Prostate CancerNCT05447637
PROCLAIM: Germline Genetic Testing for Prostate Cancer Patients
An observational study of Prostate Cancer, run by Invitae Corporation at 19 sites in United States.
Trial summary
This registry is for men who have prostate cancer and have had multigene panel hereditary testing. The registry will gather data on genetic testing results and how that information may change physician treatment or follow up recommendations. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Invitae multi-cancer gene panel
- How many people
- 1,000 participants
- Where
- 19 sitesUnited States
- Study dates
- 1 Nov 2019to 31 May 2022
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men who have a diagnosis of prostate cancer who have not previously undergone testing for multi-gene hereditary cancer risk.
Who may be able to join
- Men ages 18-90 who have been prescribed genetic testing as part of their clinical care
- Have prostate cancer at any stage, either actively under treatment or being followed who either: 1. meet NCCN criteria for testing or 2. do not meet NCCN criteria for testing
- Patients who are naive to clinical genetic testing for BRCA1/BRCA2 (single gene panel testing)
Who cannot join
- Mental or cognitive impairment that interferes with ability to provide informed consent
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Urology Partners
Arlington, Texas, 76017
Urology Austin
Austin, Texas, 78759
MidLantic Urology
Bala-Cynwyd, Pennsylvania, 19004
Associated Urological Specialists
Chicago Ridge, Illinois, 60415
North Georgia Urology
Dalton, Georgia, 30720
University Urology Associates of New Jersey
Hamilton, New Jersey, 08690
Urosurgery Houston
Houston, Texas, 77002
Colorado Urology
Lakewood, Colorado, 80228
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Urology Associates, P.C.
Nashville, Tennessee, 37211
Perlmutter Cancer Center, NYU Langone Health, New York
New York, New York, 10016
Genesis Healthcare Partners
San Diego, California, 92123
Invitae
San Francisco, California, 94103
Department of Bioengineering and Therapeutic Sciences, University of California San Francisco
San Francisco, California, 94158
Volunteer Faculty, University of California San Francisco
San Francisco, California, 94158
Advanced Urology Institute
St. Petersburg, Florida, 33710
Associated Medical Professionals
Syracuse, New York, 13210
Florida Urology Partners
Tampa, Florida, 33606
TGH Cancer Institute
Tampa, Florida, 33606
About this study
Official title: A Multi-center Prospective Observational Study of Community Urology Practices Applying Germline Genetic Testing for Prostate Cancer Patients (PROCLAIM)
This registry is for men who have prostate cancer and have had multigene panel hereditary testing. The registry will gather data on genetic testing results and how that information may change physician treatment or follow up recommendations. It will also gather data on the patient's experience with genetic testing, through a post-test survey to be completed 60-90days after results have been received and discussed with their provider.
Read the detailed description
This registry will enroll men with prostate cancer who have done multi-gene testing for their cancer. Patients will be enrolled into two cohorts, one for individuals who meet current NCCN testing guidelines, and one for individuals who do not meet current NCCN guidelines.
The main goal of this Registry is to assess whether nationally developed guidelines used to select patients for hereditary testing are adequate to identify all patients with prostate cancer who may benefit from testing. Patients will completed a post-test survey regarding their testing experience and clinicians will be asked to provide additional medical records review information via the Clinician Report Form.
- Conditions
- Prostate Cancer
- Being tested
- Invitae multi-cancer gene panel
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invitae multi-cancer gene panelDiagnostic test
Invitae's multi-cancer panel tests for 84 genes associated with hereditary cancer risk.
| Study group | Role | What they receive |
|---|---|---|
| Individuals who meet NCCN Testing Criteria | Not described Receives: Diagnostic Test: Invitae multi-cancer gene panel | |
| Individuals who do not meet NCCN Testing Criteria | Not described Receives: Diagnostic Test: Invitae multi-cancer gene panel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield of pathogenic and likely pathogenic genes in the patient population
Identify the diagnostic yield of pathogenic/likely pathogenic variants in known cancer syndrome genes in patients with prostate cancer, using the Invitae 84 gene multi-cancer panel. These rates will be compared between the two cohorts.
