUS) database was queried for patients undergoing robotic ureteral reconstructive surgery from 2013 to 2021 who had surgical stricture length measurement. From this cohort, we identified patients with and without preoperative stricture length measurement via retrograde pyelogram or antegrade nephrostogram. Outcomes evaluated included intraoperative complications, 30-day complications greater than Clavien-Dindo grade II, hardware-free status, and need for additional procedures. RESULTS: Of 153 patients with surgical stricture length measurements, 102 (66.7%) had preoperative radiographic measurement. No repair type was more likely to have preoperative measurement. The Pearson correlation coefficient between surgical and radiographic stricture length measurements was + 0.79. The average surgical measurement was 0.71 cm (± 1.52) longer than radiographic assessment. Those with preoperative imaging waited on average 5.0 months longer for surgery, but this finding was not statistically significant (p = 0.18). There was no statistically significant difference in intraoperative complications, 30-day complication rates, hardware-free status at last follow-up, or need for additional procedures between patients with and without preoperative measurement. The only significant predictive factor was preoperative stricture length on 30-day postoperative complications. CONCLUSIONS: Despite relatively high prevalence of preoperative radiographic stricture length measurement, there are few measures where it offers clinically meaningful diagnostic information towards the definitive surgical management of ureteral stricture disease.
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Procedimentos Cirúrgicos Robóticos , Cirurgia Plástica , Ureter , Doenças Ureterais , Obstrução Ureteral , Humanos , Constrição Patológica/cirurgia , Procedimentos Cirúrgicos Robóticos/métodos , Ureter/diagnóstico por imagem , Ureter/cirurgia , Obstrução Ureteral/diagnóstico por imagem , Obstrução Ureteral/cirurgia , Complicações Intraoperatórias , Estudos Retrospectivos , Resultado do TratamentoRESUMO
INTRODUCTION: Practice patterns around the use of urodynamic evaluation (UDS) for benign prostatic hyperplasia (BPH) surgery are largely undefined. As such, we investigated factors associated with the use of UDS for BPH. METHODS: We used American Board of Urology case log data from 2008 to 2020, to compare patient- and surgeon-sided factors associated with UDS utilization and BPH surgeries. We performed logistic regression models to identify factors independently associated with UDS usage for BPH. RESULTS: Among urologists performing UDS, the majority (80%) self-identified as general urologists and practiced in a private practice group (69%). Compared with urologists who performed no UDS, urologists who performed any UDS for BPH were more likely to be from the Mid-Atlantic (20.3% vs. 10.6%, p < 0.01) and practice in regions with populations of >1 000 000 (34.7% vs. 28.5%, p < 0.01). Overall, UDS utilization declined over time (odds ratio [OR]: 0.95 year-to-year, 95% confidence interval [CI]: 0.91-0.99). In adjusted analyses, the odds of performing UDS was higher among male (OR: 2.19, 95% CI: 1.17-4.09), older (OR: 1.05, 95% CI: 1.03-1.06), and female pelvic medicine and reconstructive surgery subspecialty (OR: 3.23, 95% CI: 2.01-5.2) urologists. Additionally, performing UDS for BPH was associated with higher BPH surgical case volume (OR: 1.004, 95% CI: 1.001-1.008). CONCLUSION: There is a significant practice variation in use of UDS for BPH. Although overall BPH surgeries are increasing, urologists are increasingly less likely to perform UDS for BPH. Specifically, urologists who perform UDS have significantly higher BPH case volume than those who do not perform UDS, suggesting that UDS usage may not factor into BPH surgery decision-making.
