ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 2 for:    00002540
Previous Study | Return to List | Next Study

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

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.
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
Enrollment 76685
Recruitment Details 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 Participants signed a study informed consent prior to being randomized to a study arm.
Arm/Group Title Control Prostate Screening
Hide Arm/Group Description Participants receive standard medical care. 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.
Period Title: Overall Study
Started 38345 38340
Completed 37544 35876
Not Completed 801 2464
Reason Not Completed
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
Arm/Group Title Control Prostate Screening Total
Hide Arm/Group Description Participants receive standard medical care. 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 of all reporting groups
Overall Number of Baseline Participants 38345 38340 76685
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38345 participants 38340 participants 76685 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, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38345 participants 38340 participants 76685 participants
62.7  (5.3) 62.7  (5.3) 62.7  (5.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38345 participants 38340 participants 76685 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
38345
 100.0%
38340
 100.0%
76685
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 38345 participants 38340 participants 76685 participants
38345 38340 76685
1.Primary Outcome
Title Prostate Cancer Deaths
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All male participants randomized were analyzed. An intention-to-treat analysis was performed.
Arm/Group Title Control Prostate Screening
Hide Arm/Group Description:
Participants receive standard medical care.
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.
Overall Number of Participants Analyzed 38345 38340
Measure Type: Number
Unit of Measure: Participants
145 158
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Prostate Screening
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Two-sided. Not adjusted for multiple comparisons. A-priori threshold for significance 0.05.
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
0.87 to 1.36
Estimation Comments [Not Specified]
2.Primary Outcome
Title Prostate Cancer Death Rates
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Prostate Screening
Hide Arm/Group Description:
Participants receive standard medical care.
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.
Overall Number of Participants Analyzed 38345 38340
Measure Type: Number
Unit of Measure: Deaths per 10,000 PY
3.4 3.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Prostate Screening
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
0.87 to 1.36
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Deaths From All Causes
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All male participants were analyzed. An intention-to-treat analysis was performed.
Arm/Group Title Control Prostate Screening
Hide Arm/Group Description:
Participants receive standard medical care.
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.
Overall Number of Participants Analyzed 38345 38340
Measure Type: Number
Unit of Measure: Participants
7089 6855
4.Secondary Outcome
Title Death Rates From All Causes
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All male participants were analyzed. An intention-to-treat analysis was performed.
Arm/Group Title Control Prostate Screening
Hide Arm/Group Description:
Participants receive standard medical care.
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.
Overall Number of Participants Analyzed 38345 38340
Measure Type: Number
Unit of Measure: Deaths per 10,000 PY
166.6 160.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Prostate Screening
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Poisson regression
Comments Two-sided. Not adjusted for multiple comparisons. A-priori threshold for significance 0.05.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.93 to 1.00
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Prostate Cancer Incidence
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All male participants randomized were analyzed. An intention-to-treat analysis was performed.
Arm/Group Title Control Prostate Screening
Hide Arm/Group Description:
Participants receive standard medical care.
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.
Overall Number of Participants Analyzed 38345 38340
Measure Type: Number
Unit of Measure: Participants
3815 4250
6.Secondary Outcome
Title Prostate Cancer Incidence Rates
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All male participants randomized were analyzed. An intention-to-treat analysis was performed.
Arm/Group Title Control Prostate Screening
Hide Arm/Group Description:
Participants receive standard medical care.
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.
Overall Number of Participants Analyzed 38345 38340
Measure Type: Number
Unit of Measure: Diagnoses per 10,000 PY
97.1 108.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Prostate Screening
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Poisson regression
Comments Two-sided. Not adjusted for multiple comparisons. A-priori threshold for significance 0.05.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.12
Confidence Interval (2-Sided) 95%
1.07 to 1.17
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Complications of Diagnostic Evaluation (DE) Following a Positive Screening Test
Hide Description Number of positive screens with complications
Time Frame One year from screening examination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Prostate Screening
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 10642
Overall Number of Units Analyzed
Type of Units Analyzed: Positive Screens with Follow-up
22269
Measure Type: Number
Unit of Measure: Positive screens w/ complications
When DE Led to Prostate Cancer Diagnosis 901
