Faculty Bibliography

CONTEXT/BACKGROUND:Whole-gland ablation is a feasible and effective minimally invasive treatment for localized prostate cancer (PCa). Previous systematic reviews supported evidence for favorable functional outcomes, but oncological outcomes were inconclusive owing to limited follow-up. OBJECTIVE:To evaluate the real-world data on the mid- to long-term oncological and functional outcomes of whole-gland cryoablation and high-intensity focused ultrasound (HIFU) in patients with clinically localized PCa, and to provide expert recommendations and commentary on these findings. EVIDENCE ACQUISITION/METHODS:We performed a systematic review of PubMed, Embase, and Cochrane Library publications through February 2022 according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement. As endpoints, baseline clinical characteristics, and oncological and functional outcomes were assessed. To estimate the pooled prevalence of oncological, functional, and toxicity outcomes, and to quantify and explain the heterogeneity, random-effect meta-analyses and meta-regression analyses were performed. EVIDENCE SYNTHESIS/RESULTS:Twenty-nine studies were identified, including 14 on cryoablation and 15 on HIFU with a median follow-up of 72 mo. Most of the studies were retrospective (n = 23), with IDEAL (idea, development, exploration, assessment, and long-term study) stage 2b (n = 20) being most common. Biochemical recurrence-free survival, cancer-specific survival, overall survival, recurrence-free survival, and metastasis-free survival rates at 10 yr were 58%, 96%, 63%, 71-79%, and 84%, respectively. Erectile function was preserved in 37% of cases, and overall pad-free continence was achieved in 96% of cases, with a 1-yr rate of 97.4-98.8%. The rates of stricture, urinary retention, urinary tract infection, rectourethral fistula, and sepsis were observed to be 11%, 9.5%, 8%, 0.7%, and 0.8%, respectively. CONCLUSIONS:The mid- to long-term real-world data, and the safety profiles of cryoablation and HIFU are sound to support and be offered as primary treatment for appropriate patients with localized PCa. When compared with other existing treatment modalities for PCa, these ablative therapies provide nearly equivalent intermediate- to long-term oncological and toxicity outcomes, as well as excellent pad-free continence rates in the primary setting. This real-world clinical evidence provides long-term oncological and functional outcomes that enhance shared decision-making when balancing risks and expected outcomes that reflect patient preferences and values. PATIENT SUMMARY/RESULTS:Cryoablation and high-intensity focused ultrasound are minimally invasive treatments available to selectively treat localized prostate cancer, considering their nearly comparable intermediate- to long term cancer control and preservation of urinary continence to other radical treatments in the primary setting. However, a well-informed decision should be made based on one's values and preferences.

BACKGROUND:The accumulation of data through a prospective, multi-center coordinated registry network (CRN) is a practical way to gather real world evidence on the performance of novel prostate ablation technologies. Urologic oncologists, targeted biopsy experts, industry representatives, and the Food and Drug Administration (FDA) convened to discuss the role, feasibility, and important data elements of a CRN to assess new and existing prostate ablation technologies. METHODS:A multi-round Delphi consensus approach was performed which included the opinion of 15 expert urologists, representatives of the FDA and leadership from HIFU device manufacturers. Stakeholders provided input in three consecutive rounds, with conference calls following each round to obtain consensus on remaining items. Participants agreed that these elements initially developed for HIFU are compatible with other prostate ablation technologies. CRN elements were reviewed and supplemented with data elements from FDA's common study metrics. RESULTS:The working group reached consensus on capturing specific patient demographics, treatment details, oncologic outcomes, functional outcomes, and complications. Validated health-related quality of life questionnaires were selected to capture patient-reported outcomes, which include IIEF-5, IPSS, EPIC-26, and MSHQ-EjD. Group consensus was to obtain a follow up multi-parametric MRI and prostate biopsy at approximately 12 months after ablation, with additional imaging or biopsy performed as clinically indicated. CONCLUSIONS:A national prostate ablation CRN brings forth vital practice pattern and outcomes data for this emerging treatment paradigm in the United States. Our multi-stakeholder consensus identifies critical elements to evaluate new and existing energy modalities and devices.

High Intensity Focused Ultrasound (HIFU) is a minimally invasive technology that produces thermal ablation of soft tissues. HIFU has been employed to treat prostate cancer and transrectal prostate HIFU devices have been in use worldwide since the mid 1990s. Prostate HIFU is not FDA approved in the United States; however, two manufacturers have HIFU devices currently under evaluation in the United States by the FDA. Prostate HIFU has been used to treat primary and radiation recurrent prostate cancer. In this presentation, the Sonablate (Sonacare Medical) and Ablatherm (EDAP) prostate HIFU devices will be compared. Published clinical outcomes for primary and salvage total and partial gland HIFU ablation will be presented. Long term studies document good clinical efficacy with biochemical recurrence, overall survival, and metastasis free survival similar to standard prostate cancer treatments. The advantages of HIFU ablation are similar to other ablation technologies: HIFU is an outpatient, minimally invasive treatment with low rates of ED and incontinence and can be repeated if there is local recurrence. Focal treatment with HIFU is a promising treatment strategy and the use of advanced MRI imaging to diagnose prostate cancer and to direct HIFU ablation will be presented. High patient demand for minimally invasive prostate cancer ablative treatments will inspire urologists interested in thermal ablation to obtain training and achieve competence in prostate HIFU therapy

OBJECTIVE: The purpose of this article is to review the roles that MRI is expected to play in emerging minimally invasive focal ablative therapies for prostate cancer. CONCLUSION: MRI, in combination with biopsy, will impact patient selection for focal ablation by helping to localize clinically significant tumor foci. Also, some ablation procedures may be performed using real-time MRI guidance. In addition, MRI may be used for assessment of extent of necrosis shortly after therapy and for long-term surveillance for recurrent tumor

The Medicare reimbursement rules have changed, and urologists must be prepared to change as well. They must take an active role in the management of their office practices, for the alternative will almost certainly have a negative impact on access for many patients, including those with prostate cancer. Urologists need to critically evaluate the daily operation of their practice, with an eye toward eliminating excess and increasing efficiency. This article discusses areas, such as staffing, collections, coding, and ancillary services, which can be optimized to meet the requirements of a successful urology practice in this changing environment