Trial record 1 of 3 for:    NCT00002540
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Screening for Prostate Cancer in Older Patients (PLCO Screening Trial)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002540
First received: November 1, 1999
Last updated: June 19, 2014
Last verified: June 2014
Results First Received: August 30, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Screening
Condition: Prostate Cancer
Interventions: Procedure: examination
Other: screening questionnaire administration
Other: laboratory biomarker analysis

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled between November 1993 and July 2001 at 10 study centers. Recruitment was done for all four outcomes of the study (prostate, lung, colorectal and ovarian).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants signed a study informed consent prior to being randomized to a study arm.

Reporting Groups
  Description
Control Participants receive standard medical care.
Prostate Screening Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.

Participant Flow:   Overall Study
    Control     Prostate Screening  
STARTED     38345     38340  
COMPLETED     37544     35876  
NOT COMPLETED     801     2464  
Cancer Before Rand. (Prostate Screening)                 0                 25  
Died Before Randomization                 2                 6  
Died Before ASU (Control)                 202                 0  
Refused ASU (Control)                 597                 0  
Refused Screen (Prostate Screening)                 0                 2433  



  Baseline Characteristics
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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
Control Participants receive standard medical care.
Prostate Screening Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
Total Total of all reporting groups

Baseline Measures
    Control     Prostate Screening     Total  
Number of Participants  
[units: participants]
  38345     38340     76685  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     24390     24400     48790  
>=65 years     13955     13940     27895  
Age  
[units: years]
Mean ± Standard Deviation
  62.7  ± 5.3     62.7  ± 5.3     62.7  ± 5.3  
Gender  
[units: participants]
     
Female     0     0     0  
Male     38345     38340     76685  
Region of Enrollment  
[units: participants]
     
United States     38345     38340     76685  



  Outcome Measures
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1.  Primary:   Prostate Cancer Deaths   [ Time Frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years. ]

2.  Primary:   Prostate Cancer Death Rates   [ Time Frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years. ]

3.  Secondary:   Deaths From All Causes   [ Time Frame: Events through 13 years of follow-up or through December 31, 2009. ]

4.  Secondary:   Death Rates From All Causes   [ Time Frame: Events through 13 years of follow-up or through December 31, 2009. ]

5.  Secondary:   Prostate Cancer Incidence   [ Time Frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years. ]

6.  Secondary:   Prostate Cancer Incidence Rates   [ Time Frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years. ]

7.  Secondary:   Complications of Diagnostic Evaluation (DE) Following a Positive Screening Test   [ Time Frame: One year from screening examination ]

8.  Secondary:   T0 (Baseline) PSA Screening Results   [ Time Frame: T0 (at study entry) ]

9.  Secondary:   T0 (Baseline) DRE Screening Results   [ Time Frame: T0 (at study entry) ]

10.  Secondary:   T1 PSA Screening Results   [ Time Frame: T1 (one year after entry) ]

11.  Secondary:   T1 DRE Screening Results   [ Time Frame: T1 (one year after entry) ]

12.  Secondary:   T2 PSA Screening Results   [ Time Frame: T2 (two years after entry) ]

13.  Secondary:   T2 DRE Screening Results   [ Time Frame: T2 (two years after entry) ]

14.  Secondary:   T3 PSA Screening Results   [ Time Frame: T3 (three years after entry) ]

15.  Secondary:   T3 DRE Screening Results   [ Time Frame: T3 (three years after entry) ]

16.  Secondary:   T4 PSA Screening Result   [ Time Frame: T4 (four years after entry) ]

17.  Secondary:   T5 PSA Screening Results   [ Time Frame: T5 (five years after entry) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Paul F. Pinsky, Ph.D.
Organization: Early Detection Research Group, NCI, NIH
phone: 301-496-8544
e-mail: pinskyp@mail.nih.gov


No publications provided by National Cancer Institute (NCI)

Publications automatically indexed to this study:


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002540     History of Changes
Other Study ID Numbers: NCI-2012-01755, NCI-2012-01755, PLCO-1, CDR0000078532, PLCO-Prostate, NCI-P93-0050
Study First Received: November 1, 1999
Results First Received: August 30, 2013
Last Updated: June 19, 2014
Health Authority: United States: Institutional Review Board