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Maha Hussain, MD, the Genevieve E. Teuton Professor of Medicine in the Division of Hematology and Oncology, was a co-author and steering committee member of the study published in The New England Journal of Medicine (NEJM).

A new drug, administered in combination with standard androgen-deprivation therapy and docetaxel chemotherapy, increased survival in patients with metastatic hormone-sensitive prostate cancer, according to a trial published in The New England Journal of Medicine (NEJM).

This represents a new strategy for managing metastatic hormone-sensitive prostate cancer (mHSPC), according to Maha Hussain, MD, the Genevieve E. Teuton Professor of Medicine in the Division of Hematology and Oncology, a co-author of the study and study steering committee member.

“This is a combination therapy in the first-line for patients with metastatic prostate cancer,” said Hussain, who is also deputy director of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University.

This trial was presented at the 2022 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium, held in San Francisco, Calif., and simultaneously published in NEJM.

Prostate cancer is the most common cancer and the second-leading cause of cancer mortality among men in the United States. Androgen deprivation therapy (ADT), which reduces levels of androgen hormones upon which prostate cancer relies, has been the mainstay of care for more than 60 years.

Most metastatic prostate cancers will eventually develop resistance to ADT, necessitating other therapeutic approaches — which have advanced considerably during the last 20 years. However, despite several life prolonging therapies, mHSPC continues to be a deadly disease, according to Hussain.

In the current double-blind, phase 3, multi-site trial, investigators enrolled patients with mHSPC, randomizing them to receive either darolutamide with standard ADT and docetaxel chemotherapy or a placebo with standard ADT and docetaxel chemotherapy. Darolutamide is a highly potent androgen receptor inhibitor, combining with the androgen reduction from ADT to more effectively starve the tumor of hormones it needs to survive.

“Darolutamide essentially closes the window in the cell, preventing any circulating testosterone from entering the cell,” Hussain said.

During the three-year trial period, patients receiving darolutamide were 32.5 percent less likely to die compared to patients receiving the placebo. In addition, patients receiving darolutamide experienced significantly delayed time to developing castration-resistant prostate cancer — the terminal state of the disease — and pain progression, helping reduce negative quality-of-life impacts.

Importantly, adverse events were not significantly different between the two study groups, indicating that darolutamide is a safe and effective therapy for patients with mHSCP. However, the findings are just one piece of a larger effort to impact the disease and reduce mortality, Hussain said.

“This is a very important and practice changing finding, but there is more to be achieved,” Hussain said. “Research and clinical trials are a very important step towards addressing scientific gaps and achieving a cure.”

This study was supported by Bayer and Orion Pharma.

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