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Men at High Genetic Risk for Prostate Cancer

Natural History Study of Men at High Genetic Risk for Prostate Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
30 Years to 75 Years
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Biopsies, MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Based on these results and age, participants will be considered for biopsy and/or continued monitoring if feasible upon clinical discretion."
  • "Participants will undergo a baseline MRI evaluation with follow-up scans every 2 years as clinically indicated."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study follows prostate health in men ages 30–75 who have certain inherited gene changes and have not had prostate cancer. Researchers want to learn how gene changes and family history affect prostate cancer risk and may help guide prevention or treatment. The study does not provide genetic testing.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are male and 30–75 years old.
  • You have an inherited gene change known or likely to raise prostate cancer risk in one of the genes listed by the study.
  • You can provide a report of that gene change from a CLIA-certified lab, a lab that meets federal testing standards.
  • If you have another cancer, you are expected to live more than 5 years.
  • You can understand the study and are willing to sign a consent form.

Who can't join

  • You have been diagnosed with or treated for prostate cancer.
  • You cannot fit in the MRI scanner, which uses magnets to take pictures inside the body.
  • You are allergic to the dye used for MRI scans.
  • You have a pacemaker, a clip used to treat a bulging blood vessel in the brain, a shrapnel injury, or an implanted electronic device.
  • You have a current physical or mental health condition that the study doctor believes could make the study unsafe or keep you from giving informed consent.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

* Inclusion Criteria: * Males between ages 30-75 years old. * Documented germline variant (i.e. pathogenic/likely pathogenic variant) in prostate cancer risk-related gene from a CLIA certified laboratory: BRCA1 and BRCA2, MMR genes (MLH1, MSH2, MSH6, PMS2, and EPCAM) associated with Lynch syndrome, as well as HOXB13, ATM, NBN, TP53, CHEK2, PALB2, RAD51C, RAD51D, BRIP1, or FANC (FANCA, FANCB, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCI, FANCL, and FANCM). * Prognosis of \>5 years survival if affected by another cancer * Ability of subject to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Prior diagnosis or treatment for prostate cancer * Known contraindication to MRI: * Participants unable to fit through MRI scanner (radiologist discretion) * Allergy to MR contrast agent * Participants with pacemakers, cerebral aneurysm clips, shrapnel injury, or implantable electronic device * Active concomitant medical or psychological illnesses that may increase the risk to the subject or inability to obtain informed consent, at the discretion of the principal investigator.

Study sites (1)

MD