Clinical trial · Interventional
Screening for Prostate Cancer in Older Patients (PLCO Screening Trial)
Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial
NCT00002540CI-TRIAL-00119334active not recruitingN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Carcinoma | Prostate Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Medical Examination Assessment | Procedure | — | UNRESOLVED |
| Screening Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control
- description
- Participants receive standard medical care. Participants complete a DHQ at baseline.
- type
- ACTIVE_COMPARATOR
- label
- Prostate Screening
- description
- 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.
- interventionNames
- Other: Laboratory Biomarker Analysis
- Procedure: Medical Examination Assessment
- Other: Screening Questionnaire Administration
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 55 Years
- Maximum age
- 74 Years
Show eligibility criteria text
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
References
Publications (29)
- DERIVEDMalcomson FC, Shams-White MM, Reedy J, Huang WY, Moore SC, Loftfield E. Adherence to the 2018 World Cancer Research Fund/American Institute for Cancer Research Cancer Prevention Recommendations and risk of lifestyle-related cancers in the prostate, lung, colorectal, and ovarian cancer screening trial. BJC Rep. 2025 Nov 19;3(1):81. doi: 10.1038/s44276-025-00195-6. PMID 41261199
- DERIVEDFan Z, Zhang Y, Yao Q, Liu X, Duan H, Liu Y, Sheng C, Lyu Z, Yang L, Song F, Huang Y, Song F. Effects of joint screening for prostate, lung, colorectal, and ovarian cancer - results from a controlled trial. Front Oncol. 2024 Apr 29;14:1322044. doi: 10.3389/fonc.2024.1322044. eCollection 2024. PMID 38741776
- DERIVEDJiang Y, Xie Q, Chen R. Breast Cancer Incidence and Mortality in Relation to Hormone Replacement Therapy Use Among Postmenopausal Women: Results From a Prospective Cohort Study. Clin Breast Cancer. 2022 Feb;22(2):e206-e213. doi: 10.1016/j.clbc.2021.06.010. Epub 2021 Jun 26. PMID 34548240
- DERIVEDPinsky PF, Durham D, Strassels S. Opioid and Other Medication Use and General Health Status in a Cohort of Older Adults. Gerontology. 2021;67(5):554-562. doi: 10.1159/000513731. Epub 2021 Mar 10. PMID 33691305
- DERIVEDWang K, Wu Q, Li Z, Reger MK, Xiong Y, Zhong G, Li Q, Zhang X, Li H, Foukakis T, Xiang T, Zhang J, Ren G. Vitamin K intake and breast cancer incidence and death: results from a prospective cohort study. Clin Nutr. 2021 May;40(5):3370-3378. doi: 10.1016/j.clnu.2020.11.009. Epub 2020 Nov 16. PMID 33277073
- DERIVEDPinsky PF, Miller EA, Zhu CS, Prorok PC. Overall mortality in men and women in the randomized Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial. J Med Screen. 2019 Sep;26(3):127-134. doi: 10.1177/0969141319839097. Epub 2019 Apr 3. No abstract available. PMID 30943843
- Pierre-Victor D, Pinsky PF. Association of Nonadherence to Cancer Screening Examinations With Mortality From Unrelated Causes: A Secondary Analysis of the PLCO Cancer Screening Trial. JAMA Intern Med. 2019 Feb 1;179(2):196-203. doi: 10.1001/jamainternmed.2018.5982.