The ProtecT Trial, funded by the National Institute for Health and Care Research, showed that Active Monitoring of all low- and many intermediate-risk prostate cancers was safe and that death rates were essentially the same whether the men were assigned to surgery, or radiation, or were followed with what is now known as Active Surveillance.
Freddie Hamdy CBE, Head of the Nuffield Department of Surgical Sciences at the University of Oxford and lead investigator of the ProtecT Trial, said: 'I want to say how touched I am for the ProtecT team by this generous award and recognition of our work by ASPI, and what a wonderful surprise it is. It feels so very special to be recognised by the very people we have been trying to help.'
'We started ProtecT over 25 years ago, because we wanted to help patients with PSA-detected prostate cancer to decide what treatment to choose, which can be daunting, by providing high-quality evidence, and importantly measuring and analysing patient-reported outcomes alongside the clinical outcomes of our trial. We did not know what to expect. But with our findings, we do believe that it now allows men to consider all options, and to have confidence in Active Surveillance when appropriate.'
Jenny Donovan PhD, of the University of Bristol and co-lead investigator, added: 'I am also absolutely thrilled and honored that we have been nominated for this ASPI Special Award. We set out all those years ago, involving patients at every stage of the study, to provide high-quality information about the trade-offs that are needed when making the decision about which treatment pathway to follow.'
The ProtecT team recently published the 15-year clinical and 12-year patient-reported outcomes of the study in the New England Journal of Medicine. Researchers reported on 1,643 patients. After an average 15 years of follow-up, prostate cancer–specific mortality was low (around 3%) regardless of the treatment assigned. The study also reported that there was an increased risk of cancer spread with Active Monitoring, and side-effects following surgery and radiotherapy that included urinary leakage and impaired sex life over at least 12 years.
Mark Lichty, co-founder and chairman of ASPI, said: 'ProtecT has been a game-changer for tens of thousands of men who decide to go on AS with confidence about safety with appropriate surveillance.'
He added, 'ProtecT proved that Active Surveillance, close monitoring of lower-grade prostate cancers, can spare men from unnecessary treatment and protect their quality of life.'
Paul Schellhammer, MD, a member of the ASPI awards committee, a urologist, and a prostate cancer patient, said: 'The ProtecT Trial accomplished a scientific feat, which overcame two of the greatest obstacles in the advancement of knowledge of prostate cancer therapy - first, a randomised control trial involving three different therapies and second, the extraordinary15-year follow with survival and quality of life data. The full spectrum of medical care and medical inquiry personnel, nurses, counselors, physicians, and statistical and social scientists are to be congratulated and appropriately honored.'
Schellhammer also is past president of the American Urological Association.
The project team will receive an original painting by artist Kathy Lockwood, symbolising how patients and physicians can work together to “First, Do No Harm” (Hippocrates) and preserve patients’ quality of life.
In 2023, Michigan Urological Surgery Improvement Collaborative (MUSIC) received ASPI’s first Special Award. MUSIC has shown that by virtually all urologists in Michigan working together, Active Surveillance uptake in men with low-risk prostate can could exceed 90%, comparable to the highest AS rates in the world. The U.S. uptake of AS in the low-risk population is about 60%.
The ASPI Awards committee included Lichty and Schellhammer along with Robin Chodak, widow of pioneering prostate researcher the late Gerald Chodak, MD; James Schaidt, a prostate cancer patient, past board member of ASPI and a current board member of ZERO Prostate Cancer; E. Michael Scott, founder of Prostate Cancer International; Govinda Ramakrishna, a patient on the ASPI board; and Howard Wolinsky, an ASPI co-founder and editor of TheActiveSurveillor.com newsletter.
Find out more about the ASPI Annual Awards on the ASPI website.