Video

Implications of the FDA Approval of Combination Talazoparib & Enzalutamide Therapy

Dr. E. David Crawford and Dr. Neeraj Argawal, MD, FASCO, discuss the recent FDA approval of Enzalutamide combined with Talazoparib. In this discussion, they examine a Phase 3 trial comparing Enzalutamide and Talazoparib versus Enzalutamide alone on mCRPC patients.

The results of the trial yielded significant differences in the outcomes between the Enzalutamide and Talazoparib combination arm and the Enzalutamide-Only arm. 37% decrease in the risk of progression or death was observed in the combination arm of the trial. In patient populations with tumors containing HRR mutations, the risk of progression or death was decreased by 55%.

Following its recent FDA approval, Dr. Crawford and Dr. Argawal discuss the clinically appropriate populations for Enzalutamide and Talazoparib combination therapy, the process of diagnosis, and the limitations of the therapy. Dr. Argawal emphasizes the necessity of germline testing in identifying predispositions to mCRPC patients and their families.

Dr. Crawford and Dr. Argawal conclude by examining the time to PSA progression in the two trial arms. In the Enzalutamide-Only arm of the trial, average time to progression was 11 months, whereas time to progression in the Combination arm was 28 months. They recognize that the overall survival data is immature at this time, but recognize that short-term benefits of combination therapy for this patient population are significant across the board.

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Challenging Case Discussion Panel: Men’s Health

Martin M. Miner, MD, discusses a challenging case involving testosterone therapy, cardiovascular risk, and prostate cancer. He begins by providing information about a case study patient, highlighting obesity, low testosterone levels, and diminished libido. Dr. Miner then discusses data that find a connection between testosterone therapy and increased cardiovascular risk.

He notes a review of all articles from 1940 to 2014 researching this connection, finding only four studies indicating a connection and uncovering major flaws in their procedures. This leads him to question the link between testosterone therapy and increased cardiovascular risk while also describing the case study patient’s testosterone therapy treatment. Dr. Miner then reviews guidelines from the American Urological Association and the Endocrine Society. He references the case study patient once again, noting the patient’s development of cardiac events and questions whether the patient should return to testosterone therapy.

After reviewing additional data on this topic, Dr. Miner concludes that testosterone therapy has at least neutral effects on cardiovascular risk factors, although additional studies are needed. He transitions the discussion back to the case study patient, noting his new development of prostate cancer and reviewing data on testosterone therapy’s effects on prostate cancer. Dr. Miner opens the discussion up to panelists, who discuss testosterone levels, obesity management, and individualized urologic treatment.

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Identification of Localized Disease

Peter F. Orio III, DO, MS, discusses the process of identifying localized prostate cancer. Dr. Orio emphasizes that prostate cancer is a spectrum of disease, rather than a binary, as prostate cancer is not necessarily confined to the prostate organ alone, and that the ultimate goal of treatment is reduction of harm to the patient’s future self.

Dr. Orio reviews the current screening, imaging, and testing steps to identifying localized prostate cancer, including the best candidates for screening. He notes that mandatory DREs discourages patients from coming in to the urologist, and suggests that screening should eliminate them.

Dr. Orio offers the more sensitive and less invasive PSA tests in combination with MRIs as an alternative first step in screening. He concludes by offering PSA – MRI – Fusion Biopsy – Germline Testing – FHX – FNX Imaging as the new path for screening and identifying localized prostate cancer.

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Financial Toxicity: The New Driver of Healthcare Policy?

Deepak A. Kapoor, MD, FACS, discusses the issue of financial toxicity in healthcare, which he believes will shape health policy. He highlights the rising healthcare costs in the United States compared to other OECD countries, emphasizing the increasing burden shifted onto patients. This shift is primarily driven by the formation of healthcare exchanges, leading to higher deductibles, co-payments, and changing insurance plans.

Kapoor reveals that urological tumors account for a significant portion of cancer spending in the United States, exceeding $200 billion annually. Cancer care, in general, poses a profound economic burden, with patients depleting their savings, reducing retirement funds, and delaying medical care due to costs. Disturbingly, one in four cancer patients lose their homes within five years of diagnosis.

Dr. Kapoor emphasizes the disproportionate impact of this economic burden on marginalized populations, including single mothers, low-income individuals, and historically marginalized groups like Blacks and Hispanics. Dr. Kapoor provides an example of how a simple referral to a hospital-based imaging facility can result in significantly higher costs compared to a radiology facility in a community setting.

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Guidelines and Practical Applications: Artificial Urinary Sphincter

William O. Brant, MD, FACS, FECSM, reviews the 2018 American Urological Association (UAU) guidelines and practical approaches in erectile dysfunction (ED) evaluation, diagnosis, and treatment. He examines methods for evaluation and diagnosis, highlighting the psychological impacts of ED and ED’s connection to cardiovascular disease. Dr. Brant also explores specialized tests and multiple treatment options.

Dr. Brant examines other treatment modalities, such as the vacuum erection device, as a low-cost adjunct treatment. He discusses the intraurethral suppository treatment and warns that up to 30 percent of patients experience urethral pain with this option. Dr. Brant then explains the risks of injection options and surgery. He also analyzes the practicality and commitment inherent in penile prostheses, later transitioning to a discussion on the uncommonly performed arterial reconstruction option.

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