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Trial record 4 of 4 for:    PLCO-1

Screening for Prostate Cancer in Older Patients (PLCO Screening Trial)

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ClinicalTrials.gov Identifier: NCT00002540
Recruitment Status : Active, not recruiting
First Posted : March 26, 2004
Results First Posted : June 26, 2014
Last Update Posted : August 23, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Screening
Condition: Prostate Carcinoma
Interventions: Other: Laboratory Biomarker Analysis
Procedure: Medical Examination
Other: Screening Questionnaire Administration

  Participant Flow

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

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 
Overall Participants Analyzed 
[Units: Participants]
 38345   38340   76685 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      24390  63.6%      24400  63.6%      48790  63.6% 
>=65 years      13955  36.4%      13940  36.4%      27895  36.4% 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.7  (5.3)   62.7  (5.3)   62.7  (5.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      38345 100.0%      38340 100.0%      76685 100.0% 
Region of Enrollment 
[Units: Participants]
     
United States   38345   38340   76685 


  Outcome Measures

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. ]

Measure Type Primary
Measure Title Prostate Cancer Deaths
Measure Description Prostate cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate.
Time Frame Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.  

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.
All male participants randomized were analyzed. An intention-to-treat analysis was performed.

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.

Measured Values
   Control   Prostate Screening 
Participants Analyzed   38345   38340 
Prostate Cancer Deaths 
[Units: Participants]
 145   158 


Statistical Analysis 1 for Prostate Cancer Deaths
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Poisson regression
Hazard Ratio (HR) [4] 1.09
95% Confidence Interval 0.87 to 1.36
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



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. ]

Measure Type Primary
Measure Title Prostate Cancer Death Rates
Measure Description Prostate cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate. Rate is the number of deaths divided by person years of follow-up in the study.
Time Frame Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.  

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.

Measured Values
   Control   Prostate Screening 
Participants Analyzed   38345   38340 
Prostate Cancer Death Rates 
[Units: Deaths per 10,000 PY]
 3.4   3.7 


Statistical Analysis 1 for Prostate Cancer Death Rates
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Poisson regression
Hazard Ratio (HR) [4] 1.09
95% Confidence Interval 0.87 to 1.36
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



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

Measure Type Secondary
Measure Title Deaths From All Causes
Measure Description Deaths from all causes were compared between the prostate cancer screening arm and the usual care arm.
Time Frame Events through 13 years of follow-up or through December 31, 2009.  

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.
All male participants were analyzed. An intention-to-treat analysis was performed.

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.

Measured Values
   Control   Prostate Screening 
Participants Analyzed   38345   38340 
Deaths From All Causes 
[Units: Participants]
 7089   6855 

No statistical analysis provided for Deaths From All Causes



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

Measure Type Secondary
Measure Title Death Rates From All Causes
Measure Description Deaths from all causes were compared between the prostate cancer screening arm and the usual care arm. Rate is the number of deaths divided by person years of follow-up in the study.
Time Frame Events through 13 years of follow-up or through December 31, 2009.  

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.
All male participants were analyzed. An intention-to-treat analysis was performed.

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.

Measured Values
   Control   Prostate Screening 
Participants Analyzed   38345   38340 
Death Rates From All Causes 
[Units: Deaths per 10,000 PY]
 166.6   160.5 


Statistical Analysis 1 for Death Rates From All Causes
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Poisson regression
Hazard Ratio (HR) [4] 0.96
95% Confidence Interval 0.93 to 1.00
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Two-sided. Not adjusted for multiple comparisons. A-priori threshold for significance 0.05.
[4] Other relevant estimation information:
  No text entered.



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. ]

Measure Type Secondary
Measure Title Prostate Cancer Incidence
Measure Description Prostate cancer diagnoses confirmed by medical record abstraction. Incidence rate (cumulative) defined as prostate cancer diagnoses divided by person years at risk for prostate cancer.
Time Frame Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.  

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.
All male participants randomized were analyzed. An intention-to-treat analysis was performed.

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.

