Video

Recent Advancements in PI-RADS: mpMRI vs. bpMRI

Jelle Barentsz, MD, PhD, Professor of Radiology at the Nijmegen Medical Center of Radboud University in Nijmegen, The Netherlands, begins his talk on recent advancements in the prostate imaging-reporting and data system (PI-RADS) by asserting the value of local magnetic resonance imaging (MRI) in the diagnosis of prostate cancer. He cites the 2019 European Association of Urology (EAU) guidelines, which recommend performing a prostate MRI before biopsy, and points out that this results in 2,000,000 MRIs annually. He asserts there is a need for fast MRI, citing a PI-RADS committee position on MRI without the use of gadolinium (Gd)-based contrast medium (biparametric MRI, or bpMRI) which suggests that if certain prerequisites are satisfied, bpMRI may offer a fast MRI option for some patients. Dr. Barentsz then cites three studies. The first compared screenings using multi-parametric MRI (mpMRI) with bpMRI and found the prostate cancer detection rate was identical (but it failed to specify which patients had insignificant vs. clinically-significant prostate cancer [csPCa]). The second study compared single-plane (or “fast”) bpMRI vs. mpMRI and concluded mpMRI found nine percent more csPCa; however Dr. Barentsz points out the study was underpowered and used an older technique, a 1.5T endorectal coil (ERC) MRI. Dr. Barentsz explores data from the third study, which found that mpMRI and fast bpMRI demonstrated equal sensitivity in finding csPCa, at 95 percent. He outlines the pros and cons of the fast bpMRI, emphasizing that for less-experienced radiologists, the procedure increases uncertainty. Dr. Barentsz explains that the PI-RADS committee concludes there is a need to have both unenhanced MRI and contrast-enhanced MRI approaches available for prostate-cancer diagnosis. Dr. Barentsz then turns to the issue of costs, showing data comparing the direct cost of mpMRI, bpMRI, and “fast” bpMRI, specifying that mpMRI is more than twice as costly as “fast” bpMRI. Dr. Barentsz asserts that dynamic contrast-enhanced (DCE)-MRI is a better choice for patients with a previous negative bpMRI with persistent clinical suspicion, DWI-artifacts (e.g., hip prosthesis), and for doctors with a lower level of expertise. Dr. Barentsz then explains situations when bpMRI (no DCE) may be an appropriate choice, such as in a low-risk (screening) population or when there is a high chance of having significant prostate cancer. Dr. Barentsz concludes his talk by stating that bpMRI can be effective for very skilled prostate radiologists. He reiterates that DCE helps find small tumors, reduces uncertainty, and increases confidence. He also states that the prerequisites for bpMRI are good quality imaging, and specifies the need for objective quality assessment and control as well as training and certification.

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MRI-Guided Focal Therapy: Initial Quality-of-Life and Oncologic Outcomes

James A. Eastham, MD, FACS, Peter T. Scardino Chair in Oncology and Chief of the Urology Service in the Department of Surgery at Memorial Sloan-Kettering Cancer Center in New York, discusses initial results from a clinical trial examining safety, quality-of-life outcomes, and oncological outcomes of MRI-targeted focal therapy for patients with intermediate-risk prostate cancer. He explains that the goal with magnetic resonance (MR)-guided focused ultrasound (MRgFUS) therapy is to try to treat as little of the prostate gland as possible and that the difficulty lies in accurately targeting the area of the prostate to be destroyed. Dr. Eastham cites the limitations of MRI and asserts the importance of finding better ways to target areas for treatment. He then explains the clinical trial methodology and its primary endpoints, which focus on the safety of the procedure, as well as its examination of quality-of-life and oncologic outcomes. Dr. Eastham describes characteristics of the patient cohort and reviews initial results indicating the procedure is safe, with no serious adverse events observed among the 101 participants. According to six-month post-procedure biopsy results, 91 percent of men had no evidence of prostate cancer in the treatment area. Comparatively, however, six-month post-procedure biopsies of the whole gland showed the procedure does not adequately target the lesions or the areas with more significant cancers; the percentage of men with no evidence of GG≥2 prostate cancer anywhere in the prostate gland dropped to 78 percent. Dr. Eastham explains that this is a failure to appropriately identify all significant lesions, despite the fact that study participants underwent two separate biopsies. While few patients have yet undergone 24-month biopsies, of those who have, only 7.3 percent had GG≥2 detected in the treatment area. Additional results show decreased PSA levels after treatment that stabilized after six months. Dr. Eastham then presents data showing that with focal ablation, men do experience some decline in erectile function. He explains that this is one reason why low-risk patients may be better suited to active surveillance. However, study participants generally did not experience a decline in urinary function. Dr. Eastham concludes by reiterating that 24-month data is forthcoming. He explains that short-term data show this is a safe, well-tolerated procedure that may enable patients to consider a tissue-preserving approach and defer or avoid radical therapy. Looking to the future and phase 3 trials, Dr. Eastham explains that a meaningful endpoint will be a delay in disease progression as well as the consequent radical prostatectomy or radiation therapy.

