Prostate CancerNCT05411354
Analyzing Clinical Trial Experiences of Prostate Cancer Patients
An observational study of Prostate Cancer, run by Power Life Sciences Inc. at 1 site in United States.
Trial summary
Participation in clinical trials usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the participation or 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
- Prostate Cancer
- How many people
- 400 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: Prostate Cancer patients who are actively considering enrolling in an interventional clinical trial to treat their Prostate Cancer, but have yet to complete randomization and enrollment.
Who may be able to join
- Patient has been diagnosed with Prostate Cancer as identified by imaging
- Patient has self-identified as planning to enroll in an interventional clinical trial for Prostate Cancer
- Patient is at least 18 years of age
Who cannot join
- Patient does not understand, sign, and return consent form
- Inability to perform regular electronic reporting
- Patient has a ECOG score of 4
Trial locations and contacts
1 site in 1 country.
United States1 site
Power Life Sciences
San Francisco, California, 94107
About this study
Official title: Analyzing Clinical Trial Experiences of Prostate Cancer Patients To Determine How Trial Attributes Affect Completion Rates For Specific Demographic Groups
Participation in clinical trials usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the participation or completion of these specific demographic groups.
This study will admit a wide range of data on the clinical trial experience of 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 shed insights for the sake of future Prostate Cancer patients.
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Prostate, Prostate Clinical Trials
- Medical subject headings
- Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients who decide to enroll in a Prostate Cancer Clinical Trial
Measured: 3 months
Number of patients who remain in Prostate Cancer clinical trial until completion of clinical trial
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 posted9 Jun 2022
- 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 (2)Papers the sponsor has linked to this study.
- Other trials for 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
- 400 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 Science Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05411354
- Sponsor's protocol ID
- 585375c1448bfa3494298bdd794080
- Status last verified
- Dec 2023
- First submitted
- 5 Jun 2022
- Last updated
- 2 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
McKay RR, Gold T, Zarif JC, Chowdhury-Paulino IM, Friedant A, Gerke T, Grant M, Hawthorne K, Heath E, Huang FW, Jackson MD, Mahal B, Ogbeide O, Paich K, Ragin C, Rencsok EM, Simmons S, Yates C, Vinson J, Kantoff PW, George DJ, Mucci LA. Tackling Diversity in Prostate Cancer Clinical Trials: A Report From the Diversity Working Group of the IRONMAN Registry. JCO Glob Oncol. 2021 Apr;7:495-505. doi: 10.1200/GO.20.00571.
PubMed 33835826Rencsok EM, Bazzi LA, McKay RR, Huang FW, Friedant A, Vinson J, Peisch S, Zarif JC, Simmons S, Hawthorne K, Villanti P, Kantoff PW, Heath E, George DJ, Mucci LA. Diversity of Enrollment in Prostate Cancer Clinical Trials: Current Status and Future Directions. Cancer Epidemiol Biomarkers Prev. 2020 Jul;29(7):1374-1380. doi: 10.1158/1055-9965.EPI-19-1616. Epub 2020 Jun 5.
PubMed 32503813
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analyzing Clinical Trial Experiences of Prostate Cancer Patients To Determine How Trial Attributes Affect Completion Rates For Specific Demographic Groups
- ClinicalTrials.gov ID
- NCT05411354
- Acronym / sponsor ID
- 585375c1448bfa3494298bdd794080
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Prostate, Prostate Clinical Trials
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 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
- 9 Jun 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.
Participation in clinical trials usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the participation or completion of these specific demographic groups.
This study will admit a wide range of data on the clinical trial experience of 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 shed insights for the sake of future Prostate Cancer patients.
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
- Prostate Cancer patients who are actively considering enrolling in an interventional clinical trial to treat their Prostate Cancer, but have yet to complete randomization and enrollment.
Key inclusion criteria (3 listed)
- Patient has been diagnosed with Prostate Cancer as identified by imaging
- Patient has self-identified as planning to enroll in an interventional clinical trial for Prostate Cancer
- Patient is at least 18 years of age
Key exclusion criteria (3 listed)
- Patient does not understand, sign, and return consent form
- Inability to perform regular electronic reporting
- Patient has a ECOG score of 4
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
Rate of patients who decide to enroll in a Prostate Cancer Clinical Trial
Time frame: 3 months
Number of patients who remain in Prostate Cancer clinical trial until completion of clinical trial
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 2 Jan 2024.
- Background: PubMed 33835826McKay RR, Gold T, Zarif JC, Chowdhury-Paulino IM, Friedant A, Gerke T, Grant M, Hawthorne K, Heath E, Huang FW, Jackson MD, Mahal B, Ogbeide O, Paich K, Ragin C, Rencsok EM, Simmons S, Yates C, Vinson J, Kantoff PW, George DJ, Mucci LA. Tackling Diversity in Prostate Cancer Clinical Trials: A Report From the Diversity Working Group of the IRONMAN Registry. JCO Glob Oncol. 2021 Apr;7:495-505. doi: 10.1200/GO.20.00571.
- Background: PubMed 32503813Rencsok EM, Bazzi LA, McKay RR, Huang FW, Friedant A, Vinson J, Peisch S, Zarif JC, Simmons S, Hawthorne K, Villanti P, Kantoff PW, Heath E, George DJ, Mucci LA. Diversity of Enrollment in Prostate Cancer Clinical Trials: Current Status and Future Directions. Cancer Epidemiol Biomarkers Prev. 2020 Jul;29(7):1374-1380. doi: 10.1158/1055-9965.EPI-19-1616. Epub 2020 Jun 5.
- Individual participant dataSharing planned: Undecided
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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 Science 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 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 2 Jan 2024. 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 (415-287-9919, bask@withpower.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients who decide to enroll in a Prostate Cancer Clinical Trial (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 NCT05411354, which also lists 2 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 2 Jan 2024.