Cancer Screening Methods for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: National Cancer Institute (NCI)

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

76685 Participants Needed

Trial Summary

What is the purpose of this 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.

Research Team

Christine D Berg

Principal Investigator

National Cancer Institute (NCI)

Eligibility Criteria

This trial is for men aged below 55 or above 75, who haven't used Proscar/Propecia/finasteride in the last 6 months. It's not for those with prior cancers (except certain skin cancers), recent colon cancer screenings, major organ removals due to cancer, or current participation in other cancer trials. Men must be willing to sign consent and have had no more than one PSA test in three years.

Inclusion Criteria

I am willing and able to sign the informed consent form.

I am a man under 55 or over 75 years old.

I can stay in the trial if I start taking finasteride after enrollment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prostate Screening

Participants undergo blood sample collection for PSA analysis and digital rectal examination (DRE) at baseline and annually for 3-5 years

5 years

Annual visits for 5 years

Follow-up

Participants are monitored for prostate cancer incidence and mortality, with annual updates for 13 years

13 years

Annual follow-up via mailed questionnaire

Treatment Details

Interventions

• Laboratory Biomarker Analysis
• Medical Examination
• Screening Questionnaire Administration

Trial Overview The study tests if screening methods like questionnaires, lab biomarker analysis, and medical exams can help detect prostate cancer early and reduce death rates. The focus is on finding better ways to identify prostate cancer at an early stage through various screening techniques.

Participant Groups

Group I: Control Active Control 1 Intervention

Participants receive standard medical care. Participants complete a DHQ at baseline.

Group II: Prostate Screening Active Control 3 Interventions

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.

Laboratory Biomarker Analysis is already approved in United States, European Union for the following indications:

Approved in United States as Imbruvica for:

• Mantle cell lymphoma
• Chronic lymphocytic leukemia/small lymphocytic lymphoma
• Waldenström's macroglobulinemia
• Marginal zone lymphoma
• Chronic graft-versus-host disease

Approved in European Union as Imbruvica for:

• Mantle cell lymphoma
• Chronic lymphocytic leukemia/small lymphocytic lymphoma
• Waldenström's macroglobulinemia
• Marginal zone lymphoma
• Chronic graft-versus-host disease

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+