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NCT03805919 · ClinicalTrials.gov registry record

Men at High Genetic Risk for Prostate Cancer

A clinical trial of Prostatic Neoplasms, sponsored by National Cancer Institute (NCI).

Recruiting
Registry status
500
Enrollment target
1
Study location

NCT03805919: Recruiting study of Prostatic Neoplasms, sponsored by National Cancer Institute (NCI).

NCT03805919 is a study of Prostatic Neoplasms that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 500 participants, roughly in line with the 507-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03805919, a study of Prostatic Neoplasms, is actively recruiting participants, sponsored by National Cancer Institute (NCI).

RECRUITING
Registry status
500 participants
Enrollment target
1
Study location

Study Summary

Background: Research studies have shown that genetic changes and family history may increase a man s risk for prostate cancer. Researchers want to follow the prostate health of men who have specific genetic changes associated with prostate cancer to help them learn more about which men are at higher risk for prostate cancer. Objectives: To study men with specific genetic changes and determine who is at higher risk for getting prostate cancer. To study if certain genetic changes and family history can be used to help prevent or treat prostate cancer. Eligibility: Males between ages 30-75 who have one or more specific genetic changes but without prostate cancer. Design: * This study does not perform genetic testing. All participants must have documented genetic changes and able to provide a copy of the report. * Before enrollment, participants will provide a copy of documented genetic changes and go through a telephone interview to determine eligibility for the study. * On enrollment, participants will have medical and family history review, medication review, physical exam, blood collection for clinical and research testing, and MRI (magnetic resonance imaging) of the prostate. * Every year, participants will repeat the physical exam, medical history, family history, medication review, routine blood tests, including PSA and testosterone. * Every 2 years, participants will repeat all the above plus prostate MRI and blood tests for research. * If, at any time, the physical exam, blood tests or MRI are abnormal, participants may be asked to do a biopsy. * If the biopsy results in prostate cancer, participants will be given counseling on next steps, general treatment recommendations, and then followed with a phone call each year. * Participants may ask to speak with a genetic counselor.

Primary Outcome

To follow the natural history of men with known germline variants or likely pathogenic variants in genes that put them at high risk for developing prostate cancer

Conditions Studied

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 500 participants
Start Date 2019-03-27
Est. Completion 2039-01-01
National Cancer Institute (NCI)

3,257 total trials

What NCT03805919 shows while recruiting

NCT03805919 is an observational study that tracks outcomes without assigning an intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 507-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target.

The record links to 1 condition, with Prostatic Neoplasms appearing as the primary indexed condition, and to 0 interventions.

NCT03805919 reports a single indexed study location in Maryland.

Frequently Asked Questions

What is clinical trial NCT03805919 about?

NCT03805919 is a clinical study titled "Men at High Genetic Risk for Prostate Cancer". Background: Research studies have shown that genetic changes and family history may increase a man s risk for prostate cancer. Researchers want to follow the prostate health of men who have specific genetic changes associated with prostate cancer to help them learn more about which men are at highe...

What is the current status of trial NCT03805919?

This trial is currently recruiting. The enrollment target is 500 participants. The study started on 2019-03-27. Estimated completion is 2039-01-01.

What conditions does trial NCT03805919 study?

This clinical trial studies the following conditions: Prostatic Neoplasms.

Who is sponsoring clinical trial NCT03805919?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03805919 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Prostatic Neoplasms

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03805919's enrollment target sits among peer trials

500 25th of 65 higher than 41 of 65 other Prostatic Neoplasms trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Prostatic Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03805919, the US trial registry maintained by the National Library of Medicine. NCT03805919 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.