As reported in The New England Journal of Medicine by Freddie C. Hamdy, FRCS(Urol), FMedSci, and colleagues, 15-year follow-up of the UK phase III ProtecT trial has shown no significant difference in prostate cancer mortality with active monitoring, surgery, or radiotherapy for patients with localized prostate cancer.
Study Details
In the trial, 1,643 patients with localized prostate cancer were randomly assigned to undergo active monitoring (n = 545), undergo prostatectomy (n = 553), or receive radiotherapy (n = 545). On contemporary risk stratification, 24.1% of patients had intermediate-risk disease and 9.6% had high-risk disease. The primary outcome measure was death from prostate cancer.
Key Findings
Median follow-up was 15 years (range = 11–21 years).
Death from prostate cancer occurred in 45 patients (2.7%) in the entire population, consisting of 17 (3.1%) in the active monitoring group, 12 (2.2%) in the prostatectomy group, and 16 (2.9%) in the radiotherapy group (overall P = .53). At 10- and 15-year follow-up, prostate cancer survival rates were 98.7% and 96.6% in the active-monitoring group, 99.0% and 97.2% in the prostatectomy group, and 99.4% and 97.7% in the radiotherapy group, respectively.
Freddie C. Hamdy, FRCS(Urol), FMedSci
Death from any cause occurred in 356 patients (21.7%) overall, consisting of 124 (22.8%) in the active monitoring group, 117 (21.2%) in the prostatectomy group, and 115 (21.1%) in the radiotherapy group.
Metastases developed in 104 patients (6.3%) overall, consisting of 51 (9.4%) in the active monitoring group, 26 (4.7%) in the prostatectomy group, and in 27 (5.0%) in the radiotherapy group.
Long-term androgen-deprivation therapy was initiated in 151 patients (9.2%) overall, consisting of 69 (12.7%) in the active monitoring group, 40 (7.2%) in the prostatectomy group, and 42 (7.7%) in the radiotherapy group.
Local progression was observed in 259 patients (15.8%) overall, consisting of 141 (25.9%) in the active monitoring group, 58 (10.5%) in the prostatectomy group, and 60 (11.0%) the radiotherapy group.
In the active monitoring group, 133 patients (24.4%) were alive without any prostate cancer treatment at the end of follow-up.
No effects on prostate cancer–specific mortality were observed according to baseline prostate-specific antigen level, tumor stage or grade, or risk-stratification score.
The investigators concluded, “After 15 years of follow-up, prostate cancer–specific mortality was low regardless of the treatment assigned. Thus, the choice of therapy involves weighing trade-offs between benefits and harms associated with treatments for localized prostate cancer.”
Dr. Hamdy, of Nuffield Department of Surgical Sciences, University of Oxford, is the corresponding author for The New England Journal of Medicine article.
Disclosure: The study was funded by the National Institute for Health and Care Research. For full disclosures of the study authors, visit nejm.org.