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Hiperplasia Prostática , Urologia , Humanos , Masculino , Feminino , Hiperplasia Prostática/cirurgia , Urodinâmica , Padrões de Prática Médica , UrologistasRESUMO
Count Me In (CMI) was launched in 2015 as a patient-driven research initiative aimed at accelerating the study of cancer genomics through direct participant engagement, electronic consent and open-access data sharing. It is an example of a large-scale direct-to-patient (DTP) research project which has since enrolled thousands of individuals. Within the broad scope of 'citizen science', DTP genomics research is defined here as a specific form of 'top-down' research endeavour developed and overseen by institutions within the traditional human subjects research context; in novel ways, it engages and recruits patients with defined diseases, consents them for medical information and biospecimens sharing, and stores and disseminates genomic information. Importantly, these projects simultaneously aim to empower participants in the research process while increasing sample size, particularly in rare disease states. Using CMI as a case study, this paper discusses how DTP genomics research raises new questions in the context of traditional human subjects research ethics, including issues surrounding participant selection, remote consent, privacy and return of results. It aims to demonstrate how current research ethics frameworks may be insufficient in this context, and that institutions, institutional review boards and investigators should be aware of these gaps and their role in ensuring the conduct of ethical, novel forms of research together with participants. Ultimately, a broader question is raised of whether the rhetoric of participatory genomics research advocates for an ethic of personal and social duty for contributing to the advancement of generalisable knowledge about health and disease.
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Genômica , Consentimento Livre e Esclarecido , Humanos , Ética em Pesquisa , Privacidade , Sujeitos da PesquisaRESUMO
Objective: Bladder neck contracture and vesicourethral anastomotic stenosis are difficult to manage endoscopically, and open repair is associated with high rates of incontinence. In recent years, there have been increasing reports of robotic-assisted bladder neck reconstruction in the literature. However, existing studies are small, heterogeneous case series. The objective of this study was to perform a systematic review of robotic-assisted bladder neck reconstruction to better evaluate patency and incontinence outcomes. Methods: We performed a systematic review of PubMed from first available date to May 2023 for all studies evaluating robotic-assisted reconstructive surgery of the bladder neck in adult men. Articles in non-English, author replies, editorials, pediatric-based studies, and reviews were excluded. Outcomes of interest were patency and incontinence rates, which were pooled when appropriate. Results: After identifying 158 articles on initial search, we included only ten studies that fit all aforementioned criteria for robotic-assisted bladder neck reconstruction. All were case series published from March 2018 to March 2022 ranging from six to 32 men, with the median follow-up of 5-23 months. A total of 119 patients were included in our analysis. A variety of etiologies and surgical techniques were described. Patency rates ranged from 50% to 100%, and pooled patency was 80% (95/119). De novo incontinence rates ranged from 0% to 33%, and pooled incontinence was 17% (8/47). Our findings were limited by small sample sizes, relatively short follow-ups, and heterogeneity between studies. Conclusion: Despite limitations, current available evidence suggests comparable patency outcomes and improved incontinence outcomes for robotic bladder neck reconstruction compared to open repair. Additional prospective studies with longer-term follow-ups are needed to confirm these findings.
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Background and objective: There is insufficient evidence on the oncologic risks of testosterone therapy for men with prostate cancer managed with active surveillance. We carried out a retrospective study to assess the effect of testosterone therapy on oncologic outcomes for men on active surveillance for prostate cancer. Methods: Surveillance, Epidemiology and End Results (SEER)-Medicare linked data were used to identify men diagnosed with prostate cancer from 2008 to 2017 who were managed with active surveillance and received testosterone (n = 167) or no testosterone (n = 6658) therapy. Outcomes included conversion from active surveillance to active treatment (radical prostatectomy, cryotherapy, radiation, or androgen deprivation therapy), prostate cancer-specific mortality, and overall mortality. Statistically significant factors on univariable analysis were included in a Cox proportional-hazards regression model for multivariable analysis. Key findings and limitations: The median age was 71 yr (interquartile range [IQR] 68-74) in the testosterone group and 72 yr (IQR 69-75) in the no-testosterone group, with corresponding median follow-up after prostate cancer diagnosis of 5.2 yr (IQR 3.4-7.8) and 4.7 yr (IQR 3.2-6.9). There were no prostate cancer-specific deaths in the testosterone group and 39 (0.6%) in the no-testosterone group. Testosterone therapy was not associated with conversion to active treatment (hazard ratio [HR] 0.66, 95% confidence interval [CI] 0.46-0.97; p = 0.033) or overall mortality (HR 1.02, 95% CI 0.68-1.53; p > 0.9). Conclusions and clinical implications: In the first population-based, nationally representative study of testosterone therapy for men on active surveillance for prostate cancer, testosterone therapy did not increase the risk of conversion to active therapy or worsen mortality. Prospective studies are needed to confirm these findings. Patient summary: For men on active surveillance for prostate cancer, we assessed the effect of testosterone therapy. We found that testosterone therapy did not increase the risk of proceeding to active therapy or of death from prostate cancer.
