Prostate Cancer Intervention Versus Observation Trial (PIVOT)
NCT ID: NCT00007644
Last Updated: 2020-02-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
731 participants
INTERVENTIONAL
1994-11-30
2010-01-31
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Radical Prostatectomy
Surgical removal of the prostate
Radical prostatectomy
Surgical removal of the prostate
Watchful Waiting
Closely watching, waiting and treating symptoms if and when cancer progresses
No interventions assigned to this group
Interventions
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Radical prostatectomy
Surgical removal of the prostate
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of Prostate Cancer within previous 6 months
* Age 75 years or younger
Exclusion Criteria
75 Years
MALE
No
Sponsors
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Agency for Healthcare Research and Quality (AHRQ)
FED
National Cancer Institute (NCI)
NIH
VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Timothy J. Wilt, MD MPH
Role: STUDY_CHAIR
Minneapolis Veterans Affairs Medical Center
Locations
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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
Countries
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References
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Wilt T. Expectant management or early intervention for clinically localized prostate cancer? What we need are randomized trials. Clinical Care For Prostatic Diseases. 1994 Jan 6; 1:1-9.
Moon TD, Brawer MK, Wilt TJ. Prostate Intervention Versus Observation Trial (PIVOT): a randomized trial comparing radical prostatectomy with palliative expectant management for treatment of clinically localized prostate cancer. PIVOT Planning Committee. J Natl Cancer Inst Monogr. 1995;(19):69-71. No abstract available.
Wilt TJ, Brawer MK. Early intervention or expectant management for prostate cancer. The Prostate Cancer Intervention Versus Observation Trial (PIVOT): a randomized trial comparing radical prostatectomy with expectant management for the treatment of clinically localized prostate cancer. Semin Urol. 1995 May;13(2):130-6. No abstract available.
Wilt TJ, Brawer MK. The Prostate Cancer Intervention Versus Observation Trial (PIVOT). Oncology (Williston Park). 1997 Aug;11(8):1133-9; discussion 1139-40, 1143.
Wilt T. The importance of randomized treatment trials in early stage prostate cancer. New Developments in Prostate Cancer and Treatment. 1997 Feb 21; 2:29-35.
Wilt TJ. Prostate cancer screening: practice what the evidence preaches. Am J Med. 1998 Jun;104(6):602-4. doi: 10.1016/s0002-9343(98)00127-2. No abstract available.
Wilt TJ. Uncertainty in prostate cancer care: the physician's role in clearing the confusion. JAMA. 2000 Jun 28;283(24):3258-60. doi: 10.1001/jama.283.24.3258. No abstract available.
Wilt TJ. Prostate carcinoma practice patterns: what do they tell us about the diagnosis, treatment, and outcomes of patients with prostate carcinoma? Cancer. 2000 Mar 15;88(6):1277-81. No abstract available.
Wilt T. Editorial comment. Urology. 2001 Nov 1; 58(6):964-965.
Wilt TJ. Clarifying uncertainty regarding detection and treatment of early-stage prostate cancer. Semin Urol Oncol. 2002 Feb;20(1):10-7. doi: 10.1053/suro.2002.30393.
Wilt TJ. SPCG-4: a needed START to PIVOTal data to promote and protect evidence-based prostate cancer care. J Natl Cancer Inst. 2008 Aug 20;100(16):1123-5. doi: 10.1093/jnci/djn259. Epub 2008 Aug 11. No abstract available.
Kaplan SA, McConnell JD, Roehrborn CG, Meehan AG, Lee MW, Noble WR, Kusek JW, Nyberg LM Jr; Medical Therapy of Prostatic Symptoms (MTOPS) Research Group. Combination therapy with doxazosin and finasteride for benign prostatic hyperplasia in patients with lower urinary tract symptoms and a baseline total prostate volume of 25 ml or greater. J Urol. 2006 Jan;175(1):217-20; discussion 220-1. doi: 10.1016/S0022-5347(05)00041-8.
Wilt TJ, Brawer MK, Jones KM, Barry MJ, Aronson WJ, Fox S, Gingrich JR, Wei JT, Gilhooly P, Grob BM, Nsouli I, Iyer P, Cartagena R, Snider G, Roehrborn C, Sharifi R, Blank W, Pandya P, Andriole GL, Culkin D, Wheeler T; Prostate Cancer Intervention versus Observation Trial (PIVOT) Study Group. Radical prostatectomy versus observation for localized prostate cancer. N Engl J Med. 2012 Jul 19;367(3):203-13. doi: 10.1056/NEJMoa1113162.
Wilt TJ. Implications of the prostate intervention versus observation trial (PIVOT). Asian J Androl. 2012 Nov;14(6):815. doi: 10.1038/aja.2012.103. Epub 2012 Sep 17. No abstract available.
Wilt TJ. The Prostate Cancer Intervention Versus Observation Trial: VA/NCI/AHRQ Cooperative Studies Program #407 (PIVOT): design and baseline results of a randomized controlled trial comparing radical prostatectomy with watchful waiting for men with clinically localized prostate cancer. J Natl Cancer Inst Monogr. 2012 Dec;2012(45):184-90. doi: 10.1093/jncimonographs/lgs041.
Barry MJ, Andriole GL, Culkin DJ, Fox SH, Jones KM, Carlyle MH, Wilt TJ. Ascertaining cause of death among men in the prostate cancer intervention versus observation trial. Clin Trials. 2013;10(6):907-14. doi: 10.1177/1740774513498008. Epub 2013 Aug 29.
Wilt TJ, Scardino PT, Carlsson SV, Basch E. Prostate-specific antigen screening in prostate cancer: perspectives on the evidence. J Natl Cancer Inst. 2014 Mar;106(3):dju010. doi: 10.1093/jnci/dju010. Epub 2014 Mar 4. No abstract available.
Wilt TJ, Vo TN, Langsetmo L, Dahm P, Wheeler T, Aronson WJ, Cooperberg MR, Taylor BC, Brawer MK. Radical Prostatectomy or Observation for Clinically Localized Prostate Cancer: Extended Follow-up of the Prostate Cancer Intervention Versus Observation Trial (PIVOT). Eur Urol. 2020 Jun;77(6):713-724. doi: 10.1016/j.eururo.2020.02.009. Epub 2020 Feb 21.
Wilt TJ, Jones KM, Barry MJ, Andriole GL, Culkin D, Wheeler T, Aronson WJ, Brawer MK. Follow-up of Prostatectomy versus Observation for Early Prostate Cancer. N Engl J Med. 2017 Jul 13;377(2):132-142. doi: 10.1056/NEJMoa1615869.
Other Identifiers
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407
Identifier Type: -
Identifier Source: org_study_id
NCT00002606
Identifier Type: -
Identifier Source: nct_alias
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