Trial Outcomes & Findings for Screening for Prostate Cancer in Older Patients (PLCO Screening Trial) (NCT NCT00002540)

NCT ID: NCT00002540

Last Updated: 2025-07-23

Results Overview

Prostate cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: NA
• Target enrollment: 76685 participants
• Primary outcome timeframe: Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.
• Results posted on: 2025-07-23

Participant Flow

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).

Participants signed a study informed consent prior to being randomized to a study arm.

Participant milestones

Measure	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.
Overall Study STARTED	38345	38340
Overall Study COMPLETED	37544	35876
Overall Study NOT COMPLETED	801	2464

Reasons for withdrawal

Measure	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.
Overall Study Cancer Before Rand. (Prostate Screening)	0	25
Overall Study Died Before Randomization	2	6
Overall Study Died Before ASU (Control)	202	0
Overall Study Refused ASU (Control)	597	0
Overall Study Refused Screen (Prostate Screening)	0	2433

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Control n=38345 Participants Participants receive standard medical care.	Prostate Screening n=38340 Participants 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 n=76685 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	24390 Participants n=5 Participants	24400 Participants n=7 Participants	48790 Participants n=5 Participants
Age, Categorical >=65 years	13955 Participants n=5 Participants	13940 Participants n=7 Participants	27895 Participants n=5 Participants
Age, Continuous	62.7 years STANDARD_DEVIATION 5.3 • n=5 Participants	62.7 years STANDARD_DEVIATION 5.3 • n=7 Participants	62.7 years STANDARD_DEVIATION 5.3 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	38345 Participants n=5 Participants	38340 Participants n=7 Participants	76685 Participants n=5 Participants
Region of Enrollment United States	38345 participants n=5 Participants	38340 participants n=7 Participants	76685 participants n=5 Participants

PRIMARY outcome

Timeframe: Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.

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

Prostate cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate.

Outcome measures

Measure	Control n=38345 Participants Participants receive standard medical care.	Prostate Screening n=38340 Participants 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.
Prostate Cancer Deaths	145 Participants	158 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Control n=38345 Participants Participants receive standard medical care.	Prostate Screening n=38340 Participants 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.
Prostate Cancer Death Rates	3.4 Deaths per 10,000 PY	3.7 Deaths per 10,000 PY

SECONDARY outcome

Timeframe: Events through 13 years of follow-up or through December 31, 2009.

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

Deaths from all causes were compared between the prostate cancer screening arm and the usual care arm.

Outcome measures

Measure	Control n=38345 Participants Participants receive standard medical care.	Prostate Screening n=38340 Participants 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.
Deaths From All Causes	7089 Participants	6855 Participants

SECONDARY outcome

Timeframe: Events through 13 years of follow-up or through December 31, 2009.

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

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.

Outcome measures

Measure	Control n=38345 Participants Participants receive standard medical care.	Prostate Screening n=38340 Participants 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.
Death Rates From All Causes	166.6 Deaths per 10,000 PY	160.5 Deaths per 10,000 PY

SECONDARY outcome

Timeframe: Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.

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

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.

Outcome measures

Measure	Control n=38345 Participants Participants receive standard medical care.	Prostate Screening n=38340 Participants 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.
Prostate Cancer Incidence	3815 Participants	4250 Participants

SECONDARY outcome

Timeframe: Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.

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

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.

Outcome measures

Measure	Control n=38345 Participants Participants receive standard medical care.	Prostate Screening n=38340 Participants 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.
Prostate Cancer Incidence Rates	97.1 Diagnoses per 10,000 PY	108.4 Diagnoses per 10,000 PY

SECONDARY outcome

Timeframe: One year from screening examination

Population: 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.

Number of positive screens with complications

Outcome measures

Measure	Control n=22269 Positive Screens with Follow-up 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.
Complications of Diagnostic Evaluation (DE) Following a Positive Screening Test When DE Led to Prostate Cancer Diagnosis	901 Positive screens w/ complications	—
Complications of Diagnostic Evaluation (DE) Following a Positive Screening Test When DE Did Not Lead to Prostate Cancer Diagnosis	124 Positive screens w/ complications	—

SECONDARY outcome

Timeframe: T0 (at study entry)

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

Prostate-Specific Antigen (PSA) result.

Outcome measures

Measure	Control n=34247 Participants 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.
T0 (Baseline) PSA Screening Results Negative (<=4 ng/mL)	31507 Participants	—
T0 (Baseline) PSA Screening Results Positive (> 4 ng/mL)	2718 Participants	—
T0 (Baseline) PSA Screening Results Inadequate screen	22 Participants	—

SECONDARY outcome

Timeframe: T0 (at study entry)

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

Digital Rectal Examination (DRE) result.