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OBJECTIVE: To evaluate the incidence of gender-affirming phalloplasty and postoperative complications in a large population-based dataset. METHODS: Retrospective cohort study was done using the California Department of Health Care Access and Information datasets which include patient-level data from all licensed hospitals, emergency departments, and ambulatory surgery facilities in California. Adult patients 18 years or older undergoing gender-affirming phalloplasty in California from January 1, 2009 to December 31, 2019 were included. We examined phalloplasty-related complications using International Classification of Disease diagnosis and procedure codes and Current Procedural Terminology codes. Unique record linkage number identifiers were used to follow patients longitudinally. Statistical analysis included Kaplan-Meier survival analysis and Cox proportional hazards analysis. RESULTS: We identified 766 patients who underwent gender-affirming phalloplasty in 23 facilities. Of 475 patients with record linkage numbers, 253 (55.3%) had subsequent re-presentations to the inpatient, emergency department, and ambulatory surgery settings related to phalloplasty complications. Survival analysis indicated that 50% of patients re-presented by 1year post-phalloplasty. Asian/Pacific Islander patients had lower risk of complications, and California residents had higher risk of complications. CONCLUSION: This population-based study confirms that gender-affirming phalloplasty has a high complication rate, and demonstrates for the first time an association with high rates of return to hospitals, emergency departments, and ambulatory surgery centers. These findings provide additional higher-level evidence that may aid patient counseling, shared surgical decision-making, and institutional and government policy.
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Faloplastia , Cirurgia de Readequação Sexual , Adulto , Humanos , Estudos Retrospectivos , Incidência , Complicações Pós-Operatórias/epidemiologia , Pacientes Internados , Cirurgia de Readequação Sexual/métodosRESUMO
Background: Sexual health is critical to overall health, yet sexual history taking is challenging. LGBTQ+ patients face additional barriers due to cis/heteronormativity from the medical system. We aimed to develop and pilot test a novel sexual history questionnaire called the Sexual Health Intake (SHI) form for patients of diverse genders and sexualities. Methods: The SHI comprises four pictogram-based questions about sexual contact at the mouth, anus, vaginal canal, and penis. We enrolled 100 sexually active, English-speaking adults from a gender-affirming surgery clinic and urology clinic from November 2022 to April 2023. All surveys were completed in the office. Patients also answered five feedback questions and 15 questions from the Patient-Reported Outcomes Measurement Information System Sexual Function and Satisfaction (PROMIS-SexFS) survey as a validated comparator. Results: One hundred patients aged 19-86 years representing an array of racial/ethnic groups, gender identities, and sexuality completed the study. Forms of sexual contact varied widely and included all possible combinations asked by the SHI. Feedback questions were answered favorably in domains of clinical utility, inclusiveness of identity and anatomy, and comprehensiveness of forms of sexual behavior. The SHI captured more positive responses than PROMIS-SexFS in corresponding questions about specific types of sexual activity. The SHI also asks about forms of sexual contact that are not addressed by PROMIS-SexFS, such as penis-to-clitoris. Conclusions: SHI is an inclusive, patient-directed tool to aid sexual history taking without cisnormative or heteronormative biases. The form was well received by a diverse group of participants and can be considered for use in the clinical setting.
