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

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ClinicalTrials.gov Identifier: NCT00007644
Recruitment Status : Completed
First Posted : January 1, 2001
Results First Posted : January 10, 2014
Last Update Posted : May 9, 2014
Sponsor:
Collaborators:
Agency for Healthcare Research and Quality (AHRQ)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

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
Enrollment 731
Recruitment Details 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 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.
Arm/Group Title Radical Prostatectomy Watchful Waiting
Hide Arm/Group Description Surgical removal of the prostate Closely watching, waiting and treating symptoms if and when cancer progresses
Period Title: Overall Study
Started 364 367
Completed 364 367
Not Completed 0 0
Arm/Group Title Radical Prostatectomy Watchful Waiting Total
Hide Arm/Group Description Surgical removal of the prostate Closely watching, waiting and treating symptoms if and when cancer progresses Total of all reporting groups
Overall Number of Baseline Participants 364 367 731
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 364 participants 367 participants 731 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
122
  33.5%
131
  35.7%
253
  34.6%
>=65 years
242
  66.5%
236
  64.3%
478
  65.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 364 participants 367 participants 731 participants
67.0  (5.2) 66.8  (5.6) 66.9  (5.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 364 participants 367 participants 731 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
364
 100.0%
367
 100.0%
731
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 364 participants 367 participants 731 participants
364 367 731
1.Primary Outcome
Title All Cause Mortality
Hide Description Annually, from date of randomization until the date of death from any cause, assessed up to 8 years.
Time Frame Annual
Outcome Measure Data Not Reported
2.Primary Outcome
Title All Cause Mortality
Hide Description Bi-annually, from date of randomization until the date of death from any cause, assessed up to 8 years.
Time Frame bi-annual
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Radical Prostatectomy Watchful Waiting
Hide Arm/Group Description:
Surgical removal of the prostate
Closely watching, waiting and treating symptoms if and when cancer progresses
Overall Number of Participants Analyzed 364 367
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
47.0
(41.9 to 52.1)
49.9
(44.8 to 55.0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Radical Prostatectomy Watchful Waiting
Hide Arm/Group Description Surgical removal of the prostate Closely watching, waiting and treating symptoms if and when cancer progresses
All-Cause Mortality
Radical Prostatectomy Watchful Waiting
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Radical Prostatectomy Watchful Waiting
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   171/364 (46.98%)      183/367 (49.86%)    
General disorders     
Death  171/364 (46.98%)  171 183/367 (49.86%)  183
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Radical Prostatectomy Watchful Waiting
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/364 (0.00%)      0/367 (0.00%)    
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.
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov 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