Movember project aims to speed up clinical trials by two years, get new treatments to men sooner
New prostate cancer treatments could reach men two years sooner, thanks to a Movember-supported project that is aiming to speed up prostate cancer trials worldwide.
It is hoped that new research by Dr Susan Halabi, Professor of Biostatistics and Bioinformatics at the Duke University School of Medicine, presented at the American Society of Clinical Oncology (ASCO) Meeting in Chicago on June 5, 2022, could allow new prostate cancer treatments to be approved almost two years earlier than is currently possible.
Dr Halabi’s research, which was funded through a PCF-Movember Foundation Challenge in 2018, analysed data from over 8,500 men in 9 different trials. It showed that the length of time that a man lives without his cancer progressing (known as ‘progression-free survival’), can reasonably be used to predict how long he will eventually live (also known as ‘overall survival’).
On average, progression-free survival can be assessed around two years earlier than overall survival, meaning that future trials could be shorter, and that new treatments could reach men safely, and more quickly than they do currently.
Dr Sarah Hsiao, Director of Biomedical Research and Impact at Movember, said: “Developing a new cancer treatment often takes many years, partly due to the length of time it takes to see how effective the treatment is in clinical studies. Dr Halibi’s research has the potential to slash that time by using a different method of determining how effective the treatment is.
" As it stands, it has massive implications for future prostate cancer trials – saving time, money, and most importantly lives. "
“We look forward to the validation on the use of progression-free survival to inform treatment efficacy, allowing men with prostate cancer to access new treatments sooner.”
Dr Halabi said: “The readout from phase III clinical trials in men with hormone sensitive metastatic prostate cancer can take a decade if survival is used as the primary outcome. This analysis highlights the importance of identifying intermediate markers of survival and underscores the maximal use of data collected from global clinical trials. While the results are promising, the goal is to go one step further and demonstrate to NICE, the US Food and Drug Administration and other regulatory agencies the value of using these surrogate outcomes in new studies. “
“As it stands, it has massive implications for future prostate cancer trials – saving time, money, and most importantly lives – by helping them prove a treatment’s effectiveness sooner. We hope that this is just the first step, and we can find ways to get effective treatments to men even more quickly in the future.”
Charles Ryan, MD, President and CEO at the Prostate Cancer Foundation, said: “These results improve our understanding of the natural history of prostate cancer and, more importantly, may help shorten the timeline of critical clinical trials that are needed to bring new therapies to the clinic.”
The team is now working to determine whether other earlier measures could be used to predict overall survival, which could further shorten the length of time needed for randomized phase III trials.
The multi-national research project was led by Dr Halabi on behalf of the STOPCaP Collaboration, with funding from Movember, Prostate Cancer Foundation, the UKRI Medical Research Council and Prostate Cancer UK.
The STOPCaP project is part of ICECaP, a global consortium of researchers and patient representatives, aimed at developing a collaborative strategic approach to reducing deaths from prostate cancer worldwide.