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OBJECTIVE: To compare clinically significant prostate cancer detection with TP-TBx utilizing software vs cognitive fusion. It is established that MRI prior to prostate biopsy improves detection of clinically significant cancer (csPCa, Grade Group ≥2). MRI/US fusion targeted biopsy via a transperineal approach (TP-TBx) is increasing in utilization due to the clean percutaneous approach that greatly reduces postbiopsy infection. However, the comparative effectiveness of formal software fusion over cognitive fusion remains under studied. MATERIALS AND METHODS: We performed a retrospective multicenter study from June 2020 to July 2022 including age, race, prostate-specific antigen (PSA), prostate volume, PI-RADS, lesion size(s), number of cores sampled, indication (elevated PSA, prior negative, active surveillance) and anesthesia type. Surgeon preference determined use of cognitive (PrecisionPoint) vs software fusion techniques. Multivariable logistic regression determined factors associated with TP-TBx detection of csPCa. RESULTS: We identified 490 patients (201 cognitive, 289 software fusion) who underwent TP-TBx. Patient age, PSA, number of targets, and PI-RADS were similar (all P > .05). Software fusion TP-TBx had 4 [95% confidence interval (CI) 3-5] more (estimated median difference) systematic cores sampled. csPCa was detected in 44% of all patients. In adjusted analysis, cognitive vs software fusion was similar in detection of csPCa (odds ratio 1.46, 95% CI 0.82-2.58). CONCLUSION: Cognitive vs software fusion TP-TBx has similar csPCa detection, despite fewer systematic cores taken with cognitive fusion. The expense, additional time requirement, and similar outcomes of software fusion platforms confers higher value to cognitive TP-Bx.
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Neoplasias da Próstata , Humanos , Masculino , Cognição , Biópsia Guiada por Imagem/métodos , Imageamento por Ressonância Magnética/métodos , Próstata/diagnóstico por imagem , Próstata/patologia , Antígeno Prostático Específico , Neoplasias da Próstata/patologia , Estudos Retrospectivos , SoftwareRESUMO
Since the US Food and Drug Administration first approved robotic surgery for clinical use in 2000, it has gained widespread adoption across multiple surgical domains. While pediatric surgery has had a relatively slower adoption rate, robotic surgery has nonetheless grown in this context. This work traces the historical and regulatory aspects of pediatric robotic surgery, showing how it incorporated an existing robotic surgical system developed for adults; situates the technology within ethical frameworks for analyzing surgical innovation; and advocates for combined surgeon self-regulation and institutional oversight. Finally, the argument is made that there are key unmet technological needs pertaining to instrument size and adaptability secondary to pediatric robotic surgery's smaller market share and that clinicians and producers of robotic surgical systems should work to address these needs.
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Procedimentos Cirúrgicos Robóticos , Especialidades Cirúrgicas , Cirurgiões , Adulto , Criança , Humanos , Instalações de SaúdeRESUMO
The European Association of Urology and American Urological Association offer differing recommendations on the prostate biopsy approach to use to minimize infection. Current level 1 evidence demonstrates no difference in infectious complications.
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Urologia , Masculino , Humanos , Estados Unidos , Próstata , Biópsia/efeitos adversos , Sociedades MédicasRESUMO
OBJECTIVE: To determine surgical outcomes in a large of cohort men undergoing robotic-assisted posterior urethroplasty (RPU), which has been described in small series as a viable option. MATERIALS AND METHODS: We performed a retrospective review of all 105 men who underwent RPU from October 2014 to August 2022 at a single institution. We evaluated postoperative outcomes, including complications; surgical success defined as no need for reintervention; and incontinence requiring artificial urinary sphincter placement. We performed descriptive statistics and chi-square testing to determine if outcomes were associated with certain posterior urethral disease etiologies. RESULTS: Mean follow-up time was 18.7months. Over half of patients (57.1%) received prior pelvic radiation. The most common reconstructive techniques were excision and primary anastomosis (nâ¯=â¯45, 30.0%), resitting of the bladder neck (nâ¯=â¯26, 24.8%), Y-V plasty (nâ¯=â¯21, 20.0%), and buccal mucosal graft urethroplasty (nâ¯=â¯14, 13.3%). Forty-one patients (39.0%) required a combined abdominoperineal approach. Seven patients (6.7%) had ≥CD grade 3 complications within 30days. Thirty patients (28.6%) developed incontinence with subsequent artificial urinary sphincter placement. One-quarter (24.8%) of patients required at least one subsequent surgical reintervention. CONCLUSION: In the largest RPU cohort to date, surgical success rates were similar and continence rates were improved compared to open surgery and align with existing robotic series, adding to the growing body of evidence demonstrating advantages of RPU.
