Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 76,685
- 试验地点
- 1
- 主要终点
- Prostate Cancer Death Rates
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 55 Years 至 74 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Control
Participants receive standard medical care. Participants complete a DHQ at baseline.
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.
干预措施: Screening Questionnaire Administration (Other)
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.
干预措施: Laboratory Biomarker Analysis (Other)
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.
干预措施: Medical Examination Assessment (Procedure)
结局指标
主要结局
Prostate Cancer Death Rates
时间窗: 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.
Prostate Cancer Deaths
时间窗: 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.
次要结局
- T2 DRE Screening Results(T2 (two years after entry))
- Prostate Cancer Incidence Rates(Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.)
- T1 PSA Screening Results(T1 (one year after entry))
- Deaths From All Causes(Events through 13 years of follow-up or through December 31, 2009.)
- T1 DRE Screening Results(T1 (one year after entry))
- T5 PSA Screening Results(T5 (five years after entry))
- Prostate Cancer Incidence(Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.)
- T2 PSA Screening Results(T2 (two years after entry))
- T3 DRE Screening Results(T3 (three years after entry))
- T4 PSA Screening Result(T4 (four years after entry))
- Death Rates From All Causes(Events through 13 years of follow-up or through December 31, 2009.)
- Complications of Diagnostic Evaluation (DE) Following a Positive Screening Test(One year from screening examination)
- T0 (Baseline) PSA Screening Results(T0 (at study entry))
- T0 (Baseline) DRE Screening Results(T0 (at study entry))
- T3 PSA Screening Results(T3 (three years after entry))