Prostate Cancer Intervention Versus Observation Trial (PIVOT)
Completed · Phase 3
Conditions studied: Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT00007644
- Run by
- VA Office of Research and Development
- People needed
- 731
- Starts
- 1994-11-01
- Expected to finish
- 2010-01-01
- Last updated by the study team
- 2020-02-24
Who can join
Age: any, up to 75. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Patients with clinically localized CAP
- Diagnosis of Prostate Cancer within previous 6 months
- Age 75 years or younger
You may not qualify if…
- PSA > 50 ng/ml Bone scan consistent with metastatic disease Other evidence that cancer of the prostate is not clinically localized Diagnosis of prostate cancer greater than 12 months ago Life expectancy less than 10 years Serum creatinine greater than 3 mg/dl Myocardial infarction within last 6 months Unstable angina New York Heart Association Class III or IV congestive heart failure Severe pulmonary disease Lifer failure Severe dementia Debilitating illness Malignancies, except for nonmelanomatous skin cancer, in the last 5 years
Where it is running
- 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
Full record on ClinicalTrials.gov
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