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Urology News and Education Resource
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Monday, 13 May 2024 |
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Hormone Sensitive Metastatic Disease. The Glass is 25-33% Empty.
Charles Ryan, MD
What if we knew Rb status in the newly diagnosed metastasis, and what if we knew that when the disease progressed, it was progressing with an intact Rb versus a lost Rb? What if we could develop a therapy that could prevent Rb loss? Charles Ryan shares details on a new study called CASCARA, where the efficacy and tolerability of ADT plus Cabazitaxel and Carboplatin followed by Abiraterone in patients with high volume castration sensitive disease are being evaluated in an effort to start thinking differently about metastatic hormone sensitive disease.
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Blink and You’ll Miss Something - Incorporating the Advances in Treatment of mHSPC into Clinical Practice
Alicia Morgans, MD, MPH
Many questions remain in the treatment of mHSPC. Each advance adds knowledge, but also areas of uncertainty. As the field continues the search for a cure, advances in mHSPC will certainly be a part of that journey. The definition of mHSPC includes a variety of men, from those with oligometastatic disease, to low volume, to high risk, to men with so much high volume metastatic disease that they have super scans and visceral disease. The disease in these patients is driven by different biology that is as of yet minimally characterized. If you blink, you will miss the rapid accumulation of advances as they roll in. Blink twice, and you’ll miss the many questions that each forward step brings, too.
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Darolutamide Demonstrates Efficacy and Safety in Men with nmCRPC
Neeraj Agarwal, MD
Petros Grivas interviews with Neeraj Agarwal on insights about the latest prostate cancer study results that will impact patient care as presented at ASCO GU 2019.The ARAMIS trial. Evaluating the efficacy of darolutamide for delaying metastasis and death in men with nonmetastatic, castration-resistant prostate cancer.
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ARAMIS Trial in Prostate Cancer: Impact of Darolutamide on Pain and Quality of Life.
Karim Fizazi, MD, Ph.D
Follow-up discussion on the quality of life parameters evaluated in the ARAMIS trial. Darolutamide was also associated with benefits with regard to all secondary endpoints, including overall survival, time to pain progression, time to cytotoxic chemotherapy, and time to a symptomatic skeletal-related event.
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ENZAMET: Overall Survival Results of a Phase III Randomized Trial of Standard-of-care Therapy with or without Enzalutamide for mHSPC, an ANZUP-led International Cooperative Group Trial.
ENZAMET is the first mHSPC trial to report OS data of enzalutamide + testosterone suppression and outcomes if patients also received concurrent docetaxel. The ENZAMET hypothesis is that enzalutamide added to testosterone suppression with greater inhibition of the androgen receptor will (i) prolong OS, (ii) be first-line therapy for mHSPC (iii) with or without concurrent docetaxel, and will do so (iv) more than the addition of a standard non-steroidal anti-androgen (bicalutamide, nilutamide, or flutamide) – the first study to include as an active control.
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ARAMIS: Efficacy and Safety of Darolutamide in Nonmetastatic Castration-Resistant Prostate Cancer.
Karim Fizazi, MD and colleagues present the efficacy and safety data of ARAMIS study. This was a double-blind, placebo-controlled phase III trial randomized controlled trial in which nmCRPC patients were randomized in a 2:1 ratio to receive either darolutamide 600 mg twice-daily or placebo, while continuing ADT. Patients were stratified by PSA doubling time and use of osteoclast-targeted therapy, similar to PROSPER and SPARTAN studies.
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Discussion on: The ARAMIS Trial, the Final Analysis of LATITUDE Study, and the ARCHES Trial
LATITUDE (final results), ARAMIS, and ARCHES. With regards to the following question to determine if it should change clinical practice: 1) Is the condition one that requires treatment? 2) Is there a meaningful endpoint? 3) Does the agent have acceptable toxicity? 4) Does it compromise the efficacy of subsequent therapies? 5) Ideally, it must also be cost-effective.
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Darolutamide Elicits a Strong PSA Response in Men with nmCRPC: Results from the ARAMIS Study.
Non-metastatic (M0) CRPC (nmCRPC) is defined as a rising PSA in the setting of non-metastatic disease in the castrate state. The primary goal of treatment for these patients is the delay of metastases, considering that morbidity and mortality are both significantly worse following progression to metastases. Agents, such as darolutamide, are being developed to target the androgen axis.
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Final Analysis of LATITUDE, A Phase III in Patients with Newly Diagnosed High-risk Metastatic Castration-naïve Prostate Cancer.
The LATITUDE study, phase III randomized, clinical trial that evaluated the efficacy of abiraterone acetate and prednisone with ADT in men with newly-diagnosed, mCSPC. 1199 men were randomized to receive ADT with abiraterone and prednisone, versus ADT with dual placebos. Primary endpoints of this study were OS and radiographic PFS. This study showed that ADT+ abiraterone and prednisone conferred a survival benefit over ADT alone, but also showed that there was an improvement in PROs over the course of the trial.
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