Content area
Full Text
We previously reported that radical prostatectomy was not associated with significantly lower all-cause or prostate-cancer mortality than observation with noncurative palliative interventions through 12 years among men with localized prostate cancer detected during the early era of prostate-specific antigen (PSA) testing.1 In light of the protracted disease course and extended survival of many patients, treatment decisions often require information about additional treatments received, patient-reported outcomes, and very-long-term mortality. Three other randomized trials compared radical prostatectomy with observation or PSA-based active monitoring. One older trial showed no significant difference in overall mortality.2 Another trial, also conducted before the widespread use of PSA screening, showed differences favoring surgery in all-cause and prostate-cancer mortality of 12.7 and 11.0 percentage points, respectively, with similar differences in the risk of distant metastases at a median follow-up of 13.4 years.3 The most recent trial, involving men with disease detected by PSA screening, showed no significant difference in all-cause or prostate-cancer mortality after a median of 10 years of follow-up among radiation therapy, surgery, and PSA-based active monitoring and delayed radical intervention.4 We report all-cause and prostate-cancer mortality through nearly 20 years of follow-up and describe disease progression, treatments received, and patient-reported outcomes during the original follow-up.
Methods
Trial Design
We previously described the design, methods, and baseline results of the Prostate Cancer Intervention versus Observation Trial (PIVOT).1,5 The trial was approved by the institutional review board at each site. Patients provided written informed consent. After completion of follow-up through January 2010, we amended the protocol to assess extended all-cause and prostate-cancer mortality. The original and revised protocols, including the statistical analysis plan, are available with the full text of this article at NEJM.org.
Patients
From November 1994 through January 2002, we randomly assigned 731 men with localized prostate cancer (mean age, 67 years; median PSA value, 7.8 ng per milliliter) to radical prostatectomy or observation at Department of Veterans Affairs and National Cancer Institute medical centers.1,5 Patients had to be medically fit for radical prostatectomy and have histologically confirmed, clinically localized prostate cancer (stage T1-T2NxM0 in the tumor–node–metastasis classification system according to the American Joint Committee on Cancer6) of any grade diagnosed within the previous 12 months. Patients had...