GPS-ProtecT study launched to validate Genomic Prostate Score in active surveillance

Mdxhealth and the University of Oxford have initiated a study to validate the Genomic Prostate Score (GPS) in predicting prostate cancer progression and long-term treatment outcomes among patients on active surveillance.¹

The study will leverage the sample and dataset from the landmark ProtecT trial (NCT02044172), the largest randomized clinical trial of treatment effectiveness in patients with localized prostate cancer.

“The ProtecT trial has contributed to shaping international standards for prostate cancer management,” said Freddie C. Hamdy, MBChB, LRCP-LRCSEd, LRCPSGlasg, FRCSEd, FRCSEng, MD (Shef), MA (Oxon) FRCSEd (Urol), FMedSci, of the University of Oxford, in the news release.¹ “By incorporating the Genomic Prostate Score (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).

According to mdxhealth, “The initiation of the GPS-ProtecT study will now leverage one of the most definitive, long-term prostate cancer sample- and data-sets in the world to demonstrate the predictive power of GPS in the context of a mature prospective, randomized trial.”

“This is a transformative moment for prostate cancer precision diagnostics,” said Michael K. McGarrity, CEO of mdxhealth, in the news release.¹ “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.”

About ProtecT

ProtecT is a randomized phase 3 trial that is following more than 1600 men with localized prostate cancer for over 2 decades. Participants in the trial were randomly assigned to receive treatment with either active surveillance/active monitoring, radical prostatectomy, or radiotherapy in order to assess long-term treatment outcomes.

Fifteen-year data from the trial were published in The New England Journal of Medicine in March 2023,² showing low prostate cancer-specific mortality (PCSM) rates across all 3 treatment groups. Specifically, 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). According to the authors, this finding suggests the need to carefully consider the benefits and harms of each treatment option when making decisions on choice of therapy.

Final completion of the ProtecT trial is expected in March 2027.³

REFERENCES

1. Mdxhealth and University of Oxford to validate GPS test in largest randomized trial of treatment effectiveness in patients with localized prostate cancer. News release. Mdxhealth. January 6, 2026. Accessed January 6, 2026. https://mdxhealth.com/press_release/mdxhealth-and-university-of-oxford-to-validate-gps-test-in-largest-randomized-trial-of-treatment-effectiveness-in-patients-with-localized-prostate-cancer/

2. Hamdy FC, Donovan JL, Lane JA, et al. Fifteen-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer. N Engl J Med. 2023;388(17):1547-1558. doi:10.1056/NEJMoa2214122

3. Prostate Testing for Cancer and Treatment (ProtecT). ClinicalTrials.gov. November 14, 2022. Accessed January 6, 2026. https://clinicaltrials.gov/study/NCT02044172