Screening for Prostate Cancer in Older Patients (PLCO Screening Trial)
Study Details
Study Description
Brief Summary
This clinical trial studies whether screening methods used to diagnose cancer of the prostate, lung, colon, rectum, or ovaries can reduce deaths from these cancers. Screening tests may help doctors find cancer cells early and plan better treatment for prostate cancer.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
PRIMARY OBJECTIVES:
- To determine whether screening with digital rectal examination (DRE) plus serum prostate-specific antigen (PSA) can reduce mortality from prostate cancer in men aged 55-74 at entry.
SECONDARY OBJECTIVES:
-
To assess screening variables, other than mortality, for each of the interventions including sensitivity, specificity, and positive predictive value.
-
To assess the incidence, stage, and survival of cancer cases. III. To investigate the mortality predictive value of biologic and/or prognostic characterizations of tumor tissue as intermediate endpoints.
-
To conduct biomolecular and genetic research into factors associated with cancer carcinogenesis and promotion, as well as the early detection of these factors.
OUTLINE: Participants in the overall PLCO study are stratified by screening center, gender, and age (55-59 vs 60-64 vs 65-69 vs 70-74). Participants are randomized to 1 of 2 arms (control vs screening).
ARM I (Control): Participants receive standard medical care. Participants complete a Diet History Questionnaire (DHQ) at baseline.
ARM II (Prostate Screening): Participants undergo blood sample collection for PSA analysis at baseline and annually for 5 years. Serum that is not used in the study will be stored in an NCI biorepository. Participants also undergo a DRE at baseline and annually for 3 years. A scheduling and tracking procedure is implemented to ensure regular attendance at repeat screens for participants screened negative or for those who are designated suspicious or positive at screening but for whom subsequent diagnostic procedures do not reveal prostate cancer (follow-up diagnostic procedures are through their own medical care environment). Participants diagnosed with prostate cancer via a screening test are referred for treatment in accordance with current accepted practice for appropriate stage of disease, patient age, and medical condition; a procedure is provided for contact with qualified medical personnel to insure appropriate therapy.
Participants complete a Dietary Questionnaire (DQX) at baseline and DHQ at year 3. An Annual Study Update (ADU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident prostate cancers as all deaths that occur among both screened and control subjects during the trial.
After completion of screening, participants are followed up for at least 13 years.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
No Intervention: Control Participants receive standard medical care. Participants complete a DHQ at baseline. |
|
Active Comparator: Prostate Screening Participants undergo blood sample collection for PSA analysis at baseline and annually for 5 years. Serum that is not used in the study will be stored in an NCI biorepository. Participants also undergo a DRE at baseline and annually for 3 years. Participants complete a DQX at baseline and DHQ at year 3. An ADU (previously referred to as the PSH questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident prostate cancers as all deaths that occur among both screened and control subjects during the trial. |
Other: Laboratory Biomarker Analysis
Correlative studies
Procedure: Medical Examination
Undergo DRE
Other Names:
Other: Screening Questionnaire Administration
Undergo questionnaire assessments
|
Outcome Measures
Primary Outcome Measures
- Prostate Cancer Deaths [Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.]
Prostate cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate.
- Prostate Cancer Death Rates [Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.]
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.
Secondary Outcome Measures
- Deaths From All Causes [Events through 13 years of follow-up or through December 31, 2009.]
Deaths from all causes were compared between the prostate cancer screening arm and the usual care arm.
- Death Rates From All Causes [Events through 13 years of follow-up or through December 31, 2009.]
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.
- Prostate Cancer Incidence [Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.]
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.
- Prostate Cancer Incidence Rates [Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.]
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.
- Complications of Diagnostic Evaluation (DE) Following a Positive Screening Test [One year from screening examination]
Number of positive screens with complications
- T0 (Baseline) PSA Screening Results [T0 (at study entry)]
Prostate-Specific Antigen (PSA) result.
- T0 (Baseline) DRE Screening Results [T0 (at study entry)]
Digital Rectal Examination (DRE) result.
- T1 PSA Screening Results [T1 (one year after entry)]
Prostate-Specific Antigen (PSA) result.
- T1 DRE Screening Results [T1 (one year after entry)]
Digital Rectal Examination (DRE) result.