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Procedimentos de Cirurgia Plástica , Procedimentos Cirúrgicos Robóticos , Masculino , Humanos , Procedimentos Cirúrgicos Robóticos/efeitos adversos , Uretra/cirurgia , Bexiga Urinária , Pelve , Procedimentos de Cirurgia Plástica/efeitos adversosRESUMO
Acute testicular pain with no arterial flow on Doppler ultrasonography is highly consistent with testicular torsion. In adults, there are rare etiologies of testicular infarction other than torsion, including infection, vasculitis, and trauma. We describe a 41-year-old man with type 2 diabetes complicated by severe vasculopathy and positive SARS-CoV-2 status presenting with acute right testicular pain. Surgical exploration and pathology were concerning for arteriosclerosis and vasculitis. These observations suggest that medically complex patients presenting with acute testicular pain in the setting of COVID-19 infection could be at risk for ischemia; causes of testicular pain beyond torsion should be considered.
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OBJECTIVE: To use American Board of Urology (ABU) case log data to elucidate practice patterns for benign prostatic hyperplasia (BPH) surgery. Several surgical modalities have been introduced in recent decades causing significant practice variation. MATERIALS AND METHODS: We retrospectively analyzed ABU case logs from 2008-2021 to assess trends in BPH surgery. We created logistic regression models to identify surgeon-sided factors associated with utilization of each surgical modality. RESULTS: We identified 6,632 urologists who logged 73,884 surgeries for BPH. Transurethral resection of the prostate (TURP) was the most commonly performed BPH surgery in all but 1 year, and odds of performing a TURP increased year-over-year (OR 1.055, 95% CI [1.013,1.098], P = .010). The use of holmium laser enucleation of the prostate (HoLEP) did not change over time. HoLEP was more likely to be performed by urologists with higher BPH surgical volume (OR 1.017, CI [1.013, 1.021], P < .001) and with endourology subspecialization (OR 2.410, CI [1.45, 4.01], P = .001). Prostatic urethral lift (PUL) utilization increased significantly since its introduction in 2015 (OR 1.663, CI [1.540, 1.796], P < .001). PUL currently comprises over one third of all BPH surgeries logged. CONCLUSION: In the face of newer technologies, TURP remains the most common surgery for BPH in the United States. PUL has been rapidly adopted while HoLEP comprises a consistent minority of cases. Surgeon age, patient age, and urologist subspecialization were associated with use of certain BPH surgical approaches.
