Prostate CancerNCT02154672
Prostate Cancer Screening in Men With Germline BRCA2 Mutations
An observational study of Prostate Cancer, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to determine the incidence of prostate cancer in men with the BRCa2 gene mutation as an independent indicator for prostate cancer screening. Read more about this study
- Who is it for?
- Ages 30 to 90 years, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to 1 Nov 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Study participants will be identified because of their BRCA2 mutation that places them at increased risk for developing prostate cancer. Because this is a pre-selected high-risk population, and our goal is to establish the incidence of cancer and association of risk factors with developing disease, all men ≥30 years of age, able to give informed consent, and with at least a 5-10 year life expectancy will have PSA testing, prostate examination, Pelvic MRI, and Artemis fusion prostate biopsy. Men identified to have prostate cancer will be treated according to current standards of care. Treatment for prostate cancer at the Yale Cancer Center is largely based on clinical risk; options include, but are not limited to, active surveillance for appropriate men with low risk disease, treatment with curative intent for men with localized intermediate and high risk prostate cancer, and systemic therapy for men with metastatic disease.
Who may be able to join
- All men ≥30 years of age with at least a ten-year life expectancy
- A known BRCA2 mutation
- Ability to have an MRI
- Able to give informed consent will be approached to participate in the study
Who cannot join
- If a man has received or is currently receiving treatment for prostate cancer
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the incidence of prostate cancer in men with the BRCa2 gene mutation as an independent indicator for prostate cancer screening.
Read the detailed description
This is a cohort screening study to prospectively identify the incidence of prostate cancer in a population of BRCA2 carriers. All men identified to have a BRCA2 mutation as part of the Yale Cancer Genetic Counseling Program will be approached and offered participation in the study via our program newsletter, BRCA listserv, Facebook page and a targeted mailing.
Standard of care screening at the Yale Cancer Center for men with a normal prostate cancer risk consists of a PSA test and prostate physical examination beginning at age 50 years and if either is abnormal an MRI of the prostate followed by Fusion-targeted biopsy of the prostate is performed.
- Conditions
- Prostate Cancer
- 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 |
|---|---|---|
| BRCA2 Carriers | All men identified to have a BRCA2 mutation as part of the Yale Cancer Genetic Counseling Program will be approached and offered participation in the study via our program newsletter, BRCA listserv, Facebook page and a targeted mailing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Prostate Cancer Patients With BRCA2 Mutation Carriers
number of patients with a BRCA2 mutation who are diagnosed with prostate cancer
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startMay 2014
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Preston Sprenkle, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02154672
- Sponsor's protocol ID
- 1402013376
- Status last verified
- Jan 2021
- First submitted
- 30 May 2014
- Last updated
- 9 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Cancer Screening in Men With Germline BRCA2 Mutations
- ClinicalTrials.gov ID
- NCT02154672
- Acronym / sponsor ID
- 1402013376
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 3 Jun 2014 (estimated)
- Results
- Posted 9 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the incidence of prostate cancer in men with the BRCa2 gene mutation as an independent indicator for prostate cancer screening.
Detailed description
This is a cohort screening study to prospectively identify the incidence of prostate cancer in a population of BRCA2 carriers. All men identified to have a BRCA2 mutation as part of the Yale Cancer Genetic Counseling Program will be approached and offered participation in the study via our program newsletter, BRCA listserv, Facebook page and a targeted mailing.
Standard of care screening at the Yale Cancer Center for men with a normal prostate cancer risk consists of a PSA test and prostate physical examination beginning at age 50 years and if either is abnormal an MRI of the prostate followed by Fusion-targeted biopsy of the prostate is performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BRCA2 Carriers | – | –All men identified to have a BRCA2 mutation as part of the Yale Cancer Genetic Counseling Program will be approached and offered participation in the study via our program newsletter, BRCA listserv, Facebook page and a targeted mailing |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be identified because of their BRCA2 mutation that places them at increased risk for developing prostate cancer. Because this is a pre-selected high-risk population, and our goal is to establish the incidence of cancer and association of risk factors with developing disease, all men ≥30 years of age, able to give informed consent, and with at least a 5-10 year life expectancy will have PSA testing, prostate examination, Pelvic MRI, and Artemis fusion prostate biopsy. Men identified to have prostate cancer will be treated according to current standards of care. Treatment for prostate cancer at the Yale Cancer Center is largely based on clinical risk; options include, but are not limited to, active surveillance for appropriate men with low risk disease, treatment with curative intent for men with localized intermediate and high risk prostate cancer, and systemic therapy for men with metastatic disease.
Key inclusion criteria (4 listed)
- All men ≥30 years of age with at least a ten-year life expectancy
- A known BRCA2 mutation
- Ability to have an MRI
- Able to give informed consent will be approached to participate in the study
Key exclusion criteria (1 listed)
- If a man has received or is currently receiving treatment for prostate cancer
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
Number of Prostate Cancer Patients With BRCA2 Mutation Carriers
Time frame: Up to 3 years
number of patients with a BRCA2 mutation who are diagnosed with prostate cancer
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Preston Sprenkle, MD principal investigator
Yale University
1 site 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 Yale University at 1 site 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 4 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 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 9 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Prostate Cancer Patients With BRCA2 Mutation Carriers (time frame: Up to 3 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 9 Feb 2021.