Measured Values
   Control   Prostate Screening 
Participants Analyzed   38345   38340 
Prostate Cancer Incidence 
[Units: Participants]
 3815   4250 

No statistical analysis provided for Prostate Cancer Incidence



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. ]

Measure Type Secondary
Measure Title Prostate Cancer Incidence Rates
Measure Description Prostate cancer diagnoses confirmed by medical record abstraction. Incidence rate (cumulative) defined as prostate cancer diagnoses divided by person years at risk for prostate cancer.
Time Frame Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.  

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.
All male participants randomized were analyzed. An intention-to-treat analysis was performed.

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.

Measured Values
   Control   Prostate Screening 
Participants Analyzed   38345   38340 
Prostate Cancer Incidence Rates 
[Units: Diagnoses per 10,000 PY]
 97.1   108.4 


Statistical Analysis 1 for Prostate Cancer Incidence Rates
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Poisson regression
Hazard Ratio (HR) [4] 1.12
95% Confidence Interval 1.07 to 1.17
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Two-sided. Not adjusted for multiple comparisons. A-priori threshold for significance 0.05.
[4] Other relevant estimation information:
  No text entered.



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

Measure Type Secondary
Measure Title Complications of Diagnostic Evaluation (DE) Following a Positive Screening Test
Measure Description Number of positive screens with complications
Time Frame One year from screening examination  

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.
The units analyzed were positive screening exams with documented diagnostic follow-up. If a participant received 3 positive screens with documented follow-up after each one, he would be counted 3 times in the number of units analyzed.

Reporting Groups
  Description
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.

Measured Values
   Prostate Screening 
Participants Analyzed   10642 
Units Analyzed (Positive Screens with Follow-up)   22269 
Complications of Diagnostic Evaluation (DE) Following a Positive Screening Test 
[Units: Positive screens w/ complications]
 
When DE Led to Prostate Cancer Diagnosis   901 
When DE Did Not Lead to Prostate Cancer Diagnosis   124 

No statistical analysis provided for Complications of Diagnostic Evaluation (DE) Following a Positive Screening Test



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

Measure Type Secondary
Measure Title T0 (Baseline) PSA Screening Results
Measure Description Prostate-Specific Antigen (PSA) result.
Time Frame T0 (at study entry)  

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.
All males in the Prostate Screening arm who had a PSA screen at T0 were analyzed.

Reporting Groups
  Description
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.

Measured Values
   Prostate Screening 
Participants Analyzed   34247 
T0 (Baseline) PSA Screening Results 
[Units: Participants]
 
Negative (<=4 ng/mL)   31507 
Positive (> 4 ng/mL)   2718 
Inadequate screen   22 

No statistical analysis provided for T0 (Baseline) PSA Screening Results



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

Measure Type Secondary
Measure Title T0 (Baseline) DRE Screening Results
Measure Description Digital Rectal Examination (DRE) result.
Time Frame T0 (at study entry)  

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.
All males in the Prostate Screening arm who had a DRE screen at T0 were analyzed.

Reporting Groups
  Description
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.

Measured Values
   Prostate Screening 
Participants Analyzed   34129 
T0 (Baseline) DRE Screening Results 
[Units: Participants]
 
Negative   30456 
Positive   2481 
Inadequate screen   1192 

No statistical analysis provided for T0 (Baseline) DRE Screening Results



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

Measure Type Secondary
Measure Title T1 PSA Screening Results
Measure Description Prostate-Specific Antigen (PSA) result.
Time Frame T1 (one year after entry)  

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.
All males in the Prostate Screening arm who had a PSA screen at T1 were analyzed.

Reporting Groups
  Description
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.

Measured Values
   Prostate Screening 
Participants Analyzed   32688 
T1 PSA Screening Results 
[Units: Participants]
 
Negative (<=4 ng/mL)   30159 
Positive (> 4 ng/mL)   2502 
Inadequate screen   27 

No statistical analysis provided for T1 PSA Screening Results



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

Measure Type Secondary
Measure Title T1 DRE Screening Results
Measure Description Digital Rectal Examination (DRE) result.
Time Frame T1 (one year after entry)  

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.
All males in the Prostate Screening arm who had a DRE screen at T1 were analyzed.

Reporting Groups
  Description
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.