- T2 PSA Screening Results [T2 (two years after entry)]
Prostate-Specific Antigen (PSA) result.
- T2 DRE Screening Results [T2 (two years after entry)]
Digital Rectal Examination (DRE) results
- T3 PSA Screening Results [T3 (three years after entry)]
Prostate-Specific Antigen (PSA) result
- T3 DRE Screening Results [T3 (three years after entry)]
Digital Rectal examination (DRE) result
- T4 PSA Screening Result [T4 (four years after entry)]
Prostate-Specific Antigen (PSA) result
- T5 PSA Screening Results [T5 (five years after entry)]
Prostate-Specific Antigen (PSA) result.
Eligibility Criteria
Criteria
Exclusion Criteria:
-
Men who at the time of randomization are less than 55 or greater than or equal to 75 years of age
-
Individuals undergoing treatment for cancer at this time, excluding basal-cell and squamous-cell skin cancer
-
Individuals with known prior cancer of the colon, rectum, lung, prostate
-
This includes primary or metastatic PLCO cancers
-
Individuals with previous surgical removal of the entire colon, one lung, or the entire prostate
-
Individuals who are participating in another cancer screening or cancer primary prevention trial
-
Males who have taken Proscar/Propecia/finasteride in the past 6 months
-
NOTE: Individuals who are already enrolled in the trial when their physician prescribes finasteride are not prevented from taking this medication. As a result, these participants will continue to be screened and followed just as those participants who are not on finasteride.
-
NOTE: Men who are taking Tamoxifen are not excluded from any part of the PLCO Screening Trial.
-
Individuals who are unwilling or unable to sign the informed consent form
-
Males who have had more than one PSA blood test in the past three years
-
Individuals who have had a colonoscopy, sigmoidoscopy, or barium enema in the past three years
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | National Institutes of Health Clinical Center | Bethesda | Maryland | United States | 20892 |
Sponsors and Collaborators
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Christine D Berg, National Cancer Institute (NCI)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NCI-2012-01755
- NCI-2012-01755
- CDR0000078532
- NCI-P93-0050
- PLCO-1
- PLCO-Prostate
Study Results
Participant Flow
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 Detail | Participants signed a study informed consent prior to being randomized to a study arm. |
Arm/Group Title | Control | Prostate Screening |
---|---|---|
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 |
Baseline Characteristics
Arm/Group Title | Control | Prostate Screening | Total |
---|---|---|---|
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 Participants | 38345 | 38340 | 76685 |
Age (Count of Participants) | |||
<=18 years |
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 (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
62.7
(5.3)
|
62.7
(5.3)
|
62.7
(5.3)
|
Sex: Female, Male (Count of Participants) | |||
Female |
0
0%
|
0
0%
|
0
0%
|
Male |
38345
100%
|
38340
100%
|
76685
100%
|
Region of Enrollment (participants) [Number] | |||
United States |
38345
100%
|
38340
100%
|
76685
100%
|
Outcome Measures
Title | Prostate Cancer Deaths |
---|---|
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. |
Outcome Measure Data
Analysis Population Description |
---|
All male participants randomized were analyzed. An intention-to-treat analysis was performed. |
Arm/Group Title | Control | Prostate Screening |
---|---|---|
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. |
Measure Participants | 38345 | 38340 |
Number [Participants] |
145
0.4%
|
158
0.4%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Control, Prostate Screening |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 1.09 | |
Confidence Interval |
(2-Sided) 95% 0.87 to 1.36 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Deaths From All Causes |
---|---|
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. |
Outcome Measure Data
Analysis Population Description |
---|
All male participants were analyzed. An intention-to-treat analysis was performed. |
Arm/Group Title | Control | Prostate Screening |
---|---|---|
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. |
Measure Participants | 38345 | 38340 |
Number [Participants] |
7089
18.5%
|
6855
17.9%
|
Title | Death Rates From All Causes |
---|---|
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. |
Outcome Measure Data
