Metastatic Prostate CancerNCT06009549
A Journey Into Participation Patterns Among Metastatic Prostate Cancer Patients
An observational study of Metastatic Prostate Cancer, run by Power Life Sciences Inc. at 1 site in United States.
Trial summary
Taking part in clinical trials usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Prostate Cancer
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2024to Sep 2026
- 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: Patients with metastatic prostate cancer who are actively considering enrolling in a clinical study, but have not yet completed enrollment and randomization.
Who may be able to join
- Patient is at least 18 years of age
- Diagnosis of metastatic prostate cancer
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Enrolled in another research study
- Patients with psychiatric illness/social situations that would limit compliance with study requirements
- Inability to provide written informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Power Life Sciences
San Francisco, California, 94107
Michael B Gill, 415-900-4227, https://www.withpower.com/contact-us@withpower.com
About this study
Official title: Engagement Trends in Clinical Trials for Metastatic Prostate Cancer - A Journey Into Participation Patterns Among Individuals Affected by the Condition
Taking part in clinical trials usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups.
This research will admit a wide range of data on the clinical study experience of metastatic prostate cancer patients to determine which factors prevail in limiting a patient's ability to join or finish a trial.
It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future patients with metastatic prostate cancer.
- Conditions
- Metastatic Prostate Cancer
- Keywords
- metastatic prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who decide to participate in a metastatic prostate cancer clinical research
Measured: 3 months
Rate of patients who remain in metastatic prostate cancer clinical research to trial completion
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study startSep 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Metastatic Prostate CancerStudies of the same condition, open and under way.
- More trials run by Power Life Sciences Inc.The 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Power Life Sciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael B Gill, Study director, Power Life Sciences Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06009549
- Sponsor's protocol ID
- 88079658
- Status last verified
- Aug 2023
- First submitted
- 18 Aug 2023
- Last updated
- 24 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pouliot F, Beauregard JM, Saad F, Trudel D, Richard PO, Turcotte E, Rousseau E, Probst S, Kassouf W, Anidjar M, Camirand Lemyre F, Bouvet GF, Neveu B, Tetu A, Guerin B. The Triple-Tracer strategy against Metastatic PrOstate cancer (3TMPO) study protocol. BJU Int. 2022 Sep;130(3):314-322. doi: 10.1111/bju.15621. Epub 2021 Nov 11.
PubMed 34674367Vlaming M, Bleiker EMA, van Oort IM, Kiemeney LALM, Ausems MGEM. Mainstream germline genetic testing in men with metastatic prostate cancer: design and protocol for a multicenter observational study. BMC Cancer. 2022 Dec 30;22(1):1365. doi: 10.1186/s12885-022-10429-2.
PubMed 36581909Presti J Jr, Alexeeff S, Horton B, Prausnitz S, Avins AL. Changes in Prostate Cancer Presentation Following the 2012 USPSTF Screening Statement: Observational Study in a Multispecialty Group Practice. J Gen Intern Med. 2020 May;35(5):1368-1374. doi: 10.1007/s11606-019-05561-y. Epub 2019 Dec 9.
PubMed 31820217
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engagement Trends in Clinical Trials for Metastatic Prostate Cancer - A Journey Into Participation Patterns Among Individuals Affected by the Condition
- ClinicalTrials.gov ID
- NCT06009549
- Acronym / sponsor ID
- 88079658
- Conditions
- Metastatic Prostate Cancer
- Keywords
- metastatic prostate cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Power Life Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 24 Aug 2023 (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.
Taking part in clinical trials usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups.
This research will admit a wide range of data on the clinical study experience of metastatic prostate cancer patients to determine which factors prevail in limiting a patient's ability to join or finish a trial.
It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future patients with metastatic prostate cancer.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic prostate cancer who are actively considering enrolling in a clinical study, but have not yet completed enrollment and randomization.
Key inclusion criteria (3 listed)
- Patient is at least 18 years of age
- Diagnosis of metastatic prostate cancer
- Ability to understand and the willingness to sign a written informed consent document
Key exclusion criteria (3 listed)
- Enrolled in another research study
- Patients with psychiatric illness/social situations that would limit compliance with study requirements
- Inability to provide written 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
Number of patients who decide to participate in a metastatic prostate cancer clinical research
Time frame: 3 months
Rate of patients who remain in metastatic prostate cancer clinical research to trial completion
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Background: PubMed 34674367Pouliot F, Beauregard JM, Saad F, Trudel D, Richard PO, Turcotte E, Rousseau E, Probst S, Kassouf W, Anidjar M, Camirand Lemyre F, Bouvet GF, Neveu B, Tetu A, Guerin B. The Triple-Tracer strategy against Metastatic PrOstate cancer (3TMPO) study protocol. BJU Int. 2022 Sep;130(3):314-322. doi: 10.1111/bju.15621. Epub 2021 Nov 11.
- Background: PubMed 36581909Vlaming M, Bleiker EMA, van Oort IM, Kiemeney LALM, Ausems MGEM. Mainstream germline genetic testing in men with metastatic prostate cancer: design and protocol for a multicenter observational study. BMC Cancer. 2022 Dec 30;22(1):1365. doi: 10.1186/s12885-022-10429-2.
- Background: PubMed 31820217Presti J Jr, Alexeeff S, Horton B, Prausnitz S, Avins AL. Changes in Prostate Cancer Presentation Following the 2012 USPSTF Screening Statement: Observational Study in a Multispecialty Group Practice. J Gen Intern Med. 2020 May;35(5):1368-1374. doi: 10.1007/s11606-019-05561-y. Epub 2019 Dec 9.
- Individual participant dataSharing planned: Undecided
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RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
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RecruitingObservational study
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Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
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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.
Michael B Gill study director
Power Life Sciences Inc.
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 Metastatic Prostate Cancer, run by Power Life Sciences Inc. 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 24 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael B Gill (4159004227, bask@withpower.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who decide to participate in a metastatic prostate cancer clinical research (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06009549, which also lists 3 linked publications.
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 24 Aug 2023.