Curium has announced the completion of enrollment for its Phase 3 SOLAR-RECUR clinical trial. This multicenter, open-label study is designed to evaluate the diagnostic performance of copper Cu 64 PSMA I&T PET/CT in men experiencing suspected biochemical recurrence of prostate cancer following radical prostatectomy or radiation therapy. The company is also continuing enrollment for its SOLAR-STAGE trial, which assesses the same imaging agent in staging newly diagnosed prostate cancer.
SOLAR-RECUR Trial Details
The SOLAR-RECUR trial (NCT06235099) enrolled patients across over 30 sites in the U.S. The study focuses on individuals who have undergone radical prostatectomy or radiation therapy and are suspected of having a biochemical recurrence of prostate cancer, indicated by a rising PSA level. The primary endpoint is to determine the accuracy of Cu 64 PSMA I&T PET/CT in detecting sites of recurrence.
SOLAR-STAGE Trial Expansion
The SOLAR-STAGE trial (NCT06235151) is actively enrolling patients in the U.S. and will soon expand to sites in Europe. This trial evaluates the diagnostic performance of copper Cu 64 PSMA I&T PET/CT in staging men with newly diagnosed unfavorable intermediate-risk, high-risk, or very-high-risk prostate cancer who are electing to undergo radical prostatectomy with pelvic lymph node dissection.
Executive Perspectives
Sakir Mutevelic, MD, Curium’s Chief Medical Officer, stated that the completion of SOLAR-RECUR enrollment is a significant milestone for Curium. He emphasized that Cu 64 PSMA I&T is a crucial component of their theranostic program for prostate cancer patients. Amy Bartalotta, Vice President of Clinical Operations, added that Curium aims to expand its Cu 64 diagnostic imaging platform to increase PSMA PET access for healthcare providers and patients nationwide.
About Cu 64 PSMA I&T
Cu 64 PSMA I&T is a PET imaging agent that targets Prostate-Specific Membrane Antigen (PSMA), a protein highly expressed on prostate cancer cells. By targeting PSMA, this diagnostic tool aims to improve the detection and localization of prostate cancer, potentially leading to more informed treatment decisions.
Curium's Commitment
Curium is dedicated to advancing nuclear medicine through the development, manufacture, and distribution of radiopharmaceutical products. With manufacturing facilities in Europe and the United States, Curium provides SPECT, PET, and therapeutic radiopharmaceutical solutions for life-threatening diseases, serving over 14 million patients annually.
