MCC-led global trial for new prostate cancer treatment launched in record time
For the thirty-plus years that we’ve existed, doctors, researchers, and other advocates at the Masonic Cancer Center (MCC), University of Minnesota have been making history. Every new study, clinical trial, and method for stomping out cancer that our team creates helps us write another page in cancer’s last chapter and ensure that all survivors thrive. And now we’re celebrating another history-making achievement!
Doctors and research staff at MCC were the first in the world to launch a promising clinical trial for a brand-new prostate cancer treatment—and we did it in record time.
What is the trial for?
The trial is a first-in-human Phase 1 study testing an experimental pill called ACE-232 in people with advanced prostate cancer that has returned despite prior hormonal therapies and chemotherapies. The goal? Find a new way to slow or stop the disease when other treatments have failed. Need a refresher on the phases of clinical trials? Revisit our "What are cancer clinical trials?" explainer.
This trial is led by MCC’s Dr. Emmanuel Antonarakis, a prostate cancer expert who serves as our associate director of translational research and is also a professor of medicine at the U of M Medical School. Dr. Antonarakis has worked closely with biotech company Acerand Therapeutics to design the study and serves as the global principal investigator, or PI.
“This is the first time in my career that we’ve been the first center in the world to open a global Phase 1 trial,” said Dr. Antonarakis, adding: “It’s a moment to celebrate the team that made this happen.”
From start to finish, the study went from planning to launch in just 66 days, a huge accomplishment in cancer research! Clinical trials often take months to activate, but this one moved at top speed thanks to a high-performing team. “The urgency to open clinical trials comes from the pivotal role they play in evaluating the safety and effectiveness of new treatments that advance medical knowledge and improve care and outcomes for our patients,” said Dedra Schendzielos, MHA, MCC’s executive director for clinical research.
How the Fast-Track initiative is meeting the moment
MCC's Clinical Trials Office (CTO) developed its FastTrack initiative in 2023 to meet industry demand to rapidly open trials. FastTrack studies follow the same processes as all other studies with higher levels of team engagement to meet tighter project milestones and accelerated startup deadlines.
Special credit for fast-tracking this trial goes to CTO team members who work with the PI, sponsor, and multiple stakeholders across the University of Minnesota to open a trial to accrual (when patients start enrolling in the trial). Ashley Vogt, CTO program manager for prostate cancer trials, managed the study through the startup process with the support of study team members like research RNs Neha Patel and Kaitlyn Reus, clinical research coordinators Beth Mollen, Skylar Mast, and Aleena Rehman, and regulatory specialist, Jazz Crosby, who worked behind the scenes to make it all happen.
“It was really exciting to see this timeline come together, and I am so appreciative of the commitment from our highly driven sponsor and our nimble CTO team who took action to maintain the momentum of our accelerated timeline,” said Ashley Vogt.
This oral therapy targets a protein known to researchers as CYP11A1, which plays a key role in producing hormones that fuel prostate cancer growth. By blocking this protein, the therapy, ACE-232, could slow cancer in patients who no longer respond to standard hormone treatments or chemotherapy drugs. The fact that the new medication can be taken as a pill is a major advantage, eliminating the need for injections or infusions.
“Launching this global study here at MCC means our patients have early access to a promising new option before anyone else in the world,” says Dr. Antonarakis. “And, it puts our cancer center on the map as a leader in accelerating cancer research.”
“This kind of achievement does not happen by accident,” said Dr. Melissa Geller, associate director of clinical research at MCC and a professor with the U of M Medical School. “It is a result of an incredibly dedicated and collaborative team that understands what is at stake for patients waiting for next-generation therapy options. The FastTrack initiative is laying the foundation for more innovative studies to move forward quickly, bringing us closer to the discoveries that can truly make a difference in patients’ lives.”
“This is more than just a trial. It’s a bold step forward for science, for global collaboration, and most importantly, for everyone who has advanced prostate cancer,” Dr. Antonarakis adds.
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