Dr. Katherine Virgo on the Updated Guideline for mCRPC

By Katherine Virgo, PhD, MBA - Last Updated: May 2, 2023

The American Society of Clinical Oncology recently released an updated guideline for the management of advanced or metastatic prostate cancer. It includes new treatment recommendations based on results from the ARASENS and PEACE-1 trials, among others.

GU Oncology Now met with Katherine Virgo, PhD, MBA, an adjunct professor at the Emory University Rollins School of Public Health, Department of Health Policy and Management, and a member of the Contributed Abstract Review Committee, Medical Care Section, for the American Public Health Association Annual Meeting, to discuss the updated guideline and how it will affect patients with prostate cancer moving forward.


What does this new focused guideline update entail?

Dr. Virgo: The major clinical findings pertain to the benefits of triplet therapy compared with doublet therapy for de novo metastatic noncastrate prostate cancer (NCPC). The results, which were practice-changing, were from the PEACE-1 and ARASENS trials.

The PEACE-1 trial found that a triplet therapy consisting of abiraterone and prednisone plus androgen deprivation therapy (ADT) and docetaxel demonstrated significant overall survival (OS) and radiographic progression-free survival benefits compared with a doublet therapy of ADT and docetaxel alone in patients with high-volume de novo metastatic NCPC. Overall, survival data for patients with low-volume de novo metastatic NCPC from the PEACE-1 trial were still too immature to justify recommending an abiraterone-based triplet therapy, abiraterone and prednisone plus ADT and docetaxel, for patients with low-volume de novo NCPC.

The ARASENS trial found that darolutamide plus ADT and docetaxel demonstrated significant OS benefits compared with placebo plus ADT and docetaxel in addition to significantly longer time to castration-resistant prostate cancer, pain progression for skeletal event, and initiation of subsequent systemic antineoplastic therapy.

Did the ENZAMET or ARCHES trials result in any new guideline updates?

Dr. Virgo: There was no change with respect to the 2021 recommendations for enzalutamide other than to report long-term results from the ENZAMET and ARCHES trials that were not available in 2021. ADT plus enzalutamide should be offered to patients with metastatic NCPC, including both those with de novo metastatic disease and those who have received prior therapies, such as radical prostatectomy or radiotherapy, for localized disease.

Are there any data that patients should know about ADT plus enzalutamide?

There’s nothing different to note in regard to side effects compared with the doublet therapies that they may already be receiving. The cost of these additional treatments is more of an issue; enzalutamide is not viewed as a cost-effective drug, unlike abiraterone.

Are there any other prostate cancer treatments that are currently being researched that may affect future guideline updates?

The biggest question currently is whether or not docetaxel is still necessary in the treatment of patients with metastatic NCPC. Currently, no phase 3 clinical trials have compared, for example, ADT plus darolutamide or ADT plus abiraterone versus ADT plus docetaxel. Also, improved OS for patients undergoing triplet therapy is largely confined to those with high-volume disease. For patients with low-volume disease, clinical trials have shown no significant benefit of triplet therapy, so this may change guidelines in the future.