Recurrent Prostate CancerNCT06070272
Determining Patterns In Trial Experiences of Recurrent Prostate Cancer Patients
An observational study of Recurrent Prostate Cancer, run by Power Life Sciences Inc. at 1 site in United States.
Trial summary
Clinical studies, with a dedicated focus on recurrent prostate cancer, play a pivotal role in evaluating the safety and effectiveness of novel treatments for this condition. These trials serve as essential tools to determine whether new medications outperform traditional therapies, providing substantial evidence to… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Recurrent Prostate Cancer
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2024to Oct 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 recurrent 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 recurrent 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: Investigating the Dynamics of Patient Engagement and Trends in Participation in Recurrent Prostate Cancer Clinical Trials
Clinical studies, with a dedicated focus on recurrent prostate cancer, play a pivotal role in evaluating the safety and effectiveness of novel treatments for this condition.
These trials serve as essential tools to determine whether new medications outperform traditional therapies, providing substantial evidence to endorse their broader utilization.
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 recurrent prostate cancer.
- Conditions
- Recurrent Prostate Cancer
- Keywords
- Recurrent 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 recurrent prostate cancer clinical research
Measured: 3 months
Rate of patients who remain in recurrent 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 posted6 Oct 2023
- Study startOct 2024 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionOct 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 Recurrent 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
- NCT06070272
- Sponsor's protocol ID
- 72630763
- Status last verified
- Sep 2023
- First submitted
- 30 Sep 2023
- Last updated
- 6 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hefermehl LJ, Disteldorf D, Lehmann K. Acknowledging unreported problems with active surveillance for prostate cancer: a prospective single-centre observational study. BMJ Open. 2016 Feb 17;6(2):e010191. doi: 10.1136/bmjopen-2015-010191.
PubMed 26888730Wollersheim BM, Helweg E, Tillier CN, van Muilekom HAM, de Blok W, van der Poel HG, van Asselt KM, Boekhout AH. The role of routine follow-up visits of prostate cancer survivors in addressing supportive care and information needs: a qualitative observational study. Support Care Cancer. 2021 Nov;29(11):6449-6457. doi: 10.1007/s00520-021-06222-9. Epub 2021 Apr 26.
PubMed 33900459Ye D, Zhang W, Ma L, Du C, Xie L, Huang Y, Wei Q, Ye Z, Na Y. Adjuvant hormone therapy after radical prostatectomy in high-risk localized and locally advanced prostate cancer: First multicenter, observational study in China. Chin J Cancer Res. 2019 Jun;31(3):511-520. doi: 10.21147/j.issn.1000-9604.2019.03.13.
PubMed 31354220
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Dynamics of Patient Engagement and Trends in Participation in Recurrent Prostate Cancer Clinical Trials
- ClinicalTrials.gov ID
- NCT06070272
- Acronym / sponsor ID
- 72630763
- Conditions
- Recurrent Prostate Cancer
- Keywords
- Recurrent 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
- Oct 2024 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 6 Oct 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.
Clinical studies, with a dedicated focus on recurrent prostate cancer, play a pivotal role in evaluating the safety and effectiveness of novel treatments for this condition.
These trials serve as essential tools to determine whether new medications outperform traditional therapies, providing substantial evidence to endorse their broader utilization.
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 recurrent 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 recurrent 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 recurrent 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 recurrent prostate cancer clinical research
Time frame: 3 months
Rate of patients who remain in recurrent 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 6 Oct 2023.
- Background: PubMed 26888730Hefermehl LJ, Disteldorf D, Lehmann K. Acknowledging unreported problems with active surveillance for prostate cancer: a prospective single-centre observational study. BMJ Open. 2016 Feb 17;6(2):e010191. doi: 10.1136/bmjopen-2015-010191.
- Background: PubMed 33900459Wollersheim BM, Helweg E, Tillier CN, van Muilekom HAM, de Blok W, van der Poel HG, van Asselt KM, Boekhout AH. The role of routine follow-up visits of prostate cancer survivors in addressing supportive care and information needs: a qualitative observational study. Support Care Cancer. 2021 Nov;29(11):6449-6457. doi: 10.1007/s00520-021-06222-9. Epub 2021 Apr 26.
- Background: PubMed 31354220Ye D, Zhang W, Ma L, Du C, Xie L, Huang Y, Wei Q, Ye Z, Na Y. Adjuvant hormone therapy after radical prostatectomy in high-risk localized and locally advanced prostate cancer: First multicenter, observational study in China. Chin J Cancer Res. 2019 Jun;31(3):511-520. doi: 10.21147/j.issn.1000-9604.2019.03.13.
- 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 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 Recurrent 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 6 Oct 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 recurrent 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 NCT06070272, 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 6 Oct 2023.