Alicia Morgans, MD, MPH

Panelists discuss how the recent FDA approval of darolutamide for metastatic hormone-sensitive prostate cancer (mHSPC) expands treatment options, offering improved tolerability with lower fatigue rates and fewer central nervous system adverse effects than other androgen pathway inhibitors, while exploring considerations for patient selection, trial design interpretation, and the evolving role of real-world evidence in clinical decision-making.

Panelists discuss how the recent FDA approval of darolutamide for metastatic hormone-sensitive prostate cancer (mHSPC) expands treatment options, offering improved tolerability with lower fatigue rates and fewer central nervous system adverse effects than other androgen pathway inhibitors, while exploring considerations for patient selection, trial design interpretation, and the evolving role of real-world evidence in clinical decision-making.

The experts discuss how recent therapeutic advances and trial data are reshaping standard care in advanced prostate cancer.

Alicia Morgans, MD, MPH, and Paul Sieber, MD, introduce the discussion, outlining goals to connect evolving mCRPC research with personalized immunotherapy practice.

Jack R. Andrews, MD; Alicia Morgans, MD, MPH; and Murilo de Almeida Luz, MD, discuss how ultralow prostate-specific antigen thresholds (below 0.02) serve as important prognostic biomarkers in metastatic hormone-sensitive prostate cancer, with recent post hoc analyses from the ARANOTE trial showing that patients achieving these ultralow levels with combination androgen deprivation therapy plus darolutamide therapy have significantly better radiographic progression-free survival and time to castration-resistant disease compared with those who don't reach these thresholds.

Jack R. Andrews, MD; Alicia Morgans, MD, MPH; and Murilo de Almeida Luz, MD, discuss how ultralow prostate-specific antigen thresholds (below 0.02) serve as important prognostic biomarkers in metastatic hormone-sensitive prostate cancer, with recent post hoc analyses from the ARANOTE trial showing that patients achieving these ultralow levels with combination androgen deprivation therapy plus darolutamide therapy have significantly better radiographic progression-free survival and time to castration-resistant disease compared with those who don't reach these thresholds.

Jack Andrews, MD; Alicia Morgans, MD, MPH; and Ashley Ross MD, PhD, discuss how trial design, inclusion criteria, and end points like radiographic progression-free survival vs overall survival impact clinical decision-making in prostate cancer treatment, emphasizing the importance of quality of life data and the shift from using ADT alone as standard care toward combination therapies in prostate cancer management.

Jack Andrews, MD; Alicia Morgans, MD, MPH; and Ashley Ross MD, PhD, discuss how trial design, inclusion criteria, and end points like radiographic progression-free survival vs overall survival impact clinical decision-making in prostate cancer treatment, emphasizing the importance of quality of life data and the shift from using ADT alone as standard care toward combination therapies in prostate cancer management.

The ARASTEP trial is exploring the combination of darolutamide plus ADT vs ADT alone in patients with high-risk biochemical recurrence of prostate cancer.

Alicia K. Morgans, MD, MPH, highlights quality of life data from the phase 3 ARANOTE trial.

"We need to be aware that patients have options for treatment of high-risk biochemical recurrence, and in order to identify that they have high-risk biochemical recurrence...we need to calculate PSA doubling time,” says Alicia Morgans, MD, MPH.

"It is important for us to ask patients whether they want to intensify or not, and not make assumptions," says Alicia Morgans, MD, MPH.

"I think that 1 of the main reasons physicians weren't necessarily acting is that they weren't getting a full picture of how aggressive the disease was," says Alicia Morgans, MD, MPH.

"I think the most important thing to improve our reporting of PSA doubling time is to remind clinicians why it's important to even calculate this number," says Alicia Morgans, MD, MPH.

"We found that actually, many, many physicians were not reporting PSA doubling time," says Alicia Morgans, MD, MPH.