Clinical trialNCT00007644CompletedPhase 3Interventional

Prostate Cancer Intervention Versus Observation Trial (PIVOT)

SponsorVA Office of Research and DevelopmentEnrollment731Prostate Cancer

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Radical prostatectomy provides potentially curative removal of the cancer. However, it subjects patients to the morbidity and mortality of the surgery and may be neither necessary nor effective. Expectant management does not offer potential cure. However, it provides palliative therapy for symptomatic or metastatic disease progression, avoids potentially excessive and morbid interventions in asymptomatic patients, and emphasizes management approaches for focus on relieving symptoms while minimizing therapeutic complications. The primary objective of this study is to determine which of two strategies is superior for the management of clinically localized CAP: 1) radical prostatectomy with early aggressive intervention for disease persistence or recurrence, 2) expectant management with reservation of therapy for palliative treatment of symptomatic or metastatic disease progression. Outcomes include total mortality, CAP mortality, disease free and progression free survival, morbidity, quality of life, and cost effectiveness.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Timothy J. Wilt, MD MPH
Minneapolis Veterans Affairs Medical Center
Study Chair
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

31 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Va Medical Center, Birmingham
Birmingham, Alabama, United States
Central Arkansas Vhs Eugene J. Towbin Healthcare Ctr, Little Rock
North Little Rock, Arkansas, United States
Va Medical Center, Long Beach
Long Beach, California, United States
Va Medical Center, San Francisco
San Francisco, California, United States
Va Greater Los Angeles Hcs, Sepulveda
Sepulveda, California, United States
James A. Haley Veterans Hospital, Tampa
Tampa, Florida, United States
Va Medical Center, Boise
Boise, Idaho, United States
Jesse Brown Vamc (westside Division)
Chicago, Illinois, United States
Richard Roudebush Va Medical Center, Indianapolis
Indianapolis, Indiana, United States
Va Medical Center, Iowa City
Iowa City, Iowa, United States
Va Medical Center, Lexington
Lexington, Kentucky, United States
Overton Brooks Va Medical Center, Shreveport
Shreveport, Louisiana, United States
Va Ann Arbor Healthcare System
Ann Arbor, Michigan, United States
Minneapolis Va Health Care System
Minneapolis, Minnesota, United States
Va New Jersey Health Care System, East Orange
East Orange, New Jersey, United States
Va Stratton Medical Center, Albany
Albany, New York, United States
New York Harbor Health Care System, Brooklyn
Brooklyn, New York, United States
Va Western New York Healthcare System at Buffalo
Buffalo, New York, United States
Va Medical Center, Syracuse
Syracuse, New York, United States
Va Medical Center, Bronx
The Bronx, New York, United States
Va Medical Center, Oklahoma City
Oklahoma City, Oklahoma, United States
Va Medical Center, Portland
Portland, Oregon, United States
Va Pittsburgh Health Care System
Pittsburgh, Pennsylvania, United States
Va Medical Center, Providence
Providence, Rhode Island, United States
Va Medical Center, Memphis
Memphis, Tennessee, United States
Va North Texas Health Care System, Dallas
Dallas, Texas, United States
Central Texas Veterans Health Care System
Temple, Texas, United States
Va Medical Center, Hampton
Hampton, Virginia, United States
Va Puget Sound Health Care System, Seattle
Seattle, Washington, United States
Va Medical Center, Clarksburg
Clarksburg, West Virginia, United States
Wlliam S. Middleton Memorial Veterans Hospital, Madison
Madison, Wisconsin, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 30 Nov 1994
Primary completion: 31 Jan 2010
Completion: 31 Jan 2010
Last update posted: 24 Feb 2020
Registered enrollment: 731
Registry id: NCT00007644

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.