ProtecT trial shows classical risk categories don’t help
The classical risk categories used to stage prostate cancer disease do not aid clinical decision-making as much as PSA, biopsy, Gleason score, biopsy results and other measurements, according to an expert who commented during the Late-Breaking news segment of Plenary Session 6 at the 32nd Annual EAU Congress (EAU17).
“What do we learn from the ProtecT trial? Classical risk categories don’t help. What aids decision-making are PSA, biopsy and Gleason scores, number of cores, and the maximum and total cancer length,” said Prof. Christian Stief (DE) who gave commentary following the report from Mr. Richard Bryant (GB) regarding the ProtecT trial.
ProtecT, which aims to evaluate the effectiveness, cost-effectiveness and acceptability of treatments for men with localised prostate cancer, was a randomised controlled trial which ran from 1999 to 2009 and which screened around 82,429 men for PSA. A total of 2,664 men were found to have prostate cancer, with 1,643 randomised to active surveillance, radical prostatectomy or radiation therapy.
In his report, Bryant said there was no difference in prostate-specific or all-cause mortality at 10-year median follow-up. Radical treatments halved the incidence of metastases and clinical progressions compared to active monitoring (AM), and were equally effective.
“All conventional baseline clinic-pathological features (PSA, cT stage, biopsy Gleason sum score, number of involved cores, etc.) at initial biopsy showed significant differences with regard to disease progression status,” said Bryant. “A spectrum of disease progression (PCa-specific death, metastasis development, and need for further treatment) was observed.”
Bryant added that contemporary risk categories based on PSA, Gleason score and clinical stage “…appear insufficient to reliably predict progression in individuals with clinically localized PSA-detected PCa after a median 10 years of follow-up.”
In his concluding remarks on how the ProtecT study can inform clinical practice, Stief said: “Active surveillance (AS) is appropriate for low-risk patients. A subset of patients on AS will get therapy but will have worse outcomes compared to those who received immediate therapy.”