The Research Institute of McGill University Health Centre (RI-MUHC) has enrolled this week the first patients to take part in an early-stage, multi-centre clinical trial of Actinium-225, a radioactive isotope used as a treatment for metastatic prostate cancer. The RI-MUHC is proud to be selected as the first site worldwide to launch this new clinical trial, which introduces a promising new therapy in precision medicine for patients who have exhausted all other options in the treatment of their disease.
The third leading cause of cancer-related-death in men, prostate cancer will affect approximately 1 in 8 Canadian men during their lifetime and cause the death of one in 30, according to the Canadian Cancer Society.
Led at the RI-MUHC by 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, the study will evaluate the safety (i.e. the drug’s ability to act without adverse effects) and tolerability (i.e. the subject’s ability to withstand adverse effects) of Actinium-225, which works by targeting the prostate-specific membrane antigen (PSMA).
PSMA, which is found in more than 80 per cent of patients with metastatic prostate cancer, is highly expressed in prostate tumoral cells, but is very little present in the rest of the body. Actinium-225 binds to PSMA receptors, finds the cancer cells and emits radiation to kill them by breaking their DNA strands. A potential advantage of this targeted mode of action is the sparing of healthy organs.
“We are very excited to be testing Actinium-225 and to be the first centre in the world to start this clinical trial,” says Dr. Saleh. “It’s a great satisfaction for our team because it’s the result of our sustained efforts to bring the latest therapeutic advances to our patients.”
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 of care treatments have failed. Different doses will be tested and patients will be followed for five years to monitor any side effects.
In addition to assessing the safety of the drug for patients, the study will monitor how the drug interacts with tumours and healthy organs, find out if it is well tolerated, and determine the right dose that could be used in future studies.
“Other clinical trials have shown that similar treatment with drugs that target PSMA can reduce prostate cancer tumour burden and potentially improve prognosis. So, although we don’t know if the drug we’re studying will improve the health of our patients, we see this trial as our best hope,” adds Dr. Saleh, who is also Medical Director of the Phase 1 Research Unit at the CIM, Investigator in the Cancer Research Program at the RI-MUHC and Assistant Professor in the Gerald Bronfman Department of Oncology at McGill University.
Clinical trials: the path to better health outcomes
Research is essential to improve cancer treatments and survival rates. Phase 1 clinical trials are a critical part of research, because they can determine whether to continue or stop development of a new drug.
Established in 2018, the Phase 1 Research Unit at the CIM is dedicated to providing high-quality care to its cancer patients while supporting the drug development process. One of the distinguishing elements of the unit is its state-of-the-art facilities and equipment, which allow for precise and efficient study conduct. In addition, the unit often works with a multidisciplinary team of experts to ensure comprehensive and robust clinical trial designs.
“This world first confirms that the RI-MUHC, by fostering collaboration between its researchers and industry experts, has established a leadership position in Canada’s clinical trials ecosystem. The Centre for Innovative Medicine not only brings the latest experimental therapies to patients, but also attracts the most innovative pharmaceutical companies, both nationally and internationally, at every stage of clinical trials,” says Dr. Louise Pilote, Director (interim) of the CIM and Deputy Director of the RI-MUHC.