IRONMAN Trial Enrolling Prostate Cancer Patients

Daniel George, MD

The International Registry for Men with Advanced Prostate (IRONMAN), the first international clinical trial registry for prostate cancer, is open for enrollment. The registry aims to enroll 5,000 patients over the next three years at several institutions worldwide, including 2,500 from the United States and Canada. 

The international clinical trial registry is led by Daniel George, MD, professor of medicine and surgery and director of genitourinary oncology at Duke Cancer Institute, Philip Kantoff, MD chairman of medicine at Memorial Sloan Kettering Cancer Center and Lorelei Mucci, ScD, associate professor of epidemiology at the Harvard T.H. Chan School of Public Health and leader, cancer epidemiology Dana-Farber/Harvard Cancer Center.

George, Kantoff and Mucci initiated the IRONMAN registry to address the knowledge gaps around care and sequential therapy for patients with advanced prostate cancer. This large, international registry encompasses a prospective collection of clinical data, multiple blood samples with treatment changes, physician questionnaires, and a longitudinal collection of patient-reported outcomes (PROs).

“IRONMAN is a groundbreaking study that will observe how men with advanced prostate cancer are treated and how they suffer,” explained George. “By documenting where we are coming up short, we should be able to improve our care for these patients. From a biology perspective, prostate cancer is challenging because it is not one disease; there are many different changes in the genes that make up prostate cancer in each patient. Therefore, we urgently need to understand how genetics of advanced prostate cancer predict treatment response.” 

By developing an international population-based registry, IRONMAN will help advance the clinical understanding of the variation in care and treatment of advanced prostate cancer across academia and community-based practices worldwide. The registry will allow researchers to assess specific treatment patterns while identifying unmet needs of patients during their treatments. Study sites, with principal investigators, include Australia, Brazil, Canada, Ireland, South Africa, Sweden, Switzerland, the United Kingdom and the United States.

“We are at a tipping point; results from this study will have an immediate and significant impact on patient care,” George said. “Through IRONMAN, we can jumpstart the use of genetic profiles to guide prostate cancer treatment decisions. If successful, we will create data that could inform clinical trial design and patient selection, as well as alter how we evaluate patients in clinical practice.”

Prostate cancer is the leading cause of cancer death in 29 countries, and 366,000 men die of this disease globally each year, with most deaths occurring due to metastatic castration-resistant prostate cancer.

“Stage IV castration-resistant prostate cancer is the lethal clinical phenotype of the disease and responsible for the vast majority of prostate cancer related deaths,” said George. “Although progress has been made in the last seven years with the approval of six different therapies to prolong survival, little progress has been made in the areas of precision medicine and symptom management. We are dedicated to changing the rules on cancer, and IRONMAN will help drive global advancements in treatment to combat this issue.”

IRONMAN receives the greatest amount of funding from the Movember Foundation, but also receives support from pharmaceutical companies. If interested in learning more, visit IRONMAN.