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Men at High Genetic Risk for Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03805919
Recruitment Status : Recruiting
First Posted : January 16, 2019
Last Update Posted : August 4, 2021
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Tracking Information
First Submitted Date January 15, 2019
First Posted Date January 16, 2019
Last Update Posted Date August 4, 2021
Actual Study Start Date March 27, 2019
Estimated Primary Completion Date January 1, 2029   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 3, 2021)
Natural history of high genetic risk for prostate cancer [ Time Frame: one year ]
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
Original Primary Outcome Measures
 (submitted: January 15, 2019)
Natural history of high genetic risk for prostate cancer [ Time Frame: one year ]
To follow the natural history of men with known germline variants or likely pathogenic variants in genes that put them at high risk fordeveloping prostate cancer
Change History
Current Secondary Outcome Measures
 (submitted: December 14, 2019)
  • mpMRI feasibility [ Time Frame: baseline and every two years until death or when criteria for removal from study is met ]
    test the feasibility and accuracy of multi parametric magnetic resonance imaging (mpMRI) for the localization and detection of local prostate cancer
  • role of mpMRI [ Time Frame: baseline and every two years until death or when criteria for removal from study is met ]
    role of mpMRI in monitoring participants on active surveillance and as a follow up tool for monitoring local disease progression
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Men at High Genetic Risk for Prostate Cancer
Official Title Natural History Study of Men at High Genetic Risk for Prostate Cancer
Brief 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:

Persons assigned male at birth 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.
Detailed Description

Background:

Prostate cancer is the most common malignancy and the second leading cause of cancer-related deaths in American men.

Prostate cancer has substantial inherited predisposition and certain genetic variants that are associated with an increased risk of prostate cancer.

An evolving approach to prostate cancer screening is to target populations at risk of developing prostate cancer based on their genetic predisposition.

Objective:

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

Eligibility:

Persons assigned male at birth who are between ages 30-75 years old.

Documented germline pathogenic or likely pathogenic variants in prostate cancer-related risk gene: BRCA 1 and 2, DNA Mismatch Repair (MMR) genes associated with Lynch syndrome (MLH1, MSH2, MSH6, PMS2, and EPCAM), HOXB13, ATM, NBN, TP53, CHEK2, PALB2, RAD51C, RAD51D, BRIP1, or FANC (FANCA, FANCB, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCI, FANCL, and FANCM).

Must be able and willing to provide informed consent.

Design:

Up to 500 subjects will be enrolled.

Participants will undergo sampling of blood for prostate-specific antigen. 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.

Following initial evaluation, participants will be followed as clinically indicated, usually at 12 month intervals, to determine their PSA level, prostate cancer treatment (if relevant) and/or disease/survival status until death.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Persons assigned male at birth with a documented germline variant in prostate cancer risk-related gene from a CLIA certified laboratory
Condition Prostatic Neoplasms
Intervention Not Provided
Study Groups/Cohorts Cohort 1
Participants with germline pathogenic or likely pathogenic variants in prostate cancer-related risk genes
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 15, 2019)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 1, 2039
Estimated Primary Completion Date January 1, 2029   (Final data collection date for primary outcome measure)
Eligibility Criteria
  • Inclusion Criteria:
  • Persons assigned male at birth between the ages of 30-75 years.
  • 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.
Sex/Gender
Sexes Eligible for Study: Male
Ages 30 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Anna C Couvillon, C.R.N.P. (240) 858-3148 couvilla@mail.nih.gov
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03805919
Other Study ID Numbers 190040
19-C-0040
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
Study Sponsor National Cancer Institute (NCI)
Collaborators Not Provided
Investigators
Principal Investigator: William L Dahut, M.D. National Cancer Institute (NCI)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date July 29, 2021