Mdxhealth Partners with Oxford to Validate Genomic Prostate Score in Landmark ProtecT Trial
核心洞察
Mdxhealth and the University of Oxford have launched the GPS-ProtecT study to validate the Genomic Prostate Score (搜索) test in predicting prostate cancer progression among patients on active surveillance.
The validation will leverage samples and data from the ProtecT trial, the world's largest randomized clinical trial of treatment effectiveness in localized prostate cancer, following over 1,500 men for more than two decades.
The study aims to establish GPS as the first genomic classifier supported by randomized clinical trial evidence in an active surveillance cohort, potentially redefining risk evaluation and personalized care for prostate cancer patients.
Mdxhealth and the University of Oxford have initiated the GPS-ProtecT study to validate the Genomic Prostate Score (搜索) (GPS) test in predicting prostate cancer progression and long-term treatment outcomes among patients on active surveillance. The collaboration represents a significant step toward establishing GPS as the first genomic classifier supported by randomized clinical trial evidence in an active surveillance cohort.
The study will leverage samples and datasets from the landmark ProtecT trial (NCT02044172), widely regarded as the world's largest randomized clinical trial of treatment effectiveness in patients with localized prostate cancer. The ProtecT trial has been following more than 1,500 men with localized disease for over two decades, providing unmatched long-term clinical outcome data across active surveillance/active monitoring, radical prostatectomy, and radiotherapy.
Building on Established Clinical Evidence
"The ProtecT trial has contributed to shaping international standards for prostate cancer management," said Professor Freddie C. Hamdy of the University of Oxford. "By incorporating the Genomic Prostate Score (搜索) (GPS) test, we are building on decades of outcomes data with genomic insights that could redefine how physicians evaluate risk and personalize care for patients worldwide."
The GPS test was previously validated in predicting prostate cancer progression using samples from the ProMPT cohort (NCT00967889). This new study builds on the partnership announced in September 2023, in which Mdxhealth and Oxford began evaluating the correlation between GPS and prostate cancer progression using samples from the well-annotated ProMPT cohort.
Landmark Trial Data Shows Low Mortality Rates
Fifteen-year data from the ProtecT trial, published in The New England Journal of Medicine in March 2023, demonstrated low prostate cancer-specific mortality (PCSM) rates across all three treatment groups. The PCSM rate was 3.1% in the active monitoring cohort, 2.2% in the prostatectomy cohort, and 2.9% in the radiotherapy cohort (P = .53 for the overall comparison). These findings suggest the need to carefully consider the benefits and harms of each treatment option when making therapy decisions.
Clinical Impact and Future Implications
"This is a transformative moment for prostate cancer precision diagnostics," said Michael K. McGarrity, CEO of Mdxhealth. "No other patient cohort combines this level of rigor, long-term follow-up, and potential impact on clinical practice guidelines, payer coverage, and provider adoption for patients diagnosed with localized prostate cancer."
The ProtecT trial is a randomized phase 3 study that randomly assigned participants to receive treatment with either active surveillance/active monitoring, radical prostatectomy, or radiotherapy to assess long-term treatment outcomes. Final completion of the ProtecT trial is expected in March 2027.
According to Mdxhealth, the initiation of the GPS-ProtecT study will leverage one of the most definitive, long-term prostate cancer sample and datasets in the world to demonstrate the predictive power of GPS in the context of a mature prospective, randomized trial.