A Randomized Trial Comparing Radical Prostatectomy with Watchful Waiting in Early Prostate Cancer

• Published in: The New England journal of medicine Vol. 347; no. 11; pp. 781 - 789
• Main Authors: Holmberg, Lars, Bill-Axelson, Anna, Helgesen, Fred, Salo, Jaakko O, Folmerz, Per, Häggman, Michael, Andersson, Swen-Olof, Spångberg, Anders, Busch, Christer, Nordling, Steg, Palmgren, Juni, Adami, Hans-Olov, Johansson, Jan-Erik, Norlén, Bo Johan
• Format: Journal Article
• Language: English
• Published: Boston, MA Massachusetts Medical Society 12.09.2002
• Subjects: Aged; Biological and medical sciences; Clinical trials; Disease Progression; Follow-Up Studies; Humans; Male; Medical procedures; Medical sciences; MEDICIN; Medicin och hälsovetenskap; MEDICINE; Middle Aged; Mortality; Neoplasm Metastasis; Neoplasm Recurrence, Local; Nephrology. Urinary tract diseases; Prevention; Proportional Hazards Models; Prostate cancer; Prostatectomy; Prostatic Neoplasms - mortality; Prostatic Neoplasms - surgery; Prostatic Neoplasms - therapy; Survival Analysis; Tumors of the urinary system; Urinary tract. Prostate gland; Human; Urinary system disease; Prognosis; Prostate disease; Mortality; Male; Early stage; Malignant tumor; Surveillance; Surgery; Prostatectomy; Male genital diseases; Prostate; Comparative study
• ISSN: 0028-4793; 1533-4406; 1533-4406
• DOI: 10.1056/NEJMoa012794

A total of 695 men with early prostate cancer were randomly assigned to radical prostatectomy or watchful waiting. After a median follow-up of more than six years, more deaths due to prostate cancer had occurred in the watchful-waiting group, but overall survival in the two groups was essentially the same. Men with early prostate cancer were assigned to radical prostatectomy or watchful waiting. Survival in the two groups was similar. The management of early prostate cancer is controversial. Radical prostatectomy has become widely used, but its possible benefit has not been adequately documented in a randomized trial. Early studies indicated a lower rate of progression after surgery than after external radiotherapy, 1 but no gain in overall survival after more than 20 years of follow-up, as compared with primary expectant management (watchful waiting). 2 , 3 Systematic overviews of observational studies reveal a lack of reliable data to support any specific recommendation for the treatment of early prostate cancer. 4 – 7 We conducted a randomized trial in 695 men with early prostate cancer, who . . .