Prostate CancerNCT04995198
PROMISE Registry: A Prostate Cancer Registry of Outcomes and Germline Mutations for Improved Survival and Treatment Effectiveness
An observational study of Prostate Cancer, run by Prostate Cancer Clinical Trials Consortium at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 500 participants
- Where
- 3 sitesUnited States
- Study dates
- 3 May 2021to 31 Dec 2037
- How long will I take part?
- 15 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with prostate cancer (any stage of disease or survivorship). Individuals are eligible whether they have had prior germline genetic testing or not.
Who may be able to join
- 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)
Who cannot join
- Unable or unwilling to provide all of the necessary information for eligibility
- Incomplete inclusion criteria
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231
Channing Paller, MD
Channing Paller, MD
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
- Recruiting
University of Washington Medical Center
Seattle, Washington, 98195
Heather Cheng, MD
Heather Cheng, MD
About this study
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.
Read more
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
- Keywords
- Prostate Cancer, Genetics, Registry, Germline Mutation, Genetic Testing, Germline Testing
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants with at least one germline pathogenic/likely pathogenic variant | Not described | |
| Participants with at least one variant of uncertain significance | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of at least one germline pathogenic or likely pathogenic variant
Frequency of having at least one germline pathogenic or likely pathogenic variant in a cancer risk gene based on the number of subjects screened.
Measured: 5 years
Secondary outcomes (6)
Frequency of pathogenic or likely pathogenic germline variants of interest
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.
Measured: 5 years
Identify and recruit control group of patients with a variant of uncertain significance (VUS)
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.
Measured: 5 years
Association between disease characteristics and genetic variants
Collect data on disease characteristics and examine the association between disease characteristics and pathogenic and likely pathogenic germline variants and VUS of interest.
Measured: 15 years
Analysis of patient reported outcomes (PRO) measures
Collect PRO measures associated with genetic testing in subjects with prostate cancer using the validated EORTC QLQ-C30.
Measured: 15 years
Analysis of longitudinal outcome data
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.
Measured: 15 years
Comparison of overall survival
Compare overall survival in subjects with pathogenic and likely pathogenic germline variants of interest and subjects with VUS.
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start3 May 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 15 Years
Sponsor and investigators
- Lead sponsor
- Prostate Cancer Clinical Trials Consortium
- Sponsor type
- University, hospital or other
- Collaborators
- Memorial Sloan Kettering Cancer Center, Fred Hutchinson Cancer Center, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Advancing Cancer Treatment, Inc.
- Responsible party
- Sponsor
- Investigators
- Heather Cheng, MD, PhD, Principal investigator, Fred Hutchinson Cancer CenterChanning Paller, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04995198
- Sponsor's protocol ID
- c19-235
- Status last verified
- Sep 2026
- First submitted
- 29 Jul 2021
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROMISE Registry: A Prostate Cancer Registry of Outcomes and Germline Mutations for Improved Survival and Treatment Effectiveness
- ClinicalTrials.gov ID
- NCT04995198
- Acronym / sponsor ID
- c19-235
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Genetics, Registry, Germline Mutation, Genetic Testing, Germline Testing
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Prostate Cancer Clinical Trials ConsortiumUniversity, hospital or other
- Collaborators
- Memorial Sloan Kettering Cancer Center, Fred Hutchinson Cancer Center, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Advancing Cancer Treatment, Inc.
- Study start
- 3 May 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2037 (estimated)
- First posted
- 6 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with at least one germline pathogenic/likely pathogenic variant | – | – |
| Participants with at least one variant of uncertain significance | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with prostate cancer (any stage of disease or survivorship). Individuals are eligible whether they have had prior germline genetic testing or not.
Key inclusion criteria (5 listed)
- Have prostate cancer (any stage of disease or survivorship) diagnosed or documented through one of the following:
- Live in the United States (including Puerto Rico, Guam, American Samoa, US Virgin Islands, Northern Mariana Islands)
Key exclusion criteria (2 listed)
- Unable or unwilling to provide all of the necessary information for eligibility
- Incomplete inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
Frequency of pathogenic or likely pathogenic germline variants of interest
Time frame: 5 years
Identify and recruit control group of patients with a variant of uncertain significance (VUS)
Time frame: 5 years
Association between disease characteristics and genetic variants
Time frame: 15 years
Analysis of patient reported outcomes (PRO) measures
Time frame: 15 years
Analysis of longitudinal outcome data
Time frame: 15 years
Comparison of overall survival
Time frame: 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- PROMISE Study SiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Heather Cheng, MD, PhD principal investigator
Fred Hutchinson Cancer Center
Channing Paller, MD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Prostate Cancer Clinical Trials Consortium at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacob Vinson (646-449-3363, pcctcpromise@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of at least one germline pathogenic or likely pathogenic variant (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.