Men with clinically detected, localized prostate cancer and long life expectancies gained an average of 2.9 years of life after undergoing radical prostatectomy, according to a randomized study published in The New England Journal of Medicine.
Researchers also found that high Gleason scores and the presence of extracapsular extension in the radical prostatectomy specimens were highly predictive of death of prostate cancer.
“Radical prostatectomy reduces mortality among men with clinically detected localized prostate cancer, but evidence from randomized trials with long-term follow up is sparse,” Anna Bill-Axelson, MD, PhD, of the department of surgical sciences at Uppsala University, and colleagues wrote. “The strengths of our trial are the randomized design, the completeness of the long-term follow-up data, and the blinded evaluation of causes of death.”
Researchers randomly assigned 695 men with localized prostate cancer — all of whom were aged younger than 75 years, had a life expectancy of at least 10 years, and had no other known cancer that could shorten survival — to watchful waiting (n = 348; median age, 64.5 years) or a radical prostatectomy (n = 347; median age, 64.6 years) between 1989 and 1999. All men had PSA levels lower than 50 ng/mL.
Death of any cause, death of prostate cancer and metastasis served as study endpoints.
Researchers collected follow-up data through 2017; median follow-up was 23.6 years.
During follow-up, 261 men in the radical prostatectomy group died, with 71 of them dying of prostate cancer. A total of 292 men from the watchful waiting group died, 110 of whom died of prostate cancer.
The cumulative incidence of death at 23 years was 71.9% in the radical prostatectomy group and 83.8% in the watchful waiting group (difference, 12 percentage points; 95% CI, 5.5-18.4).
The cumulative incidence of death of prostate cancer after 23 years was 19.6% in the radical prostatectomy group and 31.3% in the watchful waiting group (RR = 0.55; 95% CI, 0.41-0.71; difference, 11.7 percentage points; 95% CI, 5.2-18.2).
Overall, the radical prostatectomy group gained a mean 2.9 years of life at 23 years compared with the watchful waiting group.
Ninety-two men in the radical prostatectomy group and 150 men in the watchful waiting group developed distant metastasis, for a cumulative incidence at 23 years of 26.6% in the radical prostatectomy group and 43.3% in the watchful waiting group (RR = 0.54; 95% CI, 0.42-0.7; difference, 16.7 percentage points; 95% CI, 9.6-23.7).
Researchers noted that diagnostic procedures used at the beginning of the trial are now outdated, which may serve as a limitation to these findings.
“Today, men undergo multiple biopsies or multiparametric MRI with targeted biopsies, whereas the participants in our trial had only cytologic or sextant biopsies, with few cores investigated as compared with current standards,” Bill-Axelson and colleagues wrote. “Today, the clinical domain of localized prostate cancer is different, and the sensitivity for the detection of high-grade cancers during our trial was considerably lower than it is today.”– by John DeRosier
Disclosures : The Swedish Cancer Society funded this study. Bill-Axelson reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.