Clinical trial NCT05411354: Analyzing Clinical Trial Experiences of Prostate Cancer Patients
Official title: Analyzing Clinical Trial Experiences of Prostate Cancer Patients To Determine How Trial Attributes Affect Completion Rates For Specific Demographic Groups
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Prostate
Prostate Clinical Trials
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2022-06-09
Enrollment: 400
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: 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.

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Patient does not understand, sign, and return consent form
* Inability to perform regular electronic reporting
* Patient has a ECOG score of 4

Primary outcomes:
measure: Rate of patients who decide to enroll in a Prostate Cancer Clinical Trial
timeFrame: 3 months
measure: Number of patients who remain in Prostate Cancer clinical trial until completion of clinical trial
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 Science Inc
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Rencsok 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.