The CHUM Authorizes a Novartis Study on Prostate Cancer With the Support of the FAST TRACK Evaluation Service and Recruits the First Patient Worldwide
Novartis used the FAST TRACK Evaluation Service for its phase III study, PSMA-DC, which aims to assess the efficacy and safety of lutetium vipivotide tetraxetan (AAA617) in patients whose prostate cancer has advanced to an oligometastatic stage despite treating the primary tumour.
Dr. Cynthia Ménard at the Centre hospitalier de l’Université de Montréal (CHUM) and Dr. Mohammad Tamim Niazi at the Jewish General Hospital (JGH) took part in this study. The CHUM was the first site to start the trial and received approval in 9.4 weeks. This made it the first site to be activated in Canada, the 6th site worldwide and the first to recruit a patient in this study worldwide. This positioned it ahead of 125 other sites in 26 countries.
The JGH also authorized this study in 8.8 weeks, positioning it as the 2nd site activated in Canada and the 7th one worldwide.
“Novartis Canada is proud to be one of the first sponsors to partner with CATALIS. Through this partnership, we have successfully conducted a radioligand therapy trial for the PSMA indication. By using the CATALIS FAST TRACK Evaluation Service, we were able to initiate the trial earlier, with the added milestone of the first patient visit in Canada. This achievement underscores the importance of efficiency and effectiveness in clinical trials and demonstrates Quebec’s commitment to accelerate clinical trials. We are confident that this ongoing collaboration will continue to deliver value and further demonstrate our commitment to advancing research that will have a positive impact on patients and their families.”
– Mark Vineis, Country President, Novartis Canada
Healthcare Institutions Pioneering Excellence in Prostate Cancer Research in Quebec
At the CHUM, Dr. Ménard’s research team is working to improve radiation therapy for prostate cancer patients. The CHUM has an ecosystem of health professionals who have made considerable scientific advances in treating this cancer. Most notably, Dr. Ménard and her team have developed an imaging technique that locates the spread of cancer more effectively than traditional methods, allowing radiation therapy to be better adapted to patients.
Dr. Mohammad Tamim Nazi and his team conduct their research on the development of new treatments for genitourinary cancers at the JGH’s Lady Davis Institute. The Lady Davis Institute is recognized for its excellence in cancer research and is home to the largest group of oncology clinician-researchers in Quebec.
The PSMA-DC Study: Targeted Radiation Therapy to Slow the Progression of Prostate Cancer
Prostate cancer is the most common cancer in Canadian men and the third leading cause of death by cancer worldwide¹. Despite advances in diagnosing and treating it, its frequency and associated mortality are increasing, mainly due to the aging population. About 10-20% of patients develop metastatic prostate cancer², where prostate cancer cells migrate to other organs to form metastases. Among metastatic cancers, oligometastatic cancer is characterized by the spread of cancer cells to a limited number of sites. Affected patients receive systemic treatments such as chemotherapy or hormone therapy, which lowers testosterone to slow down the cancer’s progression but causes side effects such as fatigue, loss of libido, and metabolic disorders.
Customized and targeted approaches have recently made headway in countering these effects. In Novartis’ PSMA-DC study, AAA617 is a targeted form of radiation that distributes beta radiation directly to cancer cells, allowing for the destruction of diseased cells while minimizing damage to surrounding healthy tissue. The study will show whether the AAA617 treatment can slow tumour progression while preserving patients’ quality of life and delaying the use of hormone therapy. The study aims to recruit 450 participants worldwide, including 12 in Quebec.
“At PROCURE, we are deeply impressed by the commitment of the Quebec research teams and the effectiveness of the FAST TRACK Evaluation Service. The recruitment of the world’s first patient in the Novartis PSMA-DC trial represents tangible hope for prostate cancer patients. Accelerating access to innovative treatments is essential to providing better treatment options and improving patients’ quality of life. This collaboration between researchers, clinicians and healthcare organisations puts Quebec at the forefront of innovation in the fight against prostate cancer, and we are proud to support this breakthrough.”
– Ann-Marie Romanin, Director, Patient Services & Medical Relations, PROCURE
Are you interested in participating in this clinical trial or in other studies on prostate cancer? We offer a free Personalized Support Service to help guide you in your search for clinical trials. You can also access Clinical Trials Quebec’s information and services hub. This site contains easy-to-understand educational content, graphics, and free tools which will help you to better understand clinical research and what happens during a clinical trial.
Patients at the Heart of the CATALIS Quebec Network’s Mission and of its FAST TRACK Evaluation Service
Thanks to the commitment of the CHUM, the JGH, and Novartis, CATALIS and its Network of Partners are delighted to stimulate innovation in clinical research and the development of treatments that could improve the lives of patients in Quebec.
CATALIS would also like to thank all its public and private partners for their trust, their participation in developing innovative clinical research approval methods, and their commitment to implementing accelerated clinical trials in their institutions.
If you would like more information about the FAST TRACK Evaluation Service, please write to us at: info@catalisquebec.com.
¹Canadian Cancer Society (2024). Prostate Cancer Statistics. Available at: https://cancer.ca/en/cancer-information/cancer-types/prostate/statistics
²Oka R, Utsumi T, Noro T, Suzuki Y, Iijima S, Sugizaki Y, et al. Progress in Oligometastatic Prostate Cancer: Emerging Imaging Innovations and Therapeutic Approaches. Cancers. Jan 2024; 16(3):507.
