Bill-Axelson A, Holmberg L, Garmo H, et al. Radical Prostatectomy or Watchful Waiting in Prostate Cancer - 29-Year Follow-up. N Engl J Med. 2018 Dec 13;379(24):2319-2329. doi: 10.1056/NEJMoa1807801.
Abstract

BACKGROUND: Radical prostatectomy reduces mortality among men with clinically detected localized prostate cancer, but evidence from randomized trials with long-term follow-up is sparse.

METHODS: We randomly assigned 695 men with localized prostate cancer to watchful waiting or radical prostatectomy from October 1989 through February 1999 and collected follow-up data through 2017. Cumulative incidence and relative risks with 95% confidence intervals for death from any cause, death from prostate cancer, and metastasis were estimated in intention-to-treat and per-protocol analyses, and numbers of years of life gained were estimated. We evaluated the prognostic value of histopathological measures with a Cox proportional-hazards model.

RESULTS: By December 31, 2017, a total of 261 of the 347 men in the radical-prostatectomy group and 292 of the 348 men in the watchful-waiting group had died; 71 deaths in the radical-prostatectomy group and 110 in the watchful-waiting group were due to prostate cancer (relative risk, 0.55; 95% confidence interval [CI], 0.41 to 0.74; P<0.001; absolute difference in risk, 11.7 percentage points; 95% CI, 5.2 to 18.2). The number needed to treat to avert one death from any cause was 8.4. At 23 years, a mean of 2.9 extra years of life were gained with radical prostatectomy. Among the men who underwent radical prostatectomy, extracapsular extension was associated with a risk of death from prostate cancer that was 5 times as high as that among men without extracapsular extension, and a Gleason score higher than 7 was associated with a risk that was 10 times as high as that with a score of 6 or lower (scores range from 2 to 10, with higher scores indicating more aggressive cancer).

CONCLUSIONS: Men with clinically detected, localized prostate cancer and a long life expectancy benefited from radical prostatectomy, with a mean of 2.9 years of life gained. A high Gleason score and the presence of extracapsular extension in the radical prostatectomy specimens were highly predictive of death from prostate cancer. (Funded by the Swedish Cancer Society and others.).

Ratings by Clinicians (at least 3 per Specialty)
Specialty Score
Surgery - Urology
Oncology - Genitourinary
Internal Medicine
Family Medicine (FM)/General Practice (GP)
General Internal Medicine-Primary Care(US)
Surgery - Oncology
Comments from MORE raters

General Internal Medicine-Primary Care(US) rater

This study puts more wrinkles in the prostate cancer study. The choice to use watchful waiting versus radical prostatectomy is a nuanced decision and has to take frailty in context.

General Internal Medicine-Primary Care(US) rater

As an Internist, I have never been able to sort out what to do with in this situation. Although not at all my area of expertise, I can say if you are a relatively healthy male with a certain burden of disease and invasion, you would or would not benefit from a radical prostatectomy. Disclaimer - not my area of expertise.

Internal Medicine rater

Good information to have especially when patients need advice about whether to undergo the radical prostatectomy or participate in watchful waiting.

Internal Medicine rater

This long-term RCT data are really useful. It would have been nice to see whether there are subgroups who wouldn`t benefit from surgery, but there may not have been sufficient participants.

Oncology - Genitourinary rater

This article demonstrates improved survival with radical prostatectomy vs watchful waiting in long-term follow-up. While this trial certainly supports the practice of radical prostatectomy, I would caution applying the results to all patients. Patients with low Gleason score and no other aggressive features may not benefit as much as those with more aggressive disease. It is important to try to select patients well to maximize benefit and minimize harm.

Surgery - Oncology rater

Interesting paper. For me as a surgical oncologist, it has the value of long term followup in a frequent type of cancer.

Surgery - Oncology rater

Further guidance in a complicated decision pathway.

Surgery - Urology rater

Excellent methodology. It is not clear what is meant by moderately differentiated Prostate cancer in the inclusion criteria. The authors should have defined it better.