Phase 1/2 Trials Begin for PSMA-R2 Compounds Being Tested for Prostate Cancer Treatment, Diagnostics

Phase 1/2 Trials Begin for PSMA-R2 Compounds Being Tested for Prostate Cancer Treatment, Diagnostics
Two Phase 1/2 clinical trials testing PSMA-R2-based treatment and diagnostic candidates for prostate cancer have begun dosing their first patients, Advanced Accelerator Applications (AAA) announced in a press release. PSMA-R2 is a urea-based radioligand — a radioactive-labeled biochemical compound — of the protein prostate-specific membrane antigen (PSMA), which is frequently overproduced in prostate cancer cells. It is part of AAA’s theragnostic platform, a strategy that integrates diagnostics and therapeutics for cancer management. "Advancing PSMA-R2 into clinical studies is a major milestone for AAA," Germo Gericke, MD, head of research and development at AAA, said in the release. "We are eager to explore the full potential of this innovative platform in large patient populations, such as prostate cancer." The open-label, multicenter PROter trial (NCT03490838) is assessing 177Lu-PSMA-R2 for the treatment of patients with PSMA-positive, metastatic, castration-resistant prostate cancer, who received previous systemic treatment. The study will assess the treatment's safety, tolerability, and radiation dosimetry (the dosage absorbed by the body), while also further evaluating its effectiveness. While the first part of the trial will establish the recommended dose of 177Lu-PSMA-R2, the second part will mainly assess preliminary anti-tumor response of repeated treatments and determine the treatment's safety and patients’ quality of life. Other goals include measuring prostate-specific antigen (PSA) response, a common method to monitor treatment effectiveness; time to PSA progression, which correlates with disease progression; and overall survival. Enrollment — estimated at a total of 96 patients — is currently ongoing. For more infor
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