Prostate CarcinomaNCT00002540
Screening for Prostate Cancer in Older Patients (PLCO Screening Trial)
A study testing Laboratory Biomarker Analysis, Medical Examination Assessment and Screening Questionnaire Administration in people with Prostate Carcinoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 74 years, men only
- Conditions the study is for
- Prostate Carcinoma
- What is being tested?
- Laboratory Biomarker Analysis, Medical Examination Assessment and Screening Questionnaire Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76,685 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 1993to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 74 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial
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.
Read the 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.
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.
- Conditions
- Prostate Carcinoma
- Being tested
- Laboratory Biomarker Analysis, Medical Examination Assessment, Screening Questionnaire Administration
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory Biomarker AnalysisOther
Correlative studies
Medical Examination AssessmentProcedure or surgery
Also called Exam, Examination, Health Assessment, Health Examination
Undergo DRE
Screening Questionnaire AdministrationOther
Undergo questionnaire assessments
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants receive standard medical care. Participants complete a DHQ at baseline. |
| Prostate Screening | Active comparator | 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. Receives: Other: Laboratory Biomarker Analysis; Procedure: Medical Examination Assessment; Other: Screening Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prostate Cancer Deaths
Prostate cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate.
Measured: Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.
Prostate Cancer Death Rates
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.
Measured: Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.
Secondary outcomes (15)
Deaths From All Causes
Deaths from all causes were compared between the prostate cancer screening arm and the usual care arm.
Measured: Events through 13 years of follow-up or through December 31, 2009.
Death Rates From All Causes
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.
Measured: Events through 13 years of follow-up or through December 31, 2009.
Prostate Cancer Incidence
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.
Measured: Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.
Prostate Cancer Incidence Rates
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.
Measured: Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.
Complications of Diagnostic Evaluation (DE) Following a Positive Screening Test
Number of positive screens with complications
Measured: One year from screening examination
T0 (Baseline) PSA Screening Results
Prostate-Specific Antigen (PSA) result.
Measured: T0 (at study entry)
T0 (Baseline) DRE Screening Results
Digital Rectal Examination (DRE) result.
Measured: T0 (at study entry)
T1 PSA Screening Results
Prostate-Specific Antigen (PSA) result.
Measured: T1 (one year after entry)
T1 DRE Screening Results
Digital Rectal Examination (DRE) result.
Measured: T1 (one year after entry)
T2 PSA Screening Results
Prostate-Specific Antigen (PSA) result.
Measured: T2 (two years after entry)
T2 DRE Screening Results
Digital Rectal Examination (DRE) results
Measured: T2 (two years after entry)
T3 PSA Screening Results
Prostate-Specific Antigen (PSA) result
Measured: T3 (three years after entry)
T3 DRE Screening Results
Digital Rectal examination (DRE) result
Measured: T3 (three years after entry)
T4 PSA Screening Result
Prostate-Specific Antigen (PSA) result
Measured: T4 (four years after entry)
T5 PSA Screening Results
Prostate-Specific Antigen (PSA) result.
Measured: T5 (five years after entry)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2004 (estimated)
- Study start16 Nov 1993
- Primary completion21 May 2012
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Prostate CarcinomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 76,685 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Christine D Berg, Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002540
- Sponsor's protocol ID
- NCI-2012-01755
- Other IDs
- NCI-2012-01755, CDR0000078532, NCI-P93-0050, PLCO-1, PLCO-Prostate
- Status last verified
- Jul 2026
- First submitted
- 1 Nov 1999
- Last updated
- 24 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Malcomson 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.
PubMed 41261199Fan 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.
PubMed 38741776Jiang 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.
PubMed 34548240Pinsky 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.
PubMed 33691305Wang 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.
PubMed 33277073Pinsky 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.
PubMed 30943843Pierre-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.
PubMed 30592477Miller EA, Pinsky PF, Schoen RE, Prorok PC, Church TR. Effect of flexible sigmoidoscopy screening on colorectal cancer incidence and mortality: long-term follow-up of the randomised US PLCO cancer screening trial. Lancet Gastroenterol Hepatol. 2019 Feb;4(2):101-110. doi: 10.1016/S2468-1253(18)30358-3. Epub 2018 Nov 29.