Measured Values
   Prostate Screening 
Participants Analyzed   32448 
T1 DRE Screening Results 
[Units: Participants]
 
Negative   29311 
Positive   2237 
Inadequate screen   900 

No statistical analysis provided for T1 DRE Screening Results



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

Measure Type Secondary
Measure Title T2 PSA Screening Results
Measure Description Prostate-Specific Antigen (PSA) result.
Time Frame T2 (two years after entry)  

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.
All males in the Prostate Screening arm who had a PSA screen at T2 were analyzed.

Reporting Groups
  Description
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.

Measured Values
   Prostate Screening 
Participants Analyzed   31691 
T2 PSA Screening Results 
[Units: Participants]
 
Negative   29063 
Positive (> 4 ng/mL)   2593 
Inadequate screen   35 

No statistical analysis provided for T2 PSA Screening Results



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

Measure Type Secondary
Measure Title T2 DRE Screening Results
Measure Description Digital Rectal Examination (DRE) results
Time Frame T2 (two years after entry)  

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.
All males in the Prostate Screening arm who had a DRE screen at T2 were analyzed.

Reporting Groups
  Description
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.

Measured Values
   Prostate Screening 
Participants Analyzed   31451 
T2 DRE Screening Results 
[Units: Participants]
 
Negative   28391 
Positive   2327 
Inadequate screen   733 

No statistical analysis provided for T2 DRE Screening Results



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

Measure Type Secondary
Measure Title T3 PSA Screening Results
Measure Description Prostate-Specific Antigen (PSA) result
Time Frame T3 (three years after entry)  

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.
All males in the Prostate Screening arm who had a PSA screen at T3 were analyzed.

Reporting Groups
  Description
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.

Measured Values
   Prostate Screening 
Participants Analyzed   30533 
T3 PSA Screening Results 
[Units: Participants]
 
Negative (<=4 ng/mL)   27814 
Positive (> 4 ng/mL)   2676 
Inadequate screen   43 

No statistical analysis provided for T3 PSA Screening Results



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

Measure Type Secondary
Measure Title T3 DRE Screening Results
Measure Description Digital Rectal examination (DRE) result
Time Frame T3 (three years after entry)  

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.
All males in the Prostate Screening arm who had a DRE screen at T3 were analyzed.

Reporting Groups
  Description
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.

Measured Values
   Prostate Screening 
Participants Analyzed   30244 
T3 DRE Screening Results 
[Units: Participants]
 
Negative   27179 
Positive   2317 
Inadequate screen   748 

No statistical analysis provided for T3 DRE Screening Results



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

Measure Type Secondary
Measure Title T4 PSA Screening Result
Measure Description Prostate-Specific Antigen (PSA) result
Time Frame T4 (four years after entry)  

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.
All males in the Prostate Screening arm who had a PSA screen at T4 were analyzed.

Reporting Groups
  Description
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.

Measured Values
   Prostate Screening 
Participants Analyzed   22170 
T4 PSA Screening Result 
[Units: Participants]
 
Negative (<=4 ng/mL)   20362 
Positive (> 4 ng/mL)   1796 
Inadequate screen   12 

No statistical analysis provided for T4 PSA Screening Result



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

Measure Type Secondary
Measure Title T5 PSA Screening Results
Measure Description Prostate-Specific Antigen (PSA) result.
Time Frame T5 (five years after entry)  

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.
All males in the Prostate Screening arm who had a PSA screen at T5 were analyzed.

Reporting Groups
  Description
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.

Measured Values
   Prostate Screening 
Participants Analyzed   25951 
T5 PSA Screening Results 
[Units: Participants]
 
Negative (<=4 ng/mL)   23560 
Positive (> 4 ng/mL)   2377 
Inadequate screen   14 

No statistical analysis provided for T5 PSA Screening Results




  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:  
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


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


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002540     History of Changes
Other Study ID Numbers: NCI-2012-01755
NCI-2012-01755 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
PLCO-1
CDR0000078532
PLCO-Prostate ( Other Identifier: National Institutes of Health Clinical Center )
NCI-P93-0050 ( Other Identifier: DCP )
First Submitted: November 1, 1999
First Posted: March 26, 2004
Results First Submitted: August 30, 2013
Results First Posted: June 26, 2014
Last Update Posted: August 23, 2018