BackgroundThe comparative effectiveness of treatments for PSA-detected prostate cancer remains uncertain. The Prostate testing for cancer and Treatment (ProtecT) trial compared active monitoring, radical prostatectomy and external-beam radiotherapy treatment strategies for clinically localized disease.MethodsBetween 1999 and 2009, 82,429 men aged 50-69 years received a PSA test, 2,664 were diagnosed with localized prostate cancer and 1,643 agreed to randomization to active monitoring (n=545), radical prostatectomy (n=553) or radiotherapy (n=545). The primary end-point was prostate cancer mortality at 10-year median follow-up. Secondary outcomes included disease progression,metastases, and all-cause mortality.ResultsThere were no differences between the arms for 17 prostate cancer-specific (p=0.48) and 169 allcause (p=0.87) deaths. Eight men died of prostate cancer in the active monitoring arm (1.5 per-1000- person-years [p1000pyrs], 95% confidence interval [CI]: 0.7-3.0); 5 in the surgery arm (0.9 p1000pyrs; 95% CI: 0.4-2.2), and 4 in the radiotherapy arm (0.7 p1000pyrs; 95% CI: 0.3-2.0). Moremen developed metastases in the active monitoring arm (n=33; 6.3 p1000pyrs; 95% CI: 4.5-8.8), compared with surgery (n=13; 2.4 p1000pyrs; 1.4-4.2) and radiotherapy (n=16; 3.0 p1000pyrs; 95% CI: 1.9-4.9); p=0.004. Higher rates of disease progression occurred in the active monitoring arm (n=112; 22.9 p1000pyrs; 95% CI: 19.0-27.5) compared with surgery (n=46; 8.9 p1000pyrs; 95% CI: 6.7-11.9) and radiotherapy (n=46; 9.0 p1000pyrs; 95% CI: 6.7-12.0); p<0.001.ConclusionsAt a median of 10-years, prostate cancer-specific mortality was low irrespective of treatment assigned. Surgery and radiotherapy reduced disease progression and metastases. Further follow-up is required to ascertain if this confers long-term survival benefits.
- BTC (Bristol Trials Centre)
- Centre for Surgical Research