Clinical trial NCT06009549: A Journey Into Participation Patterns Among Metastatic Prostate Cancer Patients
Official title: Engagement Trends in Clinical Trials for Metastatic Prostate Cancer - A Journey Into Participation Patterns Among Individuals Affected by the Condition
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Metastatic Prostate Cancer
Keywords: metastatic prostate cancer
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-24
Enrollment: 500
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with metastatic prostate cancer who are actively considering enrolling in a clinical study, but have not yet completed enrollment and randomization.

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Enrolled in another research study
* Patients with psychiatric illness/social situations that would limit compliance with study requirements
* Inability to provide written informed consent

Primary outcomes:
measure: Number of patients who decide to participate in a metastatic prostate cancer clinical research
timeFrame: 3 months
measure: Rate of patients who remain in metastatic prostate cancer clinical research to trial completion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Power Life Sciences
state: California
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Vlaming 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.
citation: Presti 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.