Recruiting

Prostate Cancer

Sponsor:

Prostate Cancer Clinical Trials Consortium

Code:

NCT04995198

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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

Conditions

Prostate Cancer

Study ID

NCT04995198

Start date

May 3, 2021

Status verified date

Sep, 2026

Completion date

Dec 31, 2037

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Participants with at least one germline pathogenic/likely pathogenic variant

Participants with at least one variant of uncertain significance

Primary outcome measure

  • Frequency of at least one germline pathogenic or likely pathogenic variant [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Jacob Vinson

646-449-3363pcctcpromise@mskcc.org

Locations

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Recruiting

Baltimore, Maryland, United States, 21231

Principal Investigator:

Channing Paller, MD

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

University of Washington Medical Center

Recruiting

Seattle, Washington, United States, 98195

Principal Investigator:

Heather Cheng, MD

More Information

Sponsor

Prostate Cancer Clinical Trials Consortium

Last update posted

Sep 15, 2026

Last verified

Sep, 2026

Keywords

  • Prostate Cancer
  • Genetics
  • Registry
  • Germline Mutation
  • Genetic Testing
  • Germline Testing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by Prostate Cancer Clinical Trials Consortium on 2026-09-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.