Analysis Population Description |
---|
All male participants were analyzed. An intention-to-treat analysis was performed. |
Arm/Group Title | Control | Prostate Screening |
---|---|---|
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. |
Measure Participants | 38345 | 38340 |
Number [Deaths per 10,000 PY] |
166.6
|
160.5
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Control, Prostate Screening |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.96 | |
Confidence Interval |
(2-Sided) 95% 0.93 to 1.00 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Prostate Cancer Incidence |
---|---|
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. |
Outcome Measure Data
Analysis Population Description |
---|
All male participants randomized were analyzed. An intention-to-treat analysis was performed. |
Arm/Group Title | Control | Prostate Screening |
---|---|---|
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. |
Measure Participants | 38345 | 38340 |
Number [Participants] |
3815
9.9%
|
4250
11.1%
|
Title | Prostate Cancer Incidence Rates |
---|---|
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. |
Outcome Measure Data
Analysis Population Description |
---|
All male participants randomized were analyzed. An intention-to-treat analysis was performed. |
Arm/Group Title | Control | Prostate Screening |
---|---|---|
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. |
Measure Participants | 38345 | 38340 |
Number [Diagnoses per 10,000 PY] |
97.1
|
108.4
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Control, Prostate Screening |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 1.12 | |
Confidence Interval |
(2-Sided) 95% 1.07 to 1.17 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Complications of Diagnostic Evaluation (DE) Following a Positive Screening Test |
---|---|
Description | Number of positive screens with complications |
Time Frame | One year from screening examination |
Outcome Measure Data
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 |
---|---|
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. |
Measure Participants | 10642 |
Measure Positive Screens with Follow-up | 22269 |
When DE Led to Prostate Cancer Diagnosis |
901
|
When DE Did Not Lead to Prostate Cancer Diagnosis |
124
|
Title | T0 (Baseline) PSA Screening Results |
---|---|
Description | Prostate-Specific Antigen (PSA) result. |
Time Frame | T0 (at study entry) |
Outcome Measure Data
Analysis Population Description |
---|
All males in the Prostate Screening arm who had a PSA screen at T0 were analyzed. |
Arm/Group Title | Prostate Screening |
---|---|
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. |
Measure Participants | 34247 |
Negative (<=4 ng/mL) |
31507
82.2%
|
Positive (> 4 ng/mL) |
2718
7.1%
|
Inadequate screen |
22
0.1%
|
Title | T0 (Baseline) DRE Screening Results |
---|---|
Description | Digital Rectal Examination (DRE) result. |
Time Frame | T0 (at study entry) |
Outcome Measure Data
Analysis Population Description |
---|
All males in the Prostate Screening arm who had a DRE screen at T0 were analyzed. |
Arm/Group Title | Prostate Screening |
---|---|
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. |
Measure Participants | 34129 |
Negative |
30456
79.4%
|
Positive |
2481
6.5%
|
Inadequate screen |
1192
3.1%
|
Title | T1 PSA Screening Results |
---|---|
Description | Prostate-Specific Antigen (PSA) result. |
Time Frame | T1 (one year after entry) |
Outcome Measure Data
Analysis Population Description |
---|
All males in the Prostate Screening arm who had a PSA screen at T1 were analyzed. |
Arm/Group Title | Prostate Screening |
---|---|
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. |
Measure Participants | 32688 |
Negative (<=4 ng/mL) |
30159
78.7%
|
Positive (> 4 ng/mL) |
2502
6.5%
|
Inadequate screen |
27
0.1%
|
Title | T1 DRE Screening Results |
---|---|
Description | Digital Rectal Examination (DRE) result. |
Time Frame | T1 (one year after entry) |
Outcome Measure Data
Analysis Population Description |
---|
All males in the Prostate Screening arm who had a DRE screen at T1 were analyzed. |
Arm/Group Title | Prostate Screening |
---|---|
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. |
Measure Participants | 32448 |
Negative |
29311
76.4%
|
Positive |
2237
5.8%
|
Inadequate screen |
900
2.3%
|
Title | T2 PSA Screening Results |
---|---|
Description | Prostate-Specific Antigen (PSA) result. |
Time Frame | T2 (two years after entry) |
Outcome Measure Data
