Erleada Shows Survival Advantage in Real-World Study of Metastatic Prostate Cancer

New real-world evidence suggests that treatment choice may make a meaningful difference for patients living with metastatic castration-sensitive prostate cancer (mCSPC), according to a news release from Johnson & Johnson. A large head-to-head analysis found that patients who started treatment with Erleada (apalutamide), without chemotherapy, experienced a significantly lower risk of death compared with those who received Nubeqa (darolutamide) without docetaxel.

According to findings, which were also presented at the 36th Annual International Prostate Cancer Update, patients treated with Erleada had a 51% reduction in the risk of death through 24 months of follow-up compared with patients treated with Nubeqa. Researchers reported a hazard ratio of 0.49, meaning patients receiving Erleada were roughly half as likely to die during the study period. The results were statistically significant.

Importantly, this is the first real-world, head-to-head comparison of overall survival between Erleada and Nubeqa in patients with mCSPC, offering new insight into how these therapies perform outside of clinical trials.

"These real-world data show the survival benefit of apalutamide versus darolutamide in patients with mCSPC without the concurrent use of docetaxel. The results are consistent with other datasets showing similar overall survival benefit versus other commonly used agents," said Dr. Mehmet Bilen, director of Genitourinary Medical Oncology Program, Winship Cancer Institute of Emory University, in the news release. "This real-world analysis utilized large contemporary datasets using rigorous methodology to support clinical decision-making in the absence of prospective head-to-head studies that are likely impractical to conduct."

Real-world study shows improved overall survival with Erleada

The retrospective analysis evaluated outcomes for patients treated in routine U.S. clinical practice rather than in controlled trial settings. Investigators identified 1,460 patients who initiated Erleada and 287 patients who initiated Nubeqa, all without docetaxel chemotherapy, between August 2022 and June 2025.

After adjusting for differences in patient characteristics, researchers found that patients receiving Erleada lived longer overall. At 24 months, 92.1% of patients treated with Erleada were alive, a rate that compares favorably with survival outcomes previously reported in clinical trials.

Building on prior evidence from the TITAN trial

The new real-world data build on earlier evidence supporting Erleada in metastatic castration-sensitive prostate cancer. In the phase 3 TITAN trial, more than 1,000 patients were randomly assigned to receive Erleada plus androgen deprivation therapy (ADT) or ADT alone.

In that study, Erleada significantly improved overall survival at both the initial and final analyses. Patients receiving Erleada plus ADT had a 35% reduction in the risk of death at the final analysis compared with ADT alone. The trial also showed benefits in radiographic progression-free survival, meaning cancer spread was delayed.

Additionally, earlier analyses demonstrated that Erleada was associated with rapid and deep declines in prostate-specific antigen (PSA) levels, a marker often used to track prostate cancer activity. These PSA responses were linked with longer survival, reinforcing the clinical relevance of the treatment.

The current real-world findings suggest that the survival benefits seen in controlled trials may extend to patients treated in typical oncology practices.

How researchers compared treatments fairly

Because this was not a randomized clinical trial, investigators used statistical techniques to help ensure a fair comparison between treatment groups. Specifically, they applied inverse probability of treatment weighting, a form of propensity score matching that balances baseline characteristics such as age, disease features and prior treatments.

This approach is designed to mimic the conditions of a randomized study and reduce bias from measured confounding factors. Researchers also performed power calculations in advance to ensure the study included enough patients to detect meaningful differences in survival.

The study focused on patients diagnosed with metastatic castration-sensitive prostate cancer, meaning their disease had spread beyond the prostate but still responded to hormone therapy. All patients were treated with either Erleada or Nubeqa without docetaxel chemotherapy, allowing for a clearer comparison of the two androgen receptor inhibitors.

Patients reflected a contemporary, real-world population treated across U.S. clinical settings. This diversity helps capture how therapies perform among patients who may not meet strict clinical trial eligibility criteria, including those with varying health backgrounds and comorbidities.

Additional findings and what this means for patients

Experts noted that real-world evidence complements randomized clinical trials by showing how treatments work in everyday practice. For patients and caregivers, these findings highlight the importance of early treatment decisions in advanced prostate cancer.

Prostate cancer remains a major public health issue, with approximately 330,000 new diagnoses each year in the United States. Despite advances in care, thousands of men continue to die from the disease annually, underscoring the need for effective therapies that improve survival.

Erleada is currently approved for both non-metastatic castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer. As with all cancer treatments, it carries potential side effects, including fatigue, rash, falls, fractures, cardiovascular events and rare but serious reactions. Patients are encouraged to discuss benefits and risks with their care team to determine whether Erleada is an appropriate option based on individual health factors.

Overall, this head-to-head real-world analysis provides new evidence that Erleada may offer a meaningful survival advantage over Nubeqa for patients with metastatic castration-sensitive prostate cancer treated without chemotherapy, helping inform shared decision-making between patients and their oncologists.

"Real-world comparisons can provide critical information to support patient care when conducted in a rigorous and methodologically sound manner," said Dr. Mahadi Baig, vice president of U.S. Medical Affairs at Johnson & Johnson Innovative Medicine, in the news release. "We have now seen in repeated real-world examinations the overall survival benefit of apalutamide versus other agents and this head-to-head analysis supports apalutamide being a key standard of care treatment for patients with mCSPC.”

References

1. Real-world head-to-head analysis shows 51% reduction in risk of death for patients with metastatic castration-sensitive prostate cancer treated with ERLEADA® (apalutamide) versus darolutamide without docetaxel through 24 months, by Johnson & Johnson. News release; Feb. 2, 2026.

Editor's note: This article is for informational purposes only and is not a substitute for professional medical advice, as your own experience will be unique. Use this article to guide discussions with your oncologist. Content was generated with AI and reviewed by a human editor.

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