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Terapia a Laser , Lasers de Estado Sólido , Hiperplasia Prostática , Ressecção Transuretral da Próstata , Masculino , Humanos , Hiperplasia Prostática/cirurgia , Hiperplasia Prostática/complicações , Estudos Retrospectivos , Próstata , Endoscopia , Lasers de Estado Sólido/uso terapêutico , Resultado do TratamentoRESUMO
Background: Expert consensus recommends treatment of magnetic resonance imaging (MRI)-visible prostate cancer (PCa). Outcomes of partial-gland ablation (PGA) for MRI-invisible PCa remain unknown. Objective: To compare recurrence-free survival, adverse events, and health-related quality of life (HRQoL) outcomes following cryoablation of MRI-visible vs invisible PCa. Design setting and participants: We analyzed data for 75 men who underwent cryoablation therapy between January 2017 and January 2022. PCa identified on MRI-targeted and/or adjacent systematic biopsy cores was defined as MRI-visible, whereas PCa identified on systematic biopsy beyond the targeted zone was defined as MRI-invisible. Outcome measurements and statistical analysis: The primary outcome was recurrence at 12 mo after PGA, defined as the presence of clinically significant PCa (grade group [GG] ≥2) on surveillance biopsy. Adverse events were captured using the Clavien-Dindo classification and HRQoL was captured using the Expanded Prostate Cancer Index-Clinical Practice (EPIC-CP) tool. Results and limitations: Of the 58 men treated for MRI-visible and 17 treated for MRI-invisible lesions, 51 (88%) and 16 (94%), respectively, had at least one surveillance biopsy performed. There were no statistically significant differences in age, race, body mass index, biopsy GG, prostate-specific antigen, prostate volume, or treatment extent between the MRI-visible and MRI-invisible groups. Median follow-up was 44 mo (interquartile range 17-54) and did not significantly differ between the groups. The recurrence rate at 12 mo did not significantly differ between the groups (MRI-visible 39%, MRI-invisible 19%; p = 0.2), and log-rank survival analysis demonstrated no significant difference in recurrence-free survival (p = 0.15). Adverse event rates did not significantly differ (MRI-visible 29%, MRI-invisible 53%; p = 0.092); no man in the MRI-visible group had a Clavien-Dindo grade ≥III complication, while one subject in the MRI-invisible group had a Clavien-Dindo grade III complication. Median EPIC-CP urinary and sexual function scores were similar for the two groups at baseline and at 12 mo after PGA. Study limitations include the retrospective design and small sample size. Conclusions: We observed similar cancer control, adverse event, and HRQoL outcomes for MRI-visible versus MRI-invisible PCa in the first comparison of partial-gland cryoablation. Longer follow-up and external validation of our findings are needed to inform patient selection for PGA for MRI-invisible PCa. Patient summary: Patients with prostate cancer lesions that are not visible on magnetic resonance imaging (MRI) scans who undergo partial gland ablation may have similar treatment outcomes compared to patients with cancer lesions that are visible on MRI.
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INTRODUCTION: Approximately one million prostate biopsies are performed annually in the USA, and most are performed using a transrectal approach under local anaesthesia. The risk of postbiopsy infection is increasing due to increasing antibiotic resistance of rectal flora. Single-centre studies suggest that a clean, percutaneous transperineal approach to prostate biopsy may have a lower risk of infection. To date, there is no high-level evidence comparing transperineal versus transrectal prostate biopsy. We hypothesise that transperineal versus transrectal prostate biopsy under local anaesthesia has a significantly lower risk of infection, similar pain/discomfort levels and comparable detection of non-low-grade prostate cancer. METHODS AND ANALYSIS: We will perform a multicentre, prospective randomised clinical trial to compare transperineal versus transrectal prostate biopsy for elevated prostate-specific antigen in the first biopsy, prior negative biopsy and active surveillance biopsy setting. Prostate MRI will be performed prior to biopsy, and targeted biopsy will be conducted for suspicious MRI lesions in addition to systematic biopsy (12 cores). Approximately 1700 men will be recruited and randomised in a 1:1 ratio to transperineal versus transrectal biopsy. A streamlined design to collect data and to determine trial eligibility along with the two-stage consent process will be used to facilitate subject recruitment and retention. The primary outcome is postbiopsy infection, and secondary outcomes include other adverse events (bleeding, urinary retention), pain/discomfort/anxiety and critically, detection of non-low-grade (grade group ≥2) prostate cancer. ETHICS AND DISSEMINATION: The Institutional Review Board of the Biomedical Research Alliance of New York approved the research protocol (protocol number #18-02-365, approved 20 April 2020). The results of the trial will be presented at scientific conferences and published in peer-reviewed medical journals. TRIAL REGISTRATION NUMBER: NCT04815876.