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PEER-TO-PEER CLINICAL CONVERSATIONS |
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| Systematic Review Sheds Light on Treatment Intensification in Metastatic Prostate Cancer |
Peter Goebell, MD, PhD
Zach Klaassen and Peter Goebell discuss a systematic review focused on treatment intensification for metastatic hormone-sensitive prostate cancer. Dr. Goebell's study aims to assess if scientific evidence, as outlined in guidelines, translates into real-world practice changes. |
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IMPLEMENT Study: Addressing the Underutilization of Treatment Intensification in Metastatic Castration-Sensitive Prostate Cancer
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Stacy Loeb, MD, MSc, PhD (Hon)
Zach Klaassen and Stacy Loeb discuss the IMPLEMENT Study, which investigates the underutilization of treatment intensification in metastatic hormone-sensitive prostate cancer. Despite guidelines recommending this approach, it is used in less than a third of cases.
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ARANOTE - Darolutamide in Addition to ADT Vs. ADT in Metastatic Hormone-Sensitive Prostate Cancer
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Fred Saad, MD, FRCS
Alicia Morgans and Fred Saad discuss the ARANOTE trial, assessing darolutamide and androgen deprivation therapy, as compared to ADT alone in patients with metastatic hormone-sensitive prostate cancer. |
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| Bayer Announces Positive Topline Results for NUBEQA® (Darolutamide) from the Phase III Trial in Men with Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
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| PRESS RELEASE
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| The Phase III ARANOTE trial, investigating NUBEQA® (darolutamide) plus androgen deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC), has met its primary endpoint of radiological progression-free survival (rPFS). NUBEQA plus ADT demonstrated a statistically significant and clinically meaningful increase in rPFS compared to placebo plus ADT. Results were consistent with NUBEQA’s established safety profile with no new signals observed. Detailed results from this randomized, double-blind, placebo-controlled trial are planned to be presented at a forthcoming scientific congress.
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| Metastatic Castration-Sensitive Prostate Cancer: If Treatment Intensification Is the Standard, Who and How Can We Treatment Deintensify?
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| Evan Yu, MD
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| Metastatic castration-sensitive prostate cancer treatment benefits from intensification with ARPIs like abiraterone, enzalutamide, apalutamide, and docetaxel for high-volume disease. However, treatment de-intensification for patients with good prognosis or significant competing causes of mortality is being explored to improve quality of life. Ongoing trials like LIBERTAS and A-DREAM are investigating intermittent ADT and ARPI regimens, while efforts continue to identify better molecular prognostic markers for tailored treatment approaches.
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| A Randomized, Controlled, Phase 3 Study of Darolutamide in Addition to ADT Versus ADT Alone in Metastatic Hormone-Sensitive Prostate Cancer (ARANOTE) |
| Dayanand Sharma, MD, DNB |
| The ARANOTE trial is a phase 3, international, multicenter, randomized, double-blind, placebo-controlled study evaluating darolutamide plus androgen deprivation therapy (ADT) versus ADT alone in patients with metastatic hormone-sensitive prostate cancer (mHSPC). The primary endpoint is radiographic progression-free survival (rPFS), with secondary endpoints including overall survival, time to castration-resistant prostate cancer, and safety profiles. |
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| Clinical and Patient Factors Associated with Treatment Intensification for mHSPC
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| Sreevalsa Appukkuttan, MPH, MBBS
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| Sreevalsa Appukkuttan presented findings on factors influencing treatment intensification for mHSPC using data from OPTUM. Among 1,123 mHSPC patients who received ADT between 2020 and 2022, 57% received intensified therapy within 90 days, with the most common treatments being abiraterone acetate and enzalutamide. The study highlighted disparities in treatment by age, region, and metastasis site, suggesting the need for further research to address under treatment.
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| Differences in Barriers and Facilitators to First-Line Treatment Intensification in Metastatic Castration-Sensitive Prostate Cancer Between Urologists and Oncologists: A Sub-Analysis of the IMPLEMENT Study |
| Stacy Loeb, MD |
| Stacy Loeb presented a sub-analysis of the IMPLEMENT study, which explored differences in barriers and facilitators to first-line treatment intensification for metastatic castration-sensitive prostate cancer (mCSPC) between urologists and oncologists. The study found that treatment intensification remains underutilized, with only 13% of urologists and 37% of oncologists implementing such therapy. Key barriers included knowledge gaps and the tendency to wait for second-line treatment or severe disease. |
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| Interaction of Age and Benefit of Treatment Intensification in Advanced Prostate Cancer: An Aggregate Meta-Analysis of 14 Randomized Trials |
| Alicia Morgans, MD, MPH |
| Alicia Morgans presented an aggregate meta-analysis of 14 randomized trials examining the interaction between age and the benefit of treatment intensification in advanced prostate cancer. The study found that while treatment intensification significantly improves overall survival in advanced prostate cancer, younger men benefit more than older men. Specifically, older men showed minimal survival benefit from abiraterone and/or docetaxel, but significant benefit from non-abiraterone androgen receptor-signaling inhibitors. |
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