Prostate Cancer Intervention Versus Observation Trial (PIVOT)

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00007644
First received: December 29, 2000
Last updated: April 24, 2014
Last verified: April 2014
Results First Received: August 15, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Cancer
Intervention: Procedure: Radical prostatectomy

  Participant Flow
  Hide 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
  Description
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  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide 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
  Description
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  
Number of Participants  
[units: participants]
  364     367     731  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     122     131     253  
>=65 years     242     236     478  
Age  
[units: years]
Mean ± Standard Deviation
  67.0  ± 5.2     66.8  ± 5.6     66.9  ± 5.4  
Gender  
[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 posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide 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
e-mail: timothy.wilt@va.gov


Publications of Results:


Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00007644     History of Changes
Obsolete Identifiers: NCT00002606
Other Study ID Numbers: 407
Study First Received: December 29, 2000
Results First Received: August 15, 2013
Last Updated: April 24, 2014
Health Authority: United States: Federal Government