When DE Did Not Lead to Prostate Cancer Diagnosis 124
8.Secondary Outcome
Title T0 (Baseline) PSA Screening Results
Hide Description Prostate-Specific Antigen (PSA) result.
Time Frame T0 (at study entry)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All males in the Prostate Screening arm who had a PSA screen at T0 were analyzed.
Arm/Group Title Prostate Screening
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 34247
Measure Type: Number
Unit of Measure: Participants
Negative (<=4 ng/mL) 31507
Positive (> 4 ng/mL) 2718
Inadequate screen 22
9.Secondary Outcome
Title T0 (Baseline) DRE Screening Results
Hide Description Digital Rectal Examination (DRE) result.
Time Frame T0 (at study entry)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All males in the Prostate Screening arm who had a DRE screen at T0 were analyzed.
Arm/Group Title Prostate Screening
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 34129
Measure Type: Number
Unit of Measure: Participants
Negative 30456
Positive 2481
Inadequate screen 1192
10.Secondary Outcome
Title T1 PSA Screening Results
Hide Description Prostate-Specific Antigen (PSA) result.
Time Frame T1 (one year after entry)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All males in the Prostate Screening arm who had a PSA screen at T1 were analyzed.
Arm/Group Title Prostate Screening
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 32688
Measure Type: Number
Unit of Measure: Participants
Negative (<=4 ng/mL) 30159
Positive (> 4 ng/mL) 2502
Inadequate screen 27
11.Secondary Outcome
Title T1 DRE Screening Results
Hide Description Digital Rectal Examination (DRE) result.
Time Frame T1 (one year after entry)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All males in the Prostate Screening arm who had a DRE screen at T1 were analyzed.
Arm/Group Title Prostate Screening
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 32448
Measure Type: Number
Unit of Measure: Participants
Negative 29311
Positive 2237
Inadequate screen 900
12.Secondary Outcome
Title T2 PSA Screening Results
Hide Description Prostate-Specific Antigen (PSA) result.
Time Frame T2 (two years after entry)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All males in the Prostate Screening arm who had a PSA screen at T2 were analyzed.
Arm/Group Title Prostate Screening
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 31691
Measure Type: Number
Unit of Measure: Participants
Negative 29063
Positive (> 4 ng/mL) 2593
Inadequate screen 35
13.Secondary Outcome
Title T2 DRE Screening Results
Hide Description Digital Rectal Examination (DRE) results
Time Frame T2 (two years after entry)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All males in the Prostate Screening arm who had a DRE screen at T2 were analyzed.
Arm/Group Title Prostate Screening
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 31451
Measure Type: Number
Unit of Measure: Participants
Negative 28391
Positive 2327
Inadequate screen 733
14.Secondary Outcome
Title T3 PSA Screening Results
Hide Description Prostate-Specific Antigen (PSA) result
Time Frame T3 (three years after entry)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All males in the Prostate Screening arm who had a PSA screen at T3 were analyzed.
Arm/Group Title Prostate Screening
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 30533
Measure Type: Number
Unit of Measure: Participants
Negative (<=4 ng/mL) 27814
Positive (> 4 ng/mL) 2676
Inadequate screen 43
15.Secondary Outcome
Title T3 DRE Screening Results
Hide Description Digital Rectal examination (DRE) result
Time Frame T3 (three years after entry)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All males in the Prostate Screening arm who had a DRE screen at T3 were analyzed.
Arm/Group Title Prostate Screening
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 30244
Measure Type: Number
Unit of Measure: Participants
Negative 27179
Positive 2317
Inadequate screen 748
16.Secondary Outcome
Title T4 PSA Screening Result
Hide Description Prostate-Specific Antigen (PSA) result
Time Frame T4 (four years after entry)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All males in the Prostate Screening arm who had a PSA screen at T4 were analyzed.
Arm/Group Title Prostate Screening
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 22170
Measure Type: Number
Unit of Measure: Participants
Negative (<=4 ng/mL) 20362
Positive (> 4 ng/mL) 1796
Inadequate screen 12
17.Secondary Outcome
Title T5 PSA Screening Results
Hide Description Prostate-Specific Antigen (PSA) result.
Time Frame T5 (five years after entry)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All males in the Prostate Screening arm who had a PSA screen at T5 were analyzed.
Arm/Group Title Prostate Screening
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 25951
Measure Type: Number
Unit of Measure: Participants
Negative (<=4 ng/mL) 23560
Positive (> 4 ng/mL) 2377
Inadequate screen 14
Time Frame During each annual screening visit.
Adverse Event Reporting Description These events are solely those prompted by the screening examination.
 
Arm/Group Title Prostate Screening
Hide Arm/Group Description 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.
All-Cause Mortality
Prostate Screening
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Prostate Screening
Affected / at Risk (%) # Events
Total   0/38340 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Prostate Screening
Affected / at Risk (%) # Events
Total   546/38340 (1.42%)    
General disorders   
Anxiety *  1/38340 (0.00%)  1
Bleeding *  3/38340 (0.01%)  3
Dizzy *  101/38340 (0.26%)  108
Fainted *  58/38340 (0.15%)  59
Inflammation *  2/38340 (0.01%)  2
Nausea *  1/38340 (0.00%)  1
Pain *  11/38340 (0.03%)  11
Bruising *  182/38340 (0.47%)  183
Hematoma *  187/38340 (0.49%)  190
*
Indicates events were collected by non-systematic assessment
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.
Results Point of Contact
Name/Title: Paul F. Pinsky, Ph.D.
Organization: Early Detection Research Group, NCI, NIH
Phone: 301-496-8544
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