Outcome measures

Measure	Control n=34129 Participants 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.
T0 (Baseline) DRE Screening Results Negative	30456 Participants	—
T0 (Baseline) DRE Screening Results Positive	2481 Participants	—
T0 (Baseline) DRE Screening Results Inadequate screen	1192 Participants	—

SECONDARY outcome

Timeframe: T1 (one year after entry)

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

Prostate-Specific Antigen (PSA) result.

Outcome measures

Measure	Control n=32688 Participants 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.
T1 PSA Screening Results Negative (<=4 ng/mL)	30159 Participants	—
T1 PSA Screening Results Positive (> 4 ng/mL)	2502 Participants	—
T1 PSA Screening Results Inadequate screen	27 Participants	—

SECONDARY outcome

Timeframe: T1 (one year after entry)

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

Digital Rectal Examination (DRE) result.

Outcome measures

Measure	Control n=32448 Participants 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.
T1 DRE Screening Results Negative	29311 Participants	—
T1 DRE Screening Results Positive	2237 Participants	—
T1 DRE Screening Results Inadequate screen	900 Participants	—

SECONDARY outcome

Timeframe: T2 (two years after entry)

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

Prostate-Specific Antigen (PSA) result.

Outcome measures

Measure	Control n=31691 Participants 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.
T2 PSA Screening Results Negative	29063 Participants	—
T2 PSA Screening Results Positive (> 4 ng/mL)	2593 Participants	—
T2 PSA Screening Results Inadequate screen	35 Participants	—

SECONDARY outcome

Timeframe: T2 (two years after entry)

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

Digital Rectal Examination (DRE) results

Outcome measures

Measure	Control n=31451 Participants 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.
T2 DRE Screening Results Negative	28391 Participants	—
T2 DRE Screening Results Positive	2327 Participants	—
T2 DRE Screening Results Inadequate screen	733 Participants	—

SECONDARY outcome

Timeframe: T3 (three years after entry)

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

Prostate-Specific Antigen (PSA) result

Outcome measures

Measure	Control n=30533 Participants 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.
T3 PSA Screening Results Negative (<=4 ng/mL)	27814 Participants	—
T3 PSA Screening Results Positive (> 4 ng/mL)	2676 Participants	—
T3 PSA Screening Results Inadequate screen	43 Participants	—

SECONDARY outcome

Timeframe: T3 (three years after entry)

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

Digital Rectal examination (DRE) result

Outcome measures

Measure	Control n=30244 Participants 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.
T3 DRE Screening Results Negative	27179 Participants	—
T3 DRE Screening Results Positive	2317 Participants	—
T3 DRE Screening Results Inadequate screen	748 Participants	—

SECONDARY outcome

Timeframe: T4 (four years after entry)

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

Prostate-Specific Antigen (PSA) result

Outcome measures

Measure	Control n=22170 Participants 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.
T4 PSA Screening Result Negative (<=4 ng/mL)	20362 Participants	—
T4 PSA Screening Result Positive (> 4 ng/mL)	1796 Participants	—
T4 PSA Screening Result Inadequate screen	12 Participants	—

SECONDARY outcome

Timeframe: T5 (five years after entry)

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

Prostate-Specific Antigen (PSA) result.

Outcome measures

Measure	Control n=25951 Participants 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.
T5 PSA Screening Results Negative (<=4 ng/mL)	23560 Participants	—
T5 PSA Screening Results Positive (> 4 ng/mL)	2377 Participants	—
T5 PSA Screening Results Inadequate screen	14 Participants	—

Adverse Events

Prostate Screening

Serious events: 0 serious events

Other events: 546 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Prostate Screening n=38340 participants at risk 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.
General disorders Anxiety	0.00% 1/38340 • Number of events 1 • During each annual screening visit. These events are solely those prompted by the screening examination.
General disorders Bleeding	0.01% 3/38340 • Number of events 3 • During each annual screening visit. These events are solely those prompted by the screening examination.
General disorders Dizzy	0.26% 101/38340 • Number of events 108 • During each annual screening visit. These events are solely those prompted by the screening examination.
General disorders Fainted	0.15% 58/38340 • Number of events 59 • During each annual screening visit. These events are solely those prompted by the screening examination.
General disorders Inflammation	0.01% 2/38340 • Number of events 2 • During each annual screening visit. These events are solely those prompted by the screening examination.
General disorders Nausea	0.00% 1/38340 • Number of events 1 • During each annual screening visit. These events are solely those prompted by the screening examination.
General disorders Pain	0.03% 11/38340 • Number of events 11 • During each annual screening visit. These events are solely those prompted by the screening examination.
General disorders Bruising	0.47% 182/38340 • Number of events 183 • During each annual screening visit. These events are solely those prompted by the screening examination.
General disorders Hematoma	0.49% 187/38340 • Number of events 190 • During each annual screening visit. These events are solely those prompted by the screening examination.

Additional Information

Paul F. Pinsky, Ph.D.

Early Detection Research Group, NCI, NIH

Phone: 301-496-8544

Email: pinskyp@mail.nih.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60