Prostate Cancer Intervention Versus Observation Trial (PIVOT) (PIVOT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00007644
Recruitment Status : Completed
First Posted : January 1, 2001
Results First Posted : January 10, 2014
Last Update Posted : May 9, 2014
Agency for Healthcare Research and Quality (AHRQ)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Prostate Cancer
Intervention: Procedure: Radical prostatectomy

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment begain in November 1994 and ended in January 2002 with follow-up through January 2010. We recruited men from 44 Department of Veterans Affairs sites and 8 National Cancer Institute sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 13,022 men were entered into study logs as potentially eligible. Based upon further chart review, 6707 met age, comorbidity and prostate cancer specific criteria and received detailed information about the study. From these, 5023 were considered likely to be eligible and a total of 731 men agreed to participate.

Reporting Groups
Radical Prostatectomy Surgical removal of the prostate
Watchful Waiting Closely watching, waiting and treating symptoms if and when cancer progresses

Participant Flow:   Overall Study
    Radical Prostatectomy   Watchful Waiting
STARTED   364   367 
COMPLETED   364   367 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Radical Prostatectomy Surgical removal of the prostate
Watchful Waiting Closely watching, waiting and treating symptoms if and when cancer progresses
Total Total of all reporting groups

Baseline Measures
   Radical Prostatectomy   Watchful Waiting   Total 
Overall Participants Analyzed 
[Units: Participants]
 364   367   731 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   122   131   253 
>=65 years   242   236   478 
[Units: Years]
Mean (Standard Deviation)
 67.0  (5.2)   66.8  (5.6)   66.9  (5.4) 
[Units: Participants]
Female   0   0   0 
Male   364   367   731 
Region of Enrollment 
[Units: Participants]
United States   364   367   731 

  Outcome Measures

1.  Primary:   All Cause Mortality   [ Time Frame: bi-annual ]

2.  Primary:   All Cause Mortality   [ Time Frame: Annual ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Timothy Wilt, MD
Organization: Minneapolis VA Medical Center
phone: 612-467-2158

Publications of Results:
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.
Wilt T, Brawer M. The Prostate Cancer Intervention versus Observation Trial. Cancer. 1995 May 12; 75:1963-1968.
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 T. Editorial comment. Urology. 2001 Nov 1; 58(6):964-965.

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: VA Office of Research and Development Identifier: NCT00007644     History of Changes
Obsolete Identifiers: NCT00002606
Other Study ID Numbers: 407
First Submitted: December 29, 2000
First Posted: January 1, 2001
Results First Submitted: August 15, 2013
Results First Posted: January 10, 2014
Last Update Posted: May 9, 2014