Analysis Population Description |
---|
All males in the Prostate Screening arm who had a PSA screen at T2 were analyzed. |
Arm/Group Title | Prostate Screening |
---|---|
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. |
Measure Participants | 31691 |
Negative |
29063
75.8%
|
Positive (> 4 ng/mL) |
2593
6.8%
|
Inadequate screen |
35
0.1%
|
Title | T2 DRE Screening Results |
---|---|
Description | Digital Rectal Examination (DRE) results |
Time Frame | T2 (two years after entry) |
Outcome Measure Data
Analysis Population Description |
---|
All males in the Prostate Screening arm who had a DRE screen at T2 were analyzed. |
Arm/Group Title | Prostate Screening |
---|---|
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. |
Measure Participants | 31451 |
Negative |
28391
74%
|
Positive |
2327
6.1%
|
Inadequate screen |
733
1.9%
|
Title | T3 PSA Screening Results |
---|---|
Description | Prostate-Specific Antigen (PSA) result |
Time Frame | T3 (three years after entry) |
Outcome Measure Data
Analysis Population Description |
---|
All males in the Prostate Screening arm who had a PSA screen at T3 were analyzed. |
Arm/Group Title | Prostate Screening |
---|---|
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. |
Measure Participants | 30533 |
Negative (<=4 ng/mL) |
27814
72.5%
|
Positive (> 4 ng/mL) |
2676
7%
|
Inadequate screen |
43
0.1%
|
Title | T3 DRE Screening Results |
---|---|
Description | Digital Rectal examination (DRE) result |
Time Frame | T3 (three years after entry) |
Outcome Measure Data
Analysis Population Description |
---|
All males in the Prostate Screening arm who had a DRE screen at T3 were analyzed. |
Arm/Group Title | Prostate Screening |
---|---|
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. |
Measure Participants | 30244 |
Negative |
27179
70.9%
|
Positive |
2317
6%
|
Inadequate screen |
748
2%
|
Title | Prostate Cancer Death Rates |
---|---|
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. |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Control | Prostate Screening |
---|---|---|
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. |
Measure Participants | 38345 | 38340 |
Number [Deaths per 10,000 PY] |
3.4
|
3.7
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Control, Prostate Screening |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 1.09 | |
Confidence Interval |
(2-Sided) 95% 0.87 to 1.36 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | T4 PSA Screening Result |
---|---|
Description | Prostate-Specific Antigen (PSA) result |
Time Frame | T4 (four years after entry) |
Outcome Measure Data
Analysis Population Description |
---|
All males in the Prostate Screening arm who had a PSA screen at T4 were analyzed. |
Arm/Group Title | Prostate Screening |
---|---|
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. |
Measure Participants | 22170 |
Negative (<=4 ng/mL) |
20362
53.1%
|
Positive (> 4 ng/mL) |
1796
4.7%
|
Inadequate screen |
12
0%
|
Title | T5 PSA Screening Results |
---|---|
Description | Prostate-Specific Antigen (PSA) result. |
Time Frame | T5 (five years after entry) |
Outcome Measure Data
Analysis Population Description |
---|
All males in the Prostate Screening arm who had a PSA screen at T5 were analyzed. |
Arm/Group Title | Prostate Screening |
---|---|
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. |
Measure Participants | 25951 |
Negative (<=4 ng/mL) |
23560
61.4%
|
Positive (> 4 ng/mL) |
2377
6.2%
|
Inadequate screen |
14
0%
|
Adverse Events
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 | |
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 (%) | # Events | |
Total | / (NaN) | |
Serious Adverse Events |
||
Prostate Screening | ||
Affected / at Risk (%) | # Events | |
Total | 0/38340 (0%) | |
Other (Not Including Serious) Adverse Events |
||
Prostate Screening | ||
Affected / at Risk (%) | # Events | |
Total | 546/38340 (1.4%) | |
General disorders | ||
Anxiety | 1/38340 (0%) | 1 |
Bleeding | 3/38340 (0%) | 3 |
Dizzy | 101/38340 (0.3%) | 108 |
Fainted | 58/38340 (0.2%) | 59 |
Inflammation | 2/38340 (0%) | 2 |
Nausea | 1/38340 (0%) | 1 |
Pain | 11/38340 (0%) | 11 |
Bruising | 182/38340 (0.5%) | 183 |
Hematoma | 187/38340 (0.5%) | 190 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Name/Title | Paul F. Pinsky, Ph.D. |
---|---|
Organization | Early Detection Research Group, NCI, NIH |
Phone | 301-496-8544 |
pinskyp@mail.nih.gov |
- NCI-2012-01755
- NCI-2012-01755
- CDR0000078532
- NCI-P93-0050
- PLCO-1
- PLCO-Prostate