Measured: to be assessed at baseline only
Secondary outcomes (2)
Evaluate the sensitivity of current NCCN criteria for germline genetic testing for identifying prostate cancer patients that have pathogenic/likely pathogenic variants
Compare rates of pathogenic / likely pathogenic variants found in both cohorts after testing using the Invitae 84 gene multi cancer panel.
Measured: at baseline only
Evaluate the impact of genetic test results on clinical management decisions
Post-Test surveys for patients and the clinician report form will assess whether changes to clinical management were made as a result of the test results.
Measured: 60-90 days post test results received.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start1 Nov 2019
- Primary completion1 Jul 2021
- Study completion31 May 2022
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
- 1,000 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Invitae Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05447637
- Sponsor's protocol ID
- INVPC-1000
- Status last verified
- Jul 2022
- First submitted
- 1 Jul 2022
- Last updated
- 7 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD at this time.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Prospective Observational Study of Community Urology Practices Applying Germline Genetic Testing for Prostate Cancer Patients (PROCLAIM)
- ClinicalTrials.gov ID
- NCT05447637
- Acronym / sponsor ID
- INVPC-1000
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Invitae CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 7 Jul 2022 (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.
This registry is for men who have prostate cancer and have had multigene panel hereditary testing. The registry will gather data on genetic testing results and how that information may change physician treatment or follow up recommendations. It will also gather data on the patient's experience with genetic testing, through a post-test survey to be completed 60-90days after results have been received and discussed with their provider.
Detailed description
This registry will enroll men with prostate cancer who have done multi-gene testing for their cancer. Patients will be enrolled into two cohorts, one for individuals who meet current NCCN testing guidelines, and one for individuals who do not meet current NCCN guidelines.
The main goal of this Registry is to assess whether nationally developed guidelines used to select patients for hereditary testing are adequate to identify all patients with prostate cancer who may benefit from testing. Patients will completed a post-test survey regarding their testing experience and clinicians will be asked to provide additional medical records review information via the Clinician Report Form.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals who meet NCCN Testing Criteria | – | Diagnostic Test: Invitae multi-cancer gene panel |
| Individuals who do not meet NCCN Testing Criteria | – | Diagnostic Test: Invitae multi-cancer gene panel |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men who have a diagnosis of prostate cancer who have not previously undergone testing for multi-gene hereditary cancer risk.
Key inclusion criteria (3 listed)
- Men ages 18-90 who have been prescribed genetic testing as part of their clinical care
- Have prostate cancer at any stage, either actively under treatment or being followed who either: 1. meet NCCN criteria for testing or 2. do not meet NCCN criteria for testing
- Patients who are naive to clinical genetic testing for BRCA1/BRCA2 (single gene panel testing)
Key exclusion criteria (1 listed)
- Mental or cognitive impairment that interferes with ability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Invitae multi-cancer gene panelInvitae's multi-cancer panel tests for 84 genes associated with hereditary cancer risk. | Diagnostic test | Individuals who do not meet NCCN Testing Criteria, Individuals who meet NCCN Testing Criteria |
Primary outcome
Diagnostic yield of pathogenic and likely pathogenic genes in the patient population
Time frame: to be assessed at baseline only
Identify the diagnostic yield of pathogenic/likely pathogenic variants in known cancer syndrome genes in patients with prostate cancer, using the Invitae 84 gene multi-cancer panel. These rates will be compared between the two cohorts.
2 secondary outcomes
Evaluate the sensitivity of current NCCN criteria for germline genetic testing for identifying prostate cancer patients that have pathogenic/likely pathogenic variants
Time frame: at baseline only
Evaluate the impact of genetic test results on clinical management decisions
Time frame: 60-90 days post test results received.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
- Individual participant dataSharing planned: No. No plan to share IPD at this time.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
19 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 Invitae Corporation at 19 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 7 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic yield of pathogenic and likely pathogenic genes in the patient population (time frame: to be assessed at baseline only). 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 7 Jul 2022.