PROMISE Registry: A Prostate Cancer Registry of Outcomes and Germline Mutations for Improved Survival and Treatment Effectiveness
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Biopsies
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
The PROMISE Registry studies how inherited gene changes linked to cancer affect prostate cancer outcomes and treatment results. It is for people in the United States with prostate cancer at any stage, including survivors. Participants give a saliva sample for gene testing, and those with certain gene changes are followed for at least 15 years.
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
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have prostate cancer at any stage, or be a prostate cancer survivor.
- Have the cancer confirmed by a tissue sample, a PSA blood test above the study’s cutoff, or clear signs of cancer on imaging scans.
- Live in the United States, including Puerto Rico, Guam, American Samoa, the U.S. Virgin Islands, or the Northern Mariana Islands.
Who can't join
- Cannot or do not want to provide all the information needed to check if you qualify.
- Do not meet all the requirements to join.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (3)
MD
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center · Baltimore, MD 21231Channing Paller, MD · Study contactChanning Paller, MD · Principal investigatorMore trials in Baltimore
NY
- Memorial Sloan Kettering Cancer Center · New York, NY 10065More trials in New York
WA
- University of Washington Medical Center · Seattle, WA 98195Heather Cheng, MD · Study contactHeather Cheng, MD · Principal investigatorMore trials in Seattle