ClinicalTrials.gg
CompletedNCT04015102Updated Nov 5, 2020

A Registry for Hereditary Cancer Risk Assessment and Genetic Testing

An observational study in Prostate Cancer, sponsored by Myriad Genetic Laboratories, Inc.. Completed at 10 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-05.

Sponsored by Myriad Genetic Laboratories, Inc. · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
255
Ages
18 Years and older
Sex
Male
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 3,595 studies in Prostatic Neoplasms with a site in United States — 607 open to participants now, 977 under way, 101 of them phase 3. Prostatic Neoplasms · United States.

Enrollment
191st of 477
255 · median 157
Started
2019
with 159 others
Observational
482 of 3,595
99 open now
Registered
2,409th of 3,595
by date

Among the 3,595 studies in Prostatic Neoplasms with a site in United States, this one is the 191st largest by enrollment of the 477 observational ones that give a count, is one of 160 that started in 2019, is one of 482 observational ones, and was the 2,409th registered.

Prostatic Neoplasms

7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,579 are open to participants now.

Browse Prostatic Neoplasms studies →

Open to participants now

607 of the 3,595 studies in Prostatic Neoplasms with a site in United States are open now. Recruiting first, the newest first:

602 more — sign in →

All 607 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 1,228 Prostatic Neoplasms studies recruiting now, 927 (75%) set no upper age limit and 76 (6%) stop at 75 or younger; 67 take children under 18; 82 take healthy volunteers.

This study: 18 Years and older · male · no healthy volunteers.

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02

Study summary

This prospective registry will evaluate the feasibility and impact of implementing standard cancer family history review and guideline-aligned genetic testing for men diagnosed with Prostate Cancer in community urology practices nationwide.

Read the detailed description

Genes linked to hereditary cancer syndromes have been associated with increased risk for prostate cancer (PrCa), earlier disease onset and increased disease aggressiveness.1,2 Ascertaining family cancer history and hereditary risk in men diagnosed with PrCa can help inform medical management decisions. Recently published National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Prostate Cancer (v3.2018)3 and Genetic/Familial High Risk Assessment: Breast and Ovarian (v2.2019)4 as well as the American Urological Association Guideline for Clinically Localized Prostate Cancer (2017)5 recommend appropriate counseling and genetic testing for men who are at increased hereditary cancer risk, based upon personal or family history. Genetic testing for patients with metastatic prostate cancer is now standard of care per NCCN Genetic/Familial High Risk Assessment: Breast and Ovarian (v2.2019) guidelines4. NCCN Prostate Cancer Guidelines (v3.2018)3 recommend obtaining a cancer-focused family history at diagnosis and consideration of germline genetic testing in multiple risk groups. Community urology practices can support guideline-aligned care by performing routine hereditary cancer risk assessment (HCRA), patient counseling and, when appropriate, genetic testing. This prospective registry will evaluate the feasibility and impact of implementing standard cancer family history review and guideline-aligned genetic testing for men diagnosed with PrCa in community urology practices nationwide.

03

Conditions studied

  • Prostate Cancer

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Keywords

  • Prostate Cancer Patients
  • myRisk genetic testing
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Prostate Cancer patients, at least 18 years or older, who meet NCCN guidelines and eligibility criteria, who have a scheduled set appointment at Community Urology practices.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18 Years of age or older at time of enrollment
  • Affected with Prostate Cancer (newly or previously diagnosed patients).
  • Presents for a medical care visit and meets eligibility criteria for hereditary cancer genetic testing, based on personal and family cancer history and NCCN Practice Guidelines in Oncology (Prostate Cancer)
  • Able to understand and agrees to participate in the registry.

Exclusion criteria

Exclusion Criteria:

  • Minors (younger than 18 years of age)
  • Have had previous genetic testing for Hereditary Breast and Ovarian Cancer or Lynch Syndrome, or have previously undergone hereditary multi-gene, pan-cancer, or panel testing.
  • Unable to provide routine clinical .
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
255 participants (actual)
Target follow-up
3 Years
Patient registry
Yes
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. To see how practical it would be to integrate a standard hereditary cancer risk assessment, patient counseling and genetic testing process into the community urology practice setting.

    To see how practical it would be to integrate a standard hereditary cancer risk assessment , patient counseling and genetic testing process into the community urology practice setting. Also to evaluate the impact of the integrated process on provider and patient satisfaction. This registry will gather information to evaluate the feasibility of HCRA and genetic testing process integration in the Urology community practice setting. Analysis of the registry will compare historical pre-process integration data with post-integration data from the same providers within participating community Urology practices.

    Time frame: 18 weeks per site

Secondary outcomes

  1. To see what the proportion of community urology patients with PrCa is who complete each component of the HCRA, patient counseling and genetic testing process.

    To see what the proportion of community urology patients with PrCa is who complete each component of the HCRA, patient counseling and genetic testing process. This registry will gather information to evaluate the feasibility of HCRA and genetic testing process integration in the Urology community practice setting. Analysis of the registry will compare historical pre-process integration data with post-integration data from the same providers within participating community Urology practices.

    Time frame: 18 weeks

07

Study locations

10 sites
  • Arkansas Urology
    Little Rock, Arkansas 72211, United States
  • Urology Associates of Central California
    Fresno, California 93720, United States
  • Urologic Specialists of Northwest Indiana
    Merrillville, Indiana 46410, United States
  • Comprehensive Urology
    Royal Oak, Michigan 48073, United States
  • Comprehensive Urology
    Waterford, Michigan 48328, United States
  • Associated Medical Professionals of New York
    Syracuse, New York 13210, United States
  • Associated Urologists of North Carolina
    Raleigh, North Carolina 27612, United States
  • Oregon Urology Institute
    Springfield, Oregon 97477, United States
  • MidLantic Urology
    Bala-Cynwyd, Pennsylvania 19004, United States
  • Carolina Urologic Research Center
    Myrtle Beach, South Carolina 29572, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2019 to primary completion in Oct 2020, 19 months.

Of 109 industry-sponsored observational studies under Prostatic Neoplasms, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 65. This study's 19 months is below that.

Counting every sponsor, half of 649 studies reached it within 60 months; a quarter within 29 and three quarters within 141.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 26, 2019
First posted
Jul 10, 2019
StartActual
Mar 6, 2019
Primary completionActual
Oct 21, 2020
CompletionActual
Oct 30, 2020
Last update
Nov 5, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04015102
Lead sponsor
Myriad Genetic Laboratories, Inc.
Collaborators
Carolina Urologic Research Center
Responsible party
Sponsor
First posted
Jul 10, 2019
Start date
Mar 6, 2019
Primary completion
Oct 21, 2020
Completion
Oct 30, 2020
Last update
Nov 5, 2020

Study contacts

Neal Shore, MD
principal investigator · Carolina Urologic Research Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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