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NCT Number: NCT04995198

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

PROMISE aims to create a comprehensive nationwide registry of prostate cancer patients with germline pathogenic variants by prospectively screening approximately 5,000 subjects with a confirmed prostate cancer diagnosis, either through tissue biopsy, PSA greater than 100 ng/dL and/or radiographic evidence of disease and receiving systemic therapy for prostate cancer. Patients at all stages of disease will be welcome to participate in the PROMISE Registry.

Participants will be recruited & screened over a five-year period. Study participants will be asked to provide a saliva sample to be tested for germline cancer risk variants through Color Health. If the results identify a pathogenic or likely pathogenic variant, an appointment with a genetic counselor from Color Health will be scheduled to discuss the results.

Participants will complete a baseline demographic survey that includes self-reported health history, family history of cancer and standardized patient reported outcome (PRO) measures.

PROMISE Registry staff will request medical records from the participant's cancer care provider(s) for the purpose of obtaining clinical data.

Participants will receive bi-annual newsletters offering information on new developments in treatment and research opportunities, including clinical trials, associated with genetic variants.

Eligible participants (those with target germline mutations) will be followed every 6 months to obtain updated health records data and patient-reported outcomes data. Participants will be followed for a minimum of 15 years.

The PROMISE registry will help identify prostate cancer patients with pathogenic variants to learn more about how these variants affect patient outcomes. Ultimately, we hope to help patients learn more about their disease and the treatments that they may derive the most benefit from, including the germline genetic biomarker-based clinical trials they may be eligible for.

For more information, visit the study website at: prostatecancerpromise.org

Recruiting

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • Unable or unwilling to provide all of the necessary information for eligibility
  • Incomplete inclusion criteria

Treatment and study plan

Primary outcomes

  1. Frequency of at least one germline pathogenic or likely pathogenic variant

    Time frame: 5 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.

Secondary outcomes

  1. Frequency of pathogenic or likely pathogenic germline variants of interest

    Time frame: 5 years

    Frequency of pathogenic or likely pathogenic germline variants of interest in subjects with prostate cancer. We will estimate the frequency of having each of the germline pathogenic or likely pathogenic variant in the cancer risk genes based on the number of subjects screened in each subpopulation.

  2. Identify and recruit control group of patients with a variant of uncertain significance (VUS)

    Time frame: 5 years

    Identify and recruit a control group of patients with a VUS in their clinical or research results in the following genes: ATM, ATR, BARD1, BRCA1, BRCA2, FAM175A, GEN1, HOXB13, MRE11A, PALB2 and XRCC2.

  3. Association between disease characteristics and genetic variants

    Time frame: 15 years

    Collect data on disease characteristics and examine the association between disease characteristics and pathogenic and likely pathogenic germline variants and VUS of interest.

  4. Analysis of patient reported outcomes (PRO) measures

    Time frame: 15 years

    Collect PRO measures associated with genetic testing in subjects with prostate cancer using the validated EORTC QLQ-C30.

  5. Analysis of longitudinal outcome data

    Time frame: 15 years

    Collect longitudinal outcome data on subjects with pathogenic and likely pathogenic germline variants and VUS of interest, for specific treatments, treatment sequences or therapy combinations used for treating prostate cancer.

  6. Comparison of overall survival

    Time frame: 15 years

    Compare overall survival in subjects with pathogenic and likely pathogenic germline variants of interest and subjects with VUS.

Study contacts

Contact information is provided by the study sponsor or research team.

Jacob Vinson

CONTACT

[email protected]

646-449-3363

Sponsors and collaborators

Lead sponsor

Prostate Cancer Clinical Trials Consortium

Other

Collaborators

  • Advancing Cancer Treatment, Inc.
  • Fred Hutchinson Cancer Center
  • Memorial Sloan Kettering Cancer Center
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2036
First posted
Aug 6, 2021
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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