Curasight advances Phase 2 uTRACE prostate cancer trial with all European clinical sites in Part 2 now recruiting
October 29, 2025
· Part 1 of the trial is completed
· Part 2 recruitment well underway; completion expected in the first half of 2026
· The Phase 2 study in prostate cancer is part of the agreement between Curium Inc. and Curasight signed in May 2023
Copenhagen, Denmark, 29 October 2025 - Curasight A/S ("Curasight" or the “Company" - TICKER: CURAS) announces today strong momentum in part 2 of the Phase 2 Study investigating the company’s diagnostic platform uTRACE® in prostate cancer. All nine sites across Germany, Sweden and Denmark are now fully activated and recruiting patients following the completion of part 1 of the study earlier in 2025.
This milestone illustrates Curasight’s operational execution and marks an important step towards establishing uTRACE® as a novel non-invasive imaging tool to provide better diagnosis and risk stratification of prostate cancer patients.
The Phase 2 study is being run under the strategic collaboration with Curium Inc., a global leader in nuclear medicine. Under the agreement Curasight is eligible for up to USD 70 million in milestone payments and double-digit percentage royalties upon commercialization of uTRACE®.
“We are very pleased with the progress of the uTRACE program in prostate cancer,” said Curasight CEO Ulrich Krasilnikoff. “Part 1 supported the feasibility of our imaging approach and with all clinical sites now activated in the second part of the trial, we expect to recruitment completed in the first half of 2026”.
As well as the Phase 2 study in prostate cancer, Curasight anticipates launching a Phase 1 trial testing its therapeutic platform uTREAT® in brain cancer during the current quarter.
About the Phase 2 trial with uTRACE® in prostate cancer
The phase 2 trial evaluates Curasight’s first-in-class PET tracer, 64Cu-DOTA-AE105 (uTRACE) as a non-invasive grading tool for assessing tumor aggressiveness in prostate cancer patients managed under active surveillance. Patients are monitored over time for changes in their tumor biology, with imaging of uTRACE helping clinicians to better distinguish indolent from aggressive disease and potentially reducing unnecessary treatment and improving patient outcomes. The trial design is informed from research and earlier studies with uTRACE® as well as protocol discussions with the US Food and Drug Administration (FDA).
About Curasight’s theranostic platform
Curasight’s radiopharmaceutical theranostic platform builds on uPAR-targeting peptides labelled either with radioisotopes suitable for imaging, uTRACE®, or labelled with radioisotopes suitable for radioligand therapy, uTREAT®. The target, uPAR, is expressed in the majority of solid tumors and is a marker of cancer aggressiveness.
For more information regarding Curasight, please contact:
Ulrich Krasilnikoff, CEO
Phone: +45 22 83 01 60
E-mail: [email protected]