Cancer Screening Methods for Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores various screening methods to determine their effectiveness in catching prostate cancer early and reducing mortality. Through blood sample analysis (Laboratory Biomarker Analysis) and questionnaires, researchers aim to identify the best early detection strategies. Men aged 55 to 75 who have not undergone major cancer surgeries or specific cancer treatments are suitable candidates for this trial. Participants will either receive standard care or undergo regular screenings and tests over several years. As an unphased trial, this study allows participants to contribute to significant research that could enhance early detection methods for prostate cancer.
Do I need to stop my current medications for the trial?
The trial does not specify that you need to stop taking your current medications. However, if you are taking Proscar, Propecia, or finasteride, you should not have taken them in the past 6 months before joining the trial. If you are already in the trial and your doctor prescribes finasteride, you can continue taking it.
What prior data suggests that these cancer screening methods are safe?
Research has shown that prostate cancer screening methods, such as the PSA (Prostate-Specific Antigen) test and digital rectal exams (DRE), have mixed results regarding safety and effectiveness. Studies indicate that PSA screening can reduce prostate cancer deaths by up to 31%. However, about 6%–7% of men may experience false-positive results during any screening round, leading to unnecessary worry and additional tests.
The DRE, often used alongside the PSA test, is less effective on its own, detecting prostate cancer less frequently than the PSA test. Additionally, both screening methods can result in overdiagnosis, identifying cancers that may not cause harm during a person's lifetime.
Screening questionnaires also play a role in the process by gathering important information about a person's risk factors and awareness. However, they can cause anxiety due to false positives.
Overall, these screening methods are generally safe but carry some risks, particularly the chance of false positives and overdiagnosis.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores innovative ways to improve prostate cancer screening. Unlike current methods, which often rely on PSA tests and digital rectal exams alone, this study uses a combination of lab biomarker analysis, detailed medical exams, and extensive questionnaires to gather comprehensive data over several years. This approach could enhance early detection by identifying new biomarkers and patterns in patient health data, potentially leading to more accurate and personalized screening strategies. By following participants over a long period, the trial aims to uncover valuable insights into the progression and early signs of prostate cancer, which could revolutionize how we screen for this condition in the future.
What evidence suggests that these screening methods are effective for reducing deaths from prostate cancer?
This trial will compare different methods of prostate cancer screening. Studies have shown that using the Prostate-Specific Antigen (PSA) test for screening has significantly reduced the number of men diagnosed with advanced stages of the disease. Before PSA testing became common, 32% of new prostate cancer cases were advanced, but now it's about 9%. This screening method has also led to fewer deaths from prostate cancer. For instance, screening can prevent one to two deaths for every 1,000 men tested. Additionally, areas with more frequent PSA testing have experienced a 17% drop in deaths specifically from prostate cancer. These findings suggest that regular prostate cancer screening effectively reduces the severity of the disease and its mortality rate.12678
Who Is on the Research Team?
Christine D Berg
Principal Investigator
National Cancer Institute (NCI)
Are You a Good Fit for This Trial?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Prostate Screening
Participants undergo blood sample collection for PSA analysis and digital rectal examination (DRE) at baseline and annually for 3-5 years
Follow-up
Participants are monitored for prostate cancer incidence and mortality, with annual updates for 13 years
What Are the Treatments Tested in This Trial?
Interventions
- Laboratory Biomarker Analysis
- Medical Examination
- Screening Questionnaire Administration
Laboratory Biomarker Analysis is already approved in United States, European Union for the following indications:
- Mantle cell lymphoma
- Chronic lymphocytic leukemia/small lymphocytic lymphoma
- Waldenström's macroglobulinemia
- Marginal zone lymphoma
- Chronic graft-versus-host disease
- Mantle cell lymphoma
- Chronic lymphocytic leukemia/small lymphocytic lymphoma
- Waldenström's macroglobulinemia
- Marginal zone lymphoma
- Chronic graft-versus-host disease
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor