LOS ANGELES, Calif., January 11, 2024 — New analysis of data published by Susan Halabi, PhD, of Duke University, USA could facilitate approval of new prostate cancer treatments almost two years earlier than the current standard.
The study published online January 5, 2024, in the Journal of Clinical Oncology, reviewed data from over 8,500 men in nine different clinical trials. It showed that the length of time a man lives without his cancer progressing – known as ‘progression-free survival’ – reasonably predicts how long he will eventually live (‘overall survival’). The research was funded by the Prostate Cancer Foundation and Prostate Cancer UK and led by Professor Susan Halabi, PhD, co-Chief, Division of Biostatistics, and the James B. Duke Distinguished Professor of Biostatistics and Bioinformatics at Duke University School of Medicine, and supported by the Duke University and the MRC Clinical Trials Unit at University College London (UCL).
Dr. Halabi said: “Prostate cancer readout in men with metastatic prostate cancer can take a decade if survival is used as the main outcome. This result highlights the importance of performing this analysis and maximizing the use of data from globally collected clinical trials. While the results are promising, the goal is to go one step further and demonstrate the benefit of using these valid intermediate endpoints in contemporary treatments to the U.S. Food and Drug Administration and other regulatory agencies. “
“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 treatments to men even more quickly in the future,” she continued.
Professor Jayne Tierney (MRC Clinical Trials Unit at UCL), who was involved in the research, said: “This is a clear example of how a worldwide collaborative effort to share and re-use the valuable data from existing clinical trials can reap rewards for future patients.”
On average, progression-free survival can be assessed around two years earlier than overall survival, meaning that future trials could be shorter and new treatments could reach men safely, and more quickly than is currently possible.1
Charles J. Ryan, M.D., Chief Executive Officer of the Prostate Cancer Foundation said, “This innovative implementation of clinical trial data to identify an early milestone of prolonged survival promises to accelerate new therapy development, key to fulfilling our mission of reducing death and suffering from this disease. “
The team is now working to understand whether other earlier measures could be used to predict overall survival, which could further shorten the length of time needed for clinical trials.
- Halabi S, Roy A, Rydzewska L, Guo S, Godolphin P, Hussain M, Tangen C, Thompson I, Xie W, Carducci MA, Smith MR, Morris MJ, Gravis G, Dearnaley DP, Verhagen P, Goto T, James N, Buyse ME, Tierney JF, Sweeney C; STOPCAP/ICECaP Collaboration. Radiographic Progression-Free Survival and Clinical Progression-Free Survival as Potential Surrogates for Overall Survival in Men With Metastatic Hormone-Sensitive Prostate Cancer. J Clin Oncol. 2024 Jan 5:JCO2301535. doi: 10.1200/JCO.23.01535. Epub ahead of print. PMID: 38181323.
About the project
The multi-national research project was led by Susan Halabi, PhD, at Duke University and supported by the MRC Clinical Trials Unit at University College London on behalf of the STOPCAP Collaboration, funded by the Prostate Cancer Foundation and by the UKRI Medical Research Council and Prostate Cancer UK. Prostate Cancer Foundation and Prostate Cancer UK funding of $500,000 and £465,180 were awarded through a Research Innovation Award.
About Prostate Cancer Foundation
The Prostate Cancer Foundation (PCF) is the world’s leading philanthropic organization dedicated to funding life-saving prostate cancer research. Founded in 1993 by Mike Milken, PCF has been responsible for raising more than $1 billion in support of cutting-edge research through more than 2,250 research projects at 245 leading cancer centers, with a global footprint spanning 28 countries. Since PCF’s inception, and through its efforts, patients around the world are living longer, suffering fewer complications, and enjoying better quality of all life. PCF is committed to creating a global public square for prostate cancer, in service to our mission of ending death and suffering from the disease. Learn more at pcf.org.
About Prostate Cancer UK
Prostate Cancer UK has a simple ambition – to stop prostate cancer damaging the lives of men and their families.
Investing into finding better treatments and tests that could save thousands of lives.
Working with the NHS to make sure men get access to breakthrough tests and treatments.
Spreading the word about who is at risk of prostate cancer, especially to those at higher risk.
Supporting people dealing with prostate cancer and providing health information.
Visit prostatecanceruk.org now to help beat this disease.
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