Vikie Lamontagne, agente de recherche — réglementaire (Urologie-Oncologie, CRCHUM); Dr Fred Saad, chercheur au CRCHUM et uro-oncologue au service d’urologie du CHUM; et Amal Nadiri, chargée de projet (Urologie-Oncologie, CRCHUM)
A clinical team from the CHUM Research Centre (CRCHUM) has positioned our facility as the first site worldwide to be activated for the PanTHA study, a Phase 1 clinical trial for advanced prostate cancer conducted by the pharmaceutical company Bayer. Through its sustained efforts, it has also facilitated the recruitment of the world’s first patient for this study.
This world first was made possible by the use of the FAST TRACK Evaluation Service provided by our partner CATALIS. This was the first time Bayer had used this service.
Congratulations to the team involved, including Dr. Fred Saad, CRCHUM researcher and uro-oncologist at the CHUM, Vikie Lamontagne, regulatory coordinator (Urology-Oncology, CRCHUM) and Amal Nadiri, site manager (Urology-Oncology, CRCHUM).
"We are very proud to have been able to activate this Phase 1 study in record time, particularly given the complexity of a clinical trial assessing a new agent targeting advanced prostate cancer. This new treatment gives hope to patients who have exhausted virtually all available therapeutic options to prolong their lives", said Dr. Saad.
- PanTHA study approval in 10.4 weeks
- Site activation in 12.2 weeks
With this Phase I trial, Bayer hopes to find a better way to treat people with mRCC, an advanced prostate cancer that has spread to other parts of the body and does not respond to metastatic castration, which is the hormonal treatment usually used to lower testosterone level and prevent cancer growth.
The PAnTHA study aims to assess the safety, tolerance, pharmacokinetics, and preliminary efficacy of 225Ac-PSMA-Trillium, a targeted alpha therapy that is a new class of agents currently in clinical development.
The trial aims to recruit 34 patients, including 7 in Quebec.
To find out more about the clinical trial
Visit the dedicated page on Clinical Trials Quebec
To find out more about the FAST TRACK Evaluation Service
The CATALIS network’s FAST TRACK Evaluation Service, of which CHUM is one of the three founding hospitals, aims to authorize clinical trials in ≤ 8 weeks, a reduction of nearly 75% compared to the standard authorization time.
Through the FAST TRACK Evaluation Service, CATALIS hopes to contribute to the optimization of the clinical research environment in Quebec and to the acceleration of the development of innovative treatments, for the benefit of patients.
Source of the news: website of our partner Catalis.
Catalis is a non-profit partnership dedicated to the advancement and operational excellence of clinical research in Quebec.
