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Cancer Screening Methods for Prostate Cancer
N/A
Waitlist Available
Led By Christine D Berg
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up events through 13 years of follow-up or through december 31, 2009; median follow-up 12.0 years.
Awards & highlights
Study Summary
This trial looks at different ways of screening for common cancers to see if any of them can reduce the number of people who die from these cancers.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves non-invasive screening procedures rather than medication or surgery, side effects are minimal but may include discomfort from medical examinations or anxiety from test results.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man under 55 or over 75 years old.
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I am currently being treated for cancer, not including basal or squamous skin cancer.
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I have had cancer of the colon, rectum, lung, or prostate before.
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I have had surgery to remove my entire colon, one lung, or my entire prostate.
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I have taken Proscar, Propecia, or finasteride in the last 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ events through 13 years of follow-up or through december 31, 2009; median follow-up 12.0 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~events through 13 years of follow-up or through december 31, 2009; median follow-up 12.0 years.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Prostate Cancer Death Rates
Prostate Cancer Deaths
Secondary outcome measures
Complications of Diagnostic Evaluation (DE) Following a Positive Screening Test
Death Rates From All Causes
Deaths From All Causes
+12 moreTrial Design
2Treatment groups
Active Control
Group I: ControlActive Control1 Intervention
Participants receive standard medical care. Participants complete a DHQ at baseline.
Group II: Prostate ScreeningActive Control3 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.
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Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,687 Previous Clinical Trials
40,853,686 Total Patients Enrolled
563 Trials studying Prostate Cancer
432,151 Patients Enrolled for Prostate Cancer
Christine D BergPrincipal InvestigatorNational Cancer Institute (NCI)
3 Previous Clinical Trials
388,017 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility 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.You are already participating in another study focused on preventing or screening for cancer.I am a man taking Tamoxifen and can participate in all parts of the trial.My cancer is either original or has spread from the original site.I am a male who has had multiple PSA tests in the last 3 years.I am currently being treated for cancer, not including basal or squamous skin cancer.I have had a colonoscopy, sigmoidoscopy, or barium enema within the last 3 years.I have had cancer of the colon, rectum, lung, or prostate before.I have had surgery to remove my entire colon, one lung, or my entire prostate.I have taken Proscar, Propecia, or finasteride in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Prostate Screening
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings left in this research initiative?
"According to clinicaltrials.gov, this trial is no longer taking new patients; the study was initially posted on November 16th 1993 and most recently updated June 30th 2022. Nonetheless, there are 1321 other trials actively recruiting participants at the present moment."
Answered by AI
For whom is this medical study best suited?
"This prostate cancer clinical trial is in need of 76685 participants aged between 55 and 74. To be eligible, candidates must meet these relevant criteria."
Answered by AI
Is this investigation open to individuals aged 40 or older?
"This clinical research stipulates that only those aged between 55 and 74 are eligible to apply. For younger people, there are 76 studies available while 1315 trials cater for senior citizens."
Answered by AI
What are the main goals of this experiment?
"This clinical trial will track [Prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) Deaths over a 13 year period, with an approximate median follow-up of 12 years. Secondary outcomes include Prostate Cancer Incidence Rates, T2 PSA Screening Results and T5 PSA Screening Results. These results are defined as the diagnoses confirmed by medical record abstraction divided by person years at risk for prostate cancer; or the Prostate Specific Antigen (PSA) result respectively."
Answered by AI
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