PubMed 30502933Click B, Pinsky PF, Hickey T, Doroudi M, Schoen RE. Association of Colonoscopy Adenoma Findings With Long-term Colorectal Cancer Incidence. JAMA. 2018 May 15;319(19):2021-2031. doi: 10.1001/jama.2018.5809.
PubMed 29800214Schoen RE, Razzak A, Yu KJ, Berndt SI, Firl K, Riley TL, Pinsky PF. Incidence and mortality of colorectal cancer in individuals with a family history of colorectal cancer. Gastroenterology. 2015 Nov;149(6):1438-1445.e1. doi: 10.1053/j.gastro.2015.07.055. Epub 2015 Aug 5.
PubMed 26255045Guertin KA, Loftfield E, Boca SM, Sampson JN, Moore SC, Xiao Q, Huang WY, Xiong X, Freedman ND, Cross AJ, Sinha R. Serum biomarkers of habitual coffee consumption may provide insight into the mechanism underlying the association between coffee consumption and colorectal cancer. Am J Clin Nutr. 2015 May;101(5):1000-11. doi: 10.3945/ajcn.114.096099. Epub 2015 Mar 11.
PubMed 25762808Kvale PA, Johnson CC, Tammemagi M, Marcus PM, Zylak CJ, Spizarny DL, Hocking W, Oken M, Commins J, Ragard L, Hu P, Berg C, Prorok P. Interval lung cancers not detected on screening chest X-rays: How are they different? Lung Cancer. 2014 Oct;86(1):41-6. doi: 10.1016/j.lungcan.2014.07.013. Epub 2014 Jul 24.
PubMed 25123333Guertin KA, Moore SC, Sampson JN, Huang WY, Xiao Q, Stolzenberg-Solomon RZ, Sinha R, Cross AJ. Metabolomics in nutritional epidemiology: identifying metabolites associated with diet and quantifying their potential to uncover diet-disease relations in populations. Am J Clin Nutr. 2014 Jul;100(1):208-17. doi: 10.3945/ajcn.113.078758. Epub 2014 Apr 16.
PubMed 24740205Major JM, Yu K, Weinstein SJ, Berndt SI, Hyland PL, Yeager M, Chanock S, Albanes D. Genetic variants reflecting higher vitamin e status in men are associated with reduced risk of prostate cancer. J Nutr. 2014 May;144(5):729-33. doi: 10.3945/jn.113.189928. Epub 2014 Mar 12.
PubMed 24623848Hocking WG, Tammemagi MC, Commins J, Oken MM, Kvale PA, Hu P, Ragard LR, Riley TL, Pinsky P, Beck TM, Prorok PC. Diagnostic evaluation following a positive lung screening chest radiograph in the Prostate, Lung, Colorectal, Ovarian (PLCO) Cancer Screening Trial. Lung Cancer. 2013 Nov;82(2):238-44. doi: 10.1016/j.lungcan.2013.07.017. Epub 2013 Aug 7.
PubMed 23993734
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial
- ClinicalTrials.gov ID
- NCT00002540
- Acronym / sponsor ID
- NCI-2012-01755
- Conditions
- Prostate Carcinoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 76,685 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 16 Nov 1993 (actual)
- Primary completion
- 21 May 2012 (actual)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 26 Mar 2004 (estimated)
- Results
- Posted 26 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants receive standard medical care. Participants complete a DHQ at baseline. |
| Prostate Screening | Active comparator | Other: Laboratory Biomarker Analysis, Procedure: Medical Examination Assessment, Other: Screening Questionnaire AdministrationParticipants 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. |
Who may qualify
- Ages
- 55 to 74 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (12 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory Biomarker AnalysisCorrelative studies | Other | Prostate Screening |
| Medical Examination AssessmentAlso: Exam, Examination, Health Assessment, Health ExaminationUndergo DRE | Procedure or surgery | Prostate Screening |
| Screening Questionnaire AdministrationUndergo questionnaire assessments | Other | Prostate Screening |
Primary outcome
Prostate Cancer Deaths
Time frame: 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
Time frame: 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.