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Integrating Theranostics Into a Group Practice

David M. Albala, MD, Chief of Urology at Crouse Hospital in Syracuse, New York, discusses theranostics and the role it will play in the future of prostate cancer treatment. He explains that theranostics is a management strategy involving the integration of therapeutics and diagnostics that specifically uses targeting molecules labeled with either diagnostic radionuclides or with therapeutic radionuclides for diagnosis of and therapy for a particular malignancy. Dr. Albala states that theranostics works to overcome trial and error methods of finding “one-size-fits-all” solutions in medicine in order to produce personalized medicine. Dr. Albala also discusses PSA and PSMA, explaining that PSMA is used with different ligands such as PSMA-11 and PSMA-617 to treat specific individuals. He reviews how theranostics are used with radionuclide agents to determine localization, examine molecular biodistribution, aid in determining optimal therapeutic dosage, and monitor the patient’s response to treatment. Dr. Albala then reviews data from a trial of Lutetium-177 and PSMA-617 for metastatic castration-resistant prostate cancer that showed Lutetium-based treatment outdoing standard-of-care in median overall survival by 4 months and skeletal event occurrence by 3%. He concludes with a summary of the implications of theranostics for patient care, stating that theranostics leads to more effective disease management and eliminates unnecessary treatments, enhances diagnosis and disease staging, and reduces costs associated with suboptimal diagnostics and treatments.

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No More Surprises: An Overview of the No Surprises Act

Grand Rounds in Urology Contributing Editor Neil H. Baum, MD, Professor of Urology at Tulane Medical School, summarizes the rules and implications of the No Surprises Act against unexpected out-of-network medical bills. He defines a surprise medical bill as one where a patient receives an often large bill for the difference between the out-of-network provider’s fee and the amount covered by the patient’s health insurance, and he notes that 2 out of 3 American adults are worried about these bills. Dr. Baum explains that the No Surprises Act, which was signed into law by Congress on December 27, 2020, prohibits out-of-network providers from billing patients more than in-network amounts, and that a violation brings a $10,000 fee per occurrence. He says that this most impacts out-of-network providers, emergency room physicians, and providers that a patient typically does not select, including hospitalists, radiologists, anesthesiologists, and pathologists. Dr. Baum then discusses the process that occurs if a provider disagrees with a payment, noting that the losing party of an Independent Dispute Resolution (IDR) must ultimately pay the cost of the IDR.

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Treatment for Prostate Cancer with MRI-Guided Transurethral Ultrasound

Laurence Klotz, MD, Professor of Surgery at the University of Toronto and the Sunnybrook Chair of Prostate Cancer Research, discusses MRI-guided transurethral ultrasound ablation (TULSA) in patients with localized prostate cancer. He characterizes this energy-based therapy as one that meets a need for patients with intermediate-risk prostate cancer, offering a less-invasive therapy with fewer quality-of-life effects than radiation and radical prostatectomy. Dr. Klotz explains the closed-loop controlled system and lays out the TULSA-PRO system components, emphasizing the power of the real-time thermal map when using thermal energy to heat tissue to destroy it. He then outlines the MRI-guided treatment workflow before listing the key features of TULSA: since it is a transurethral directional ultrasound ablation, it is incision- and radiation-free, with no energy being delivered through the rectum (thus avoiding rectal injury) and no volume limitation; the automated, closed-loop system eliminates guesswork and allows for precision, measuring temperature in real time, adjusting the amount of energy delivered to the tissue, and actively compensating for tissue and blood flow changes during the treatment; the therapy also offers thermal protection of important anatomy, including the urethra and rectum. Dr. Klotz then reviews previous TULSA technical and canine studies and the first-in-man treat and resect study for feasibility. This research led to a phase one safety and precision study that showed a 90 percent prostate-specific antigen (PSA) reduction. Dr. Klotz then reviews the TULSA-PRO Ablation Clinical Trial (TACT), which demonstrated a median PSA reduction of 95 percent, with consistent rates of biopsy-based improvement in 75-80% of men one year after TULSA therapy; data also show that TULSA therapy is easily tolerated and that most patients recover continence and erectile function within the year after therapy. Indeed, three-year follow-up data for TACT demonstrate that PSA response has been durable over time. Dr. Klotz concludes with a summary of TULSA, emphasizing the newness of this complex technology that is safe, precise, and has low toxicity. He highlights that it has been approved by the FDA and Health Canada and is emerging as a novel alternative to conventional therapy.

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