Drs Antonarakis and Jha on Extending Clinical Trials to the Community Setting

Emmanuel Antonarakis, MD, associate director, Translational Research, Masonic Cancer Center, University of Minnesota, Clark Endowed Professor of Medicine, University of Minnesota Medical School; and Gautam Jha, MD, medical director, M Health Fairview Masonic Cancer Clinic and the Advanced Treatment Center at the M Health Fairview Clinics and Surgery Center—Minneapolis, chair, cancer committee, M Health Fairview Ridges Hospital, highlight the significance of collaboration to extend the reach of clinical trials beyond the confines of university hospitals, thus enhancing patient accessibility and engagement within the community setting.

In particular, Antonarakis and Jha discussed the collaborative effort used by the University of Minnesota and surrounding community cancer centers to drive enrollment to the phase 3 ECLIPSE trial (NCT05204927), which evaluated 177Lu-PSMA-I&T vs standard-of-care hormone therapy with abiraterone acetate (Zytiga) or enzalutamide (Xtandi) in patients with metastatic castration-resistant prostate cancer (mCRPC) who experienced progressive disease and received prior treatment with an androgen receptor–directed therapy.

By partnering with community oncologists affiliated with the University of Minnesota, the goal was to broaden the trial’s patient pool. Although 177Lu-PSMA-I&T, which is a radiopharmaceutical, required administration at the University of Minnesota due to safety protocols, patient identification and recruitment efforts were decentralized to community settings, Antonarakis says.

Jha underscores the practical benefits of this collaborative approach, particularly in alleviating the burden of travel for patients—a factor often impeding trial participation for those being treated in the community. Leveraging existing networks within the community, Jha explains that he and his team effectively engaged local oncologists to identify potential candidates for the trial.

Jha's commitment to supporting his colleagues in identifying eligible patients underscores the collaborative ethos driving this endeavor. This collaborative model demonstrates a pragmatic approach to trial recruitment, capitalizing on the strengths of both academic and community oncology settings.

By decentralizing patient identification and engagement efforts, the trial effectively satisfied its reach and potential impact on advancing prostate cancer research and treatment options for patients near and around the University of Minnesota, they conclude.