Erleada May Be a New Standard of Care for Some With Prostate Cancer

Recent real-world data suggest that Erleada (apalutamide) may offer an advantage over other treatment options for patients with metastatic castration-sensitive prostate cancer, according to Dr. Mehmet Bilen, a board-certified medical oncologist and lead study of peer-reviewed research comparing overall survival between patients treated with Erleada and Xtandi (enzalutamide), another key option for this patient population.

“The 23% reduction in mortality observed with Erleada in this real-world study may contribute to more informed treatment discussions between patients and their care teams… This type of real-world evidence can offer complementary insight into how treatments perform in routine practice settings,” Bilen emphasized in the interview.

To delve deeper into his research, and this topic, Bilen sat down for an interview with CURE, in which he discussed what patients with metastatic castration-sensitive prostate cancer should know about real-world data with Erleada and Xtandi. He also went on to explain the differences in treatment options, as well as highlighted the different side effect profiles of each agent.

Bilen is an associate professor in the Department of Hematology and Medical Oncology at Emory University School of Medicine, as well as the director of the Genitourinary Medical Oncology Program at Winship Cancer Institute of Emory University. Additionally, he works with the Fellowship Program of the Department of Hematology and Medical Oncology and serves on the Winship Clinical and Translational Review Committee.

CURE: What should patients with metastatic castration-sensitive prostate cancer take away from these recent real-world studies comparing Erleada (apalutamide) and Xtandi (enzalutamide)?

Bilen: As referenced in our published, peer-reviewed study in “Advances in Therapy”, patients should understand that Erleada and Xtandi are both approved and guideline-endorsed treatments for metastatic castration-sensitive prostate cancer; [however], recent real-world data suggest a potential survival advantage with Erleada. These findings reflect outcomes in diverse, routine clinical settings and can help inform treatment decisions beyond what is known from clinical trials.

It is important to note that real-world data are observational in nature, and these results will need to be validated in additional cohorts with longer-term follow-up before changing broad clinical practice. Still, this is an important step in understanding how different therapies perform in real-life populations.

The data showed a 23% reduction in mortality at 24 months with Erleada. How might this influence treatment discussions between patients and their care teams?

The 23% reduction in mortality observed with Erleada in this real-world study may contribute to more informed treatment discussions between patients and their care teams. While all androgen receptor pathway inhibitors (ARPIs) are approved and guideline-supported for metastatic castration-sensitive prostate cancer, head-to-head comparisons are lacking. This type of real-world evidence can offer complementary insight into how treatments perform in routine practice settings.

Discussions around ARPI selection should remain patient-centered, considering factors such as comorbidities, drug interactions, tolerability, and patient preferences. This study provides additional perspective that may help guide those conversations, particularly when evaluating first-line options.

How do real-world findings like these differ from clinical trial results, and why is it important for patients to understand the distinction?

Clinical trials are conducted in controlled environments with highly selected patient populations and predefined protocols, which are essential for establishing efficacy and safety. However, they may not fully represent the diversity and complexity of patients seen in everyday oncology practice.

It's important for patients and providers to understand that real-world data can offer valuable insights, especially in the absence of head-to-head trials. That said, with expanded use of electronic medical records and advances in artificial intelligence, the scope and reliability of real-world data are growing. These tools allow for more detailed, scalable, and timely analyses, which can enhance our ability to personalize treatment and understand outcomes across diverse settings. As a result, real-world evidence is increasingly complementing clinical trials to inform treatment decisions in a more practice-relevant way.

For patients already on Xtandi or Zytiga (abiraterone acetate), should these findings prompt conversations with their oncologist about switching therapies?

The findings highlight potential differences in outcomes but are not a call for widespread switching, especially in patients doing well on their current regimen. However, they may prompt thoughtful discussions in specific scenarios, such as early progression, tolerability issues, or when re-evaluating long-term treatment strategy.

Can you explain how side effects and quality-of-life considerations factor into the choice between Erleada, Xtandi and Zytiga?

Side effect profiles differ across ARPIs and should be considered alongside efficacy. Abiraterone requires daily steroids and frequent lab monitoring. Xtandi may have more central nervous system-related side effects such as fatigue or cognitive changes. Erleada can cause rash but is generally manageable. Balancing these considerations with patient comorbidities, lifestyle, and preferences is essential.

What advice would you give patients who are newly diagnosed with metastatic castration-sensitive prostate cancer and are overwhelmed by the number of available treatment options?

It’s completely understandable to feel overwhelmed at the time of diagnosis, especially with the growing number of effective therapies now available. My advice is to engage in open, honest discussions with your care team; ask questions, express concerns, and make sure you understand the goals and trade-offs of each option. Shared decision-making ensures the treatment plan reflects both the clinical evidence and the patient’s values.

That said, I think it’s always better to have multiple choices rather than too few. The expansion of ARPI options and treatment combinations reflects real progress in the field. With the help of your oncologist, having several effective therapies to choose from allows for a more tailored approach based on individual health status, lifestyle, and preferences.

Looking ahead, how do you see real-world evidence shaping future prostate cancer care, especially in personalizing treatment for diverse patient populations?

Real-world evidence will play an increasingly important role in tailoring prostate cancer care. It allows us to evaluate how therapies perform outside of clinical trials, particularly in historically underrepresented populations. As data sources grow more sophisticated, incorporating genomics, comorbidities, and social determinants of health, real-world insights will be key to delivering more equitable and personalized cancer care.

Transcript has been edited for clarity and conciseness.

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