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VA Cooperative Studies Program (CSP)

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CSP #407: Prostate Cancer Intervention Versus Observation Trial (PIVOT)


Investigator Access

What's Available

Check with the study contact and publications for information on a public dataset, data archive, data enclave, or website where data might be available.

Available Documentation

Dates Data are Available

Access Criteria

Study Characteristics


The primary objective of this study is to determine which of two strategies is superior for the management of clinically localized prostate cancer

  • Radical prostatectomy with early aggressive intervention for disease persistence or recurrence
  • Expectant management with reservation of therapy for palliative treatment of symptomatic or metastatic disease progression

Era of Service



Male patients diagnosed with or treated for early-stage (I/II) prostate cancer within the Department of Veterans Affairs (VA) health care system.

Study Design

Randomized controlled clinical trial


  • Intervention: Radical prostatectomy (surgical removal of the prostate)
  • No intervention: Expectant management (closely watching, waiting, and treating symptoms if cancer progresses)

Time Period

November 1994 – January 2010




731 (expectant management n=367, radical prostatectomy n =364)

Response Rate

All-cause Mortality (as of 1/31/10):

  • Expectant Management:  183 deaths in 367 randomized (49.9%)
  • Radical Prostatectomy: 171 deaths in 364 randomized (47.0%)

Recruitment Method

13,022 men with prostate cancer were screened at 44 VA and 8 National Cancer Institute sites for potential enrollment. 5,023 met initial age, comorbidity, and disease eligibility criteria, and a total of 731 men agreed to participate and were randomized.



Data Collected

Primary outcome

  • All-cause mortality                 

Secondary outcome

  • Prostate-cancer mortality                                

Additional outcomes

  • Bone metastases     
  • Systemic progression   
  • General and disease-specific quality of life   
  • Harms of therapy including 30-day perioperative mortality and morbidity and longer-term urinary, bowel, and erectile dysfunction            

Data Collection Methods

  • Questionnaires and physical exams administered at in-person study visits
  • Self-administered survey questionnaires
  • Medical records
  • Laboratory reports

Funding Sources

  • VA Cooperative Studies Program (CSP)
  • Department of Health and Human Services (HHS)
               o Agency for Healthcare Research and Quality (AHRQ)
               o National Institutes of Health – National Cancer Institute (NCI)


Principal Investigator: Timothy J. Wilt, MD, MPH
Study Chairs: Timothy J. Wilt, MD, MPH and Michael K. Brawer, MD


Annette Wiseman, Project Manager, Perry Point CSPCC,

Selected Publications

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.

Wilt TJ, Brawer MK, Barry MJ, Jones KM, Kwon Y, Gingrich JR, Aronson WJ, Nsouli I, Iyer P, Cartagena R, Snider G, Roehrborn C, Fox S. 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 to watchful waiting for men with clinically localized prostate cancer.  Contemporary Clinical Trials. 2009 Jan;30(1):81-7. Epub 2008 Aug 23.

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. PMID: 28700844

More Information

Study site Identifier: NCT00007644