15 secondary outcomes
Deaths From All Causes
Time frame: Events through 13 years of follow-up or through December 31, 2009.
Death Rates From All Causes
Time frame: Events through 13 years of follow-up or through December 31, 2009.
Prostate Cancer Incidence
Time frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.
Prostate Cancer Incidence Rates
Time frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.
Complications of Diagnostic Evaluation (DE) Following a Positive Screening Test
Time frame: One year from screening examination
T0 (Baseline) PSA Screening Results
Time frame: T0 (at study entry)
T0 (Baseline) DRE Screening Results
Time frame: T0 (at study entry)
T1 PSA Screening Results
Time frame: T1 (one year after entry)
T1 DRE Screening Results
Time frame: T1 (one year after entry)
T2 PSA Screening Results
Time frame: T2 (two years after entry)
T2 DRE Screening Results
Time frame: T2 (two years after entry)
T3 PSA Screening Results
Time frame: T3 (three years after entry)
T3 DRE Screening Results
Time frame: T3 (three years after entry)
T4 PSA Screening Result
Time frame: T4 (four years after entry)
T5 PSA Screening Results
Time frame: T5 (five years after entry)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41261199Malcomson 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.
- Derived from this study: PubMed 38741776Fan 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.
- Derived from this study: PubMed 34548240Jiang 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.
- Derived from this study: PubMed 33691305Pinsky 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.
- Derived from this study: PubMed 33277073Wang 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.
- Derived from this study: PubMed 30943843Pinsky 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.
- Derived from this study: PubMed 30592477Pierre-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.
- Derived from this study: PubMed 30502933Miller EA, Pinsky PF, Schoen RE, Prorok PC, Church TR. Effect of flexible sigmoidoscopy screening on colorectal cancer incidence and mortality: long-term follow-up of the randomised US PLCO cancer screening trial. Lancet Gastroenterol Hepatol. 2019 Feb;4(2):101-110. doi: 10.1016/S2468-1253(18)30358-3. Epub 2018 Nov 29.
- Derived from this study: PubMed 29800214Click B, Pinsky PF, Hickey T, Doroudi M, Schoen RE. Association of Colonoscopy Adenoma Findings With Long-term Colorectal Cancer Incidence. JAMA. 2018 May 15;319(19):2021-2031. doi: 10.1001/jama.2018.5809.
- Derived from this study: PubMed 26255045Schoen RE, Razzak A, Yu KJ, Berndt SI, Firl K, Riley TL, Pinsky PF. Incidence and mortality of colorectal cancer in individuals with a family history of colorectal cancer. Gastroenterology. 2015 Nov;149(6):1438-1445.e1. doi: 10.1053/j.gastro.2015.07.055. Epub 2015 Aug 5.
- Derived from this study: PubMed 25762808Guertin KA, Loftfield E, Boca SM, Sampson JN, Moore SC, Xiao Q, Huang WY, Xiong X, Freedman ND, Cross AJ, Sinha R. Serum biomarkers of habitual coffee consumption may provide insight into the mechanism underlying the association between coffee consumption and colorectal cancer. Am J Clin Nutr. 2015 May;101(5):1000-11. doi: 10.3945/ajcn.114.096099. Epub 2015 Mar 11.
- Derived from this study: PubMed 25123333Kvale PA, Johnson CC, Tammemagi M, Marcus PM, Zylak CJ, Spizarny DL, Hocking W, Oken M, Commins J, Ragard L, Hu P, Berg C, Prorok P. Interval lung cancers not detected on screening chest X-rays: How are they different? Lung Cancer. 2014 Oct;86(1):41-6. doi: 10.1016/j.lungcan.2014.07.013. Epub 2014 Jul 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine D Berg principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laboratory Biomarker Analysis, Medical Examination Assessment and Screening Questionnaire Administration in people with Prostate Carcinoma, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prostate Cancer Deaths (time frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00002540, which also lists 29 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.