Prostate Cancer Intervention Versus Observation Trial (PIVOT)
- Conditions
- Prostate Cancer
- Interventions
- Procedure: Radical prostatectomy
- Registration Number
- NCT00007644
- Lead Sponsor
- VA Office of Research and Development
- Brief Summary
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.
- Detailed Description
Primary Hypothesis: To determine whether radical prostatectomy or expectant management is more effective in reducing mortality and extending life.
Secondary Hypothesis: To determine which treatment strategy is superior in terms of prostate specific cancer mortality, quality of life, occurrence or recurrence of symptoms and need for cancer treatment.
Intervention: 1) Radical prostatectomy, plus intervention for evidence of disease persistence or recurrence, 2) Expectant management with palliative therapy reserved for symptomatic or metastatic disease progression.
Primary Outcomes: All cause mortality.
Study Abstract: Cancer of the prostate (CAP) is the most common nondermatologic and the second most frequent cause of cancer deaths in men. No cure is currently possible for disseminated disease. Cancer confined to the prostate is believed to be curable, with the most frequently recommended therapy being surgical extirpation of the tumor with radical prostatectomy. However, despite increasing cancer detection and aggressive surgical treatment, population-based mortality rates from prostate cancer have not decreased, neither nationally nor in states with high rates of radical prostatectomy. Existing evidence does not demonstrate the superiority of this procedure compared to expectant management in the treatment of localized prostate cancer. Data from case series suggest that either treatment approach provides equivalent all-cause as well as prostate cancer specific mortality. The only randomized trial was limited by a small sample size but the results favored expectant management.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 731
- Patients with clinically localized CAP
- Diagnosis of Prostate Cancer within previous 6 months
- Age 75 years or younger
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Radical Prostatectomy Radical prostatectomy Surgical removal of the prostate
- Primary Outcome Measures
Name Time Method All Cause Mortality From date of randomization until date of death from any cause, assessed until end of study, up to 16 years Number of deaths from any cause.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (31)
VA Medical Center, Iowa City
🇺🇸Iowa City, Iowa, United States
VA New Jersey Health Care System, East Orange
🇺🇸East Orange, New Jersey, United States
VA Puget Sound Health Care System, Seattle
🇺🇸Seattle, Washington, United States
VA Greater Los Angeles HCS, Sepulveda
🇺🇸Sepulveda, California, United States
VA Medical Center, Long Beach
🇺🇸Long Beach, California, United States
Jesse Brown VAMC (WestSide Division)
🇺🇸Chicago, Illinois, United States
Richard Roudebush VA Medical Center, Indianapolis
🇺🇸Indianapolis, Indiana, 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 Pittsburgh Health Care System
🇺🇸Pittsburgh, Pennsylvania, United States
VA Medical Center, Providence
🇺🇸Providence, Rhode Island, 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 Medical Center, Birmingham
🇺🇸Birmingham, Alabama, United States
VA Medical Center, San Francisco
🇺🇸San Francisco, California, United States
Minneapolis VA Health Care System
🇺🇸Minneapolis, Minnesota, United States
VA Medical Center, Oklahoma City
🇺🇸Oklahoma City, Oklahoma, United States
VA Medical Center, Portland
🇺🇸Portland, Oregon, United States
James A. Haley Veterans Hospital, Tampa
🇺🇸Tampa, Florida, United States
VA Medical Center, Boise
🇺🇸Boise, Idaho, United States
VA Medical Center, Clarksburg
🇺🇸Clarksburg, West Virginia, United States
Overton Brooks VA Medical Center, Shreveport
🇺🇸Shreveport, Louisiana, United States
Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
🇺🇸North Little Rock, Arkansas, United States
VA Medical Center, Memphis
🇺🇸Memphis, Tennessee, United States
VA Medical Center, Lexington
🇺🇸Lexington, Kentucky, United States
VA Ann Arbor Healthcare System
🇺🇸Ann Arbor, Michigan, United States
VA Medical Center, Bronx
🇺🇸Bronx, New York, United States
Wlliam S. Middleton Memorial Veterans Hospital, Madison
🇺🇸Madison, Wisconsin, United States