The Research Institute of McGill University Health Centre (RI-MUHC) has enrolled the first patients in a new global Phase 1 clinical trial testing Actinium-225, a therapeutic agent used in nuclear precision medicine for treating metastatic prostate cancer. This marks the RI-MUHC as the first site worldwide to launch this clinical trial, offering a promising new therapy for patients who have no other treatment options.
Prostate cancer is the third leading cause of cancer-related death in men, affecting approximately 1 in 8 Canadian men during their lifetime and causing the death of 1 in 30, according to the Canadian Cancer Society.
Dr. Ramy Saleh, Medical Oncologist at the MUHC’s Cedars Cancer Centre and Medical Director, Oncology, at the Centre for Innovative Medicine (CIM) at the RI-MUHC, leads the study. It will evaluate the safety and tolerability of Actinium-225, which targets the prostate-specific membrane antigen (PSMA) found in more than 80 percent of patients with metastatic prostate cancer. Actinium-225 binds to PSMA receptors, locates cancer cells, and emits radiation to kill them by breaking their DNA strands, potentially sparing healthy organs.
The experimental treatment, developed by the US company POINT Biopharma, will be administered by intravenous injection to 50 patients with metastatic castration-resistant (mCRPC) or biochemically recurrent (BCR) prostate cancer, for whom standard treatments have failed. The study will test different doses and follow patients for five years to monitor side effects, assess the drug's interaction with tumours and healthy organs, and determine the appropriate dose for future studies.
Dr. Saleh expressed excitement about the trial, highlighting it as a result of sustained efforts to bring the latest therapeutic advances to patients. The Phase 1 Research Unit at the CIM, established in 2018, supports the drug development process with state-of-the-art facilities and a multidisciplinary team of experts, ensuring comprehensive and robust clinical trial designs.
Dr. Louise Pilote, Director (interim) of the CIM and Deputy Director of the RI-MUHC, emphasized the institute's leadership in Canada’s clinical trials ecosystem, fostering collaboration between researchers and industry experts to bring the latest experimental therapies to patients and attract innovative pharmaceutical companies.
The RI-MUHC is a world-renowned biomedical and healthcare research centre affiliated with McGill University, supporting over 600 researchers and close to 1,700 research trainees. It focuses on improving the health of individual patients through a dynamic multidisciplinary environment that fosters collaboration and leverages discovery.
