Prostate Cancer Intervention Versus Observation Trial (PIVOT)
PIVOT
CSP #407 - Prostate Cancer Intervention Versus Observation Trial (PIVOT): A Randomized Trial Comparing Radical Prostatectomy Versus Palliative Expectant Management for the Treatment of Clinically Localized Prostate Cancer
1 other identifier
interventional
731
1 country
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 prostate-cancer
Started Nov 1994
Longer than P75 for phase_3 prostate-cancer
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 1994
CompletedFirst Submitted
Initial submission to the registry
December 29, 2000
CompletedFirst Posted
Study publicly available on registry
January 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedResults Posted
Study results publicly available
January 10, 2014
CompletedFebruary 24, 2020
February 1, 2020
15.2 years
December 29, 2000
August 15, 2013
February 21, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
All Cause Mortality
Number of deaths from any cause.
From date of randomization until date of death from any cause, assessed until end of study, up to 16 years
Study Arms (2)
Radical Prostatectomy
OTHERSurgical removal of the prostate
Watchful Waiting
NO INTERVENTIONClosely watching, waiting and treating symptoms if and when cancer progresses
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
VA Medical Center, Birmingham
Birmingham, Alabama, 35233, United States
Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
North Little Rock, Arkansas, 72114-1706, United States
VA Medical Center, Long Beach
Long Beach, California, 90822, United States
VA Medical Center, San Francisco
San Francisco, California, 94121, United States
VA Greater Los Angeles HCS, Sepulveda
Sepulveda, California, 91343, United States
James A. Haley Veterans Hospital, Tampa
Tampa, Florida, 33612, United States
VA Medical Center, Boise
Boise, Idaho, 83702, United States
Jesse Brown VAMC (WestSide Division)
Chicago, Illinois, 60612, United States
Richard Roudebush VA Medical Center, Indianapolis
Indianapolis, Indiana, 46202-2884, United States
VA Medical Center, Iowa City
Iowa City, Iowa, 52246-2208, United States
VA Medical Center, Lexington
Lexington, Kentucky, 40502, United States
Overton Brooks VA Medical Center, Shreveport
Shreveport, Louisiana, 71101, United States
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, 48113, United States
Minneapolis VA Health Care System
Minneapolis, Minnesota, 55417, United States
VA New Jersey Health Care System, East Orange
East Orange, New Jersey, 07018, United States
VA Stratton Medical Center, Albany
Albany, New York, 12208, United States
New York Harbor Health Care System, Brooklyn
Brooklyn, New York, 11209, United States
VA Western New York Healthcare System at Buffalo
Buffalo, New York, 14215, United States
VA Medical Center, Syracuse
Syracuse, New York, 13210, United States
VA Medical Center, Bronx
The Bronx, New York, 10468, United States
VA Medical Center, Oklahoma City
Oklahoma City, Oklahoma, 73104, United States
VA Medical Center, Portland
Portland, Oregon, 97201, United States
VA Pittsburgh Health Care System
Pittsburgh, Pennsylvania, 15240, United States
VA Medical Center, Providence
Providence, Rhode Island, 02908, United States
VA Medical Center, Memphis
Memphis, Tennessee, 38104, United States
VA North Texas Health Care System, Dallas
Dallas, Texas, 75216, United States
Central Texas Veterans Health Care System
Temple, Texas, 76504, United States
VA Medical Center, Hampton
Hampton, Virginia, 23667, United States
VA Puget Sound Health Care System, Seattle
Seattle, Washington, 98108, United States
VA Medical Center, Clarksburg
Clarksburg, West Virginia, 26301, United States
Wlliam S. Middleton Memorial Veterans Hospital, Madison
Madison, Wisconsin, 53705, United States
Related Publications (19)
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.
RESULTMoon 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.
PMID: 7577210RESULTWilt 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.
PMID: 7638470RESULTWilt TJ, Brawer MK. The Prostate Cancer Intervention Versus Observation Trial (PIVOT). Oncology (Williston Park). 1997 Aug;11(8):1133-9; discussion 1139-40, 1143.
PMID: 9268976RESULTWilt 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.
RESULTWilt 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.
PMID: 9674725RESULTWilt 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.
PMID: 10866876RESULTWilt 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.
PMID: 10717606RESULTWilt T. Editorial comment. Urology. 2001 Nov 1; 58(6):964-965.
RESULTWilt 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.
PMID: 11828353RESULTWilt 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.
PMID: 18695131RESULTKaplan 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.
PMID: 16406915RESULTWilt 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.
PMID: 22808955RESULTWilt 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.
PMID: 22983306RESULTWilt 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.
PMID: 23271771RESULTBarry 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.
PMID: 23988464RESULTWilt 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.
PMID: 24594482RESULTWilt 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.
PMID: 32089359DERIVEDWilt 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.
PMID: 28700844DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Timothy Wilt, MD
- Organization
- Minneapolis VA Medical Center
Study Officials
- STUDY CHAIR
Timothy J. Wilt, MD MPH
Minneapolis Veterans Affairs Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 29, 2000
First Posted
January 1, 2001
Study Start
November 1, 1994
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
February 24, 2020
Results First Posted
January 10, 2014
Record last verified: 2020-02