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

Brief summary public domain (ClinicalTrials.gov)

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.

Detailed description public domain (ClinicalTrials.gov)

PRIMARY OBJECTIVES: I. 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: I. To assess screening variables, other than mortality, for each of the interventions including sensitivity, specificity, and positive predictive value. II. 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. IV. 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.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Prostate Cancer Deaths [Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.]. Number, Participants. Control (n=38345): 145; Prostate Screening (n=38340): 158. Analysis, Control vs Prostate Screening: Hazard Ratio (HR) 1.09 (95% CI 0.87 to 1.36); Poisson regression; superiority or other legacy.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Deaths From All Causes [Events through 13 years of follow-up or through December 31, 2009.]. Number, Participants. Control (n=38345): 7089; Prostate Screening (n=38340): 6855.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Death Rates From All Causes [Events through 13 years of follow-up or through December 31, 2009.]. Number, Deaths per 10,000 PY. Control (n=38345): 166.6; Prostate Screening (n=38340): 160.5. Analysis, Control vs Prostate Screening: Hazard Ratio (HR) 0.96 (95% CI 0.93 to 1.00); Poisson regression; superiority or other legacy.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Prostate Cancer Incidence [Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.]. Number, Participants. Control (n=38345): 3815; Prostate Screening (n=38340): 4250.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Prostate Cancer Incidence Rates [Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.]. Number, Diagnoses per 10,000 PY. Control (n=38345): 97.1; Prostate Screening (n=38340): 108.4. Analysis, Control vs Prostate Screening: Hazard Ratio (HR) 1.12 (95% CI 1.07 to 1.17); Poisson regression; superiority or other legacy.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Complications of Diagnostic Evaluation (DE) Following a Positive Screening Test [One year from screening examination]. Number, Positive screens w/ complications. When DE Led to Prostate Cancer Diagnosis: Prostate Screening (n=10642): 901. When DE Did Not Lead to Prostate Cancer Diagnosis: Prostate Screening (n=10642): 124.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

T0 (Baseline) PSA Screening Results [T0 (at study entry)]. Number, Participants. Negative (<=4 ng/mL): Prostate Screening (n=34247): 31507. Positive (> 4 ng/mL): Prostate Screening (n=34247): 2718. Inadequate screen: Prostate Screening (n=34247): 22.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

T0 (Baseline) DRE Screening Results [T0 (at study entry)]. Number, Participants. Negative: Prostate Screening (n=34129): 30456. Positive: Prostate Screening (n=34129): 2481. Inadequate screen: Prostate Screening (n=34129): 1192.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

T1 PSA Screening Results [T1 (one year after entry)]. Number, Participants. Negative (<=4 ng/mL): Prostate Screening (n=32688): 30159. Positive (> 4 ng/mL): Prostate Screening (n=32688): 2502. Inadequate screen: Prostate Screening (n=32688): 27.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

T1 DRE Screening Results [T1 (one year after entry)]. Number, Participants. Negative: Prostate Screening (n=32448): 29311. Positive: Prostate Screening (n=32448): 2237. Inadequate screen: Prostate Screening (n=32448): 900.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

T2 PSA Screening Results [T2 (two years after entry)]. Number, Participants. Negative: Prostate Screening (n=31691): 29063. Positive (> 4 ng/mL): Prostate Screening (n=31691): 2593. Inadequate screen: Prostate Screening (n=31691): 35.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

T2 DRE Screening Results [T2 (two years after entry)]. Number, Participants. Negative: Prostate Screening (n=31451): 28391. Positive: Prostate Screening (n=31451): 2327. Inadequate screen: Prostate Screening (n=31451): 733.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

T3 PSA Screening Results [T3 (three years after entry)]. Number, Participants. Negative (<=4 ng/mL): Prostate Screening (n=30533): 27814. Positive (> 4 ng/mL): Prostate Screening (n=30533): 2676. Inadequate screen: Prostate Screening (n=30533): 43.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

T3 DRE Screening Results [T3 (three years after entry)]. Number, Participants. Negative: Prostate Screening (n=30244): 27179. Positive: Prostate Screening (n=30244): 2317. Inadequate screen: Prostate Screening (n=30244): 748.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Prostate Cancer Death Rates [Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.]. Number, Deaths per 10,000 PY. Control (n=38345): 3.4; Prostate Screening (n=38340): 3.7. Analysis, Control vs Prostate Screening: Hazard Ratio (HR) 1.09 (95% CI 0.87 to 1.36); Poisson regression; superiority or other legacy.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

T4 PSA Screening Result [T4 (four years after entry)]. Number, Participants. Negative (<=4 ng/mL): Prostate Screening (n=22170): 20362. Positive (> 4 ng/mL): Prostate Screening (n=22170): 1796. Inadequate screen: Prostate Screening (n=22170): 12.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

T5 PSA Screening Results [T5 (five years after entry)]. Number, Participants. Negative (<=4 ng/mL): Prostate Screening (n=25951): 23560. Positive (> 4 ng/mL): Prostate Screening (n=25951): 2377. Inadequate screen: Prostate Screening (n=25951): 14.