Prostate CancerNCT03807492
Evaluation and Management for Prostate Oncology, Wellness, and Risk (EMPOWeR)
An observational study of Prostate Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
Trial summary
The EMPOWeR study is proposed as a cohort study with longitudinal follow-up to determine rates of genetic mutations among men with or at-risk for prostate cancer to address the various facets of genetic education and counseling for optimized genetic assessment and wellness of men. 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
- 241 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2019to 7 Feb 2024
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Any male >18 years with prostate cancer is eligible. Furthermore, unaffected men at higher risk for prostate cancer (family history of prostate cancer or African American males) are also eligible for the study. Men will be approached by their providers or study staff during their clinical appointments for participation. Emails or mailings may also be sent to introduce the study to patients and to contact us for participation. Men who previously participated in the Genetic Evaluation of Men (GEM) study (IRB#14S.546) will be offered participation in EMPOWeR.
Who may be able to join
- Men with a personal history of prostate cancer
- Unaffected males who are at higher risk for prostate cancer (family history of prostate cancer or African American males)
- Men who previously tested positive for a mutation may be eligible for Specific Aims 2-7
- Men with a known familial mutation
- Men who previously participated in the Genetic Evaluation of Men (GEM) study (IRB#14S.546) will be offered participation in EMPOWeR -
Who cannot join
- Age < 18 years
- Mental or cognitive impairment that interferes with ability to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
The EMPOWeR study is proposed as a cohort study with longitudinal follow-up to determine rates of genetic mutations among men with or at-risk for prostate cancer to address the various facets of genetic education and counseling for optimized genetic assessment and wellness of men. The results will inform practice guidelines and future studies for maximal impact of genetic evaluation of men for inherited prostate cancer.
- 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 |
|---|---|---|
| EMPOWeR Study | This is a cohort study, with initial patient assessments and longitudinal follow-up. Participation of subjects will be indefinite, which will be discussed in the informed consent. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perform genetic testing for men with or at-risk for prostate cancer to determine association of mutations to patient characteristics.
Participants will undergo gene panel testing through a saliva or blood sample. A genetic test summary will be generated to give to participants at disclosure of results. Participants will receive genetic test results in person, by phone or via telehealth. Fisher's exact test will be used to determine association of mutations and variants to patient characteristics.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start16 Jan 2019
- Primary completion1 Jun 2022
- Study completion7 Feb 2024
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
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03807492
- Sponsor's protocol ID
- 18D.644
- Other IDs
- JT 13180
- Status last verified
- May 2025
- First submitted
- 21 Dec 2018
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Management for Prostate Oncology, Wellness, and Risk (EMPOWeR)
- ClinicalTrials.gov ID
- NCT03807492
- Acronym / sponsor ID
- 18D.644
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 16 Jan 2019 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 7 Feb 2024 (actual)
- First posted
- 17 Jan 2019 (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.
The EMPOWeR study is proposed as a cohort study with longitudinal follow-up to determine rates of genetic mutations among men with or at-risk for prostate cancer to address the various facets of genetic education and counseling for optimized genetic assessment and wellness of men. The results will inform practice guidelines and future studies for maximal impact of genetic evaluation of men for inherited prostate cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EMPOWeR Study | – | –This is a cohort study, with initial patient assessments and longitudinal follow-up. Participation of subjects will be indefinite, which will be discussed in the informed consent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any male >18 years with prostate cancer is eligible. Furthermore, unaffected men at higher risk for prostate cancer (family history of prostate cancer or African American males) are also eligible for the study. Men will be approached by their providers or study staff during their clinical appointments for participation. Emails or mailings may also be sent to introduce the study to patients and to contact us for participation. Men who previously participated in the Genetic Evaluation of Men (GEM) study (IRB#14S.546) will be offered participation in EMPOWeR.
Key inclusion criteria (5 listed)
- Men with a personal history of prostate cancer
- Unaffected males who are at higher risk for prostate cancer (family history of prostate cancer or African American males)
- Men who previously tested positive for a mutation may be eligible for Specific Aims 2-7
- Men with a known familial mutation
- Men who previously participated in the Genetic Evaluation of Men (GEM) study (IRB#14S.546) will be offered participation in EMPOWeR -
Key exclusion criteria (2 listed)
- Age < 18 years
- 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.
Primary outcome
Perform genetic testing for men with or at-risk for prostate cancer to determine association of mutations to patient characteristics.
Time frame: 6 months
Participants will undergo gene panel testing through a saliva or blood sample. A genetic test summary will be generated to give to participants at disclosure of results. Participants will receive genetic test results in person, by phone or via telehealth. Fisher's exact test will be used to determine association of mutations and variants to patient characteristics.
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 15 May 2025.
- Thomas Jefferson University HospitalLink provided by the sponsor.
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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.
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 Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson 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 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: finished, as of the sponsor's last update on 15 May 2025. 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?
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?
Perform genetic testing for men with or at-risk for prostate cancer to determine association of mutations to patient characteristics. (time frame: 6 months). 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 May 2025.