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PROMISE Registry for Prostate Cancer Outcomes and Germline Mutations

The PROMISE Registry is an observational study for men with prostate cancer in the United States. This registry aims to understand the connection between prostate cancer and inherited genetic changes (germline pathogenic variants). You can join if you have prostate cancer, regardless of its stage, confirmed by a tissue biopsy, a high PSA level (a blood test marker for prostate health), or clear imaging results. The study will look at how often these genetic changes are found in participants over five years. The goal is to gather information that could lead to better treatments and improved survival for prostate cancer patients.

Study design
This is an observational study aiming to enroll about 500 men with prostate cancer. It is not testing a new treatment but rather collecting information.
What's involved
You would provide a saliva sample to be tested for inherited cancer risk genes. You will be recruited and screened over a five-year period.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, the frequency of germline variants, will be measured at 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04995198

PROMISE Registry: A Prostate Cancer Registry of Outcomes and Germline Mutations for Improved Survival and Treatment Effectiveness

Recruiting
Not specifiedAges 18+Observational
Prostate Cancer Clinical Trials Consortium
~500 participants
Updated 2024-08-07 on ClinicalTrials.gov

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Frequency of at least one germline pathogenic or likely pathogenic variant
Measured over 5 years

Conditions

Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

3 sites across 3 states
Maryland1
New York1
Washington1

Study leadership

  • Heather Cheng, MD, PhD · PRINCIPAL_INVESTIGATOR · Fred Hutchinson Cancer Center
  • Channing Paller, MD · PRINCIPAL_INVESTIGATOR · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Who to contact

Jacob Vinson
[email protected]
646-449-3363
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Have prostate cancer (any stage of disease or survivorship) diagnosed or documented through one of the following:
tissue biopsy, and/or
PSA greater than 100 ng/dL (1ng/ml), and/or
clear radiographic evidence of disease
Live in the United States (including Puerto Rico, Guam, American Samoa, US Virgin Islands, Northern Mariana Islands)

Exclusion

Unable or unwilling to provide all of the necessary information for eligibility

What this trial measures

  • Frequency of at least one germline pathogenic or likely pathogenic variant5 years

    Frequency of having at least one germline pathogenic or likely pathogenic variant in a cancer risk gene based on the number of subjects screened.