A less expensive, more accessible, and comfortable alternative exists for those facing a prostate cancer biopsy, according to findings from a new clinical trial that Yale Urology contributed to.

Authors say OPTIMUM, the first head-to-head trial comparing micro-ultrasound-guided versus MRI-guided biopsies, signifies a breakthrough in image-guided treatment.

Potentially Practice Changing

“I believe this could change the way clinics practice,” says Joseph Renzulli II, MD, one of the co-investigators of the trial and associate professor of urology at Yale School of Medicine.

According to results published in JAMA on March 23 and presented at the European Association of Urology’s annual meeting the same day, high-resolution micro-ultrasounds [microUS] were shown to be just as effective as MRIs—the current standard of identifying where to biopsy the prostate when cancer is suspected.

The microUS provides a high-resolution ultrasound view of the prostate gland through a probe that is inserted through the rectum. It is generally not painful, but numbing agents may be used to alleviate any discomfort.

The OPTIMUM trial, which concluded in fall 2024, enrolled just over 800 participants across 20 medical centers in eight countries.

“We have been able to show there’s another option for the prostate cancer workup,” says Joseph Brito III, MD, associate professor of urology at Yale School of Medicine, who was also part of the study and co-authored the recent JAMA manuscript. “The patient doesn’t always need an MRI.”

MRI Alternative

Brito and Renzulli say the findings are significant. MRIs are considerably more expensive than high-resolution ultrasounds. They can provoke claustrophobia, pose problems for those with metal implants and pacemakers, and are less accessible in smaller or non-academic hospitals and centers.

“I think we underestimate the difficulty for patients and how emotionally impactful it is to hear there’s an area of concern and then have to wait for the actual biopsy procedure,” says Renzulli.

Once a physician orders an MRI, it can take four to six weeks or longer before it is scheduled. Patients will then undergo the separate biopsy procedure.

Simultaneous View and Biopsy

A microUS is done during the biopsy, helping to guide the surgeon in real time.

“An ultrasound biopsy saves an entire intermediate step and helps with that anxiety component,” says Brito.

Yale Urology Chair Isaac Y. Kim, MD, PhD, who is also a member of Yale Cancer Center and co-leads their Cancer Signaling Networks program, says this is the type of research Yale is all about. “We want to engage more in collaborative innovation that has the potential to change care in the clinic and address the real needs of our patients.”

A total of 802 men who were suspected to have some form of prostate cancer were randomly assigned to receive a microUS, an MRI and conventional ultrasound, or a microUS and MRI. Authors of the study say the differences were not significant and determined the microUS-guided biopsies were “noninferior” or similar to both the MRI-guided biopsies and the combined MRI-conventional ultrasound-guided biopsies.

Collaborative Next Steps

Members of the OPTIMUM trial team say they hope the study will bring them one step closer to identifying disease and treating or managing it simultaneously.

“I think the ideal is creating both a diagnostic and therapeutic approach,” says Renzulli. “That’s the next step in this research.”

Renzulli and Brito collaborated with first author Adam Kinnaird, MD, PhD, with the University of Alberta, Edmonton, Canada, along with 22 other researchers across the globe.