Icahn School of Medicine at Mount Sinai

Optilume® BPH Catheter System Data from the PINNACLE Trial Published in the September 2023 Journal of Urology

Steven A. Kaplan, MD, joins E. David Crawford, MD, Editor-in-Chief of Grand Rounds in Urology, to discuss the results of the PINNACLE trial published in the September 2023 issue of the Journal of Urology. The PINNACLE trial was a Phase 3 study examining the effectiveness of treating benign prostate hyperplasia (BPH) with the Optilume® BPH Catheter System.

The Optilume® BPH Catheter System is a novel drug/device combination minimally invasive surgical therapy for the treatment of lower urinary tract symptoms secondary to BPH, and it has been recently approved by the FDA. Dr. Kaplan explains how the mechanical dilation with Optilume® BPH achieves an anterior commissurotomy separating the lateral lobes of the prostate, while delivery of paclitaxel is intended to maintain luminal patency during healing.

Over the course of the discussion, Drs. Kaplan and Crawford examine:

The history of devices used to treat BPH.
The design of the Optilume® BPH Catheter System and its effects on flow and proliferative rates.
The design of the PINNACLE trial.
The immediate and long-term results for patients treated with Optilume® BPH versus those of patients treated with the sham.
What the results may mean for the future of BPH treatment in office and ambulatory settings.
For more informational content on the latest developments on men’s health topics like BPH, please visit our Men’s Health Next-Generation Learning Center.

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New Standards of Care for Advanced Prostate Cancer

In this 20-minute presentation, William K. Oh, MD, Chief of the Division of Hematology and Medical Oncology at the Mount Sinai Health System and Deputy Director of The Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai, addresses new standards of care in 2021 for advanced prostate cancer and focuses on non-metastatic castration-resistant prostate cancer (nmCRPC), concluding that apalutamide, enzalutamide, and darolutamide improve MFS in men with nmCRPC by ~2 years; SPARTAN, PROSPER, and ARAMIS established favorable benefit-risk for patients with nmCRPC and PSADT<10 months; and these studies provide the best evidence supporting early treatment. He also focuses on metastatic, hormone-sensitive prostate cancer (mHSPC) and concludes that upfront treatment with either abiraterone + prednisone, apalutamide, enzalutamide, or docetaxel is the standard of care and he asserts that new evidence from PEACE-1 and ARASENS supports triple therapy with a novel hormonal therapy +ADT+docetaxel for chemotherapy patients.

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Transperineal Mapping Biopsy: Does Technique Matter?

Nelson N. Stone, MD, Professor of Urology, Radiation Oncology, and Oncological Sciences at the Icahn School of Medicine at Mount Sinai and at the Derald H. Ruttenberg Cancer Center at Mount Sinai School of Medicine in New York, discusses transperineal mapping biopsy (TPMB). He explains that treating a single quadrant as identified by MRI may leave unidentified clinically-significant prostate cancer behind. For focal therapy, Dr. Stone advocates for what he calls a unified approach using TPMB, which can be done under local anesthesia.

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