Clinical trial NCT06070272: Determining Patterns In Trial Experiences of Recurrent Prostate Cancer Patients
Official title: Investigating the Dynamics of Patient Engagement and Trends in Participation in Recurrent Prostate Cancer Clinical Trials
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Recurrent Prostate Cancer
Keywords: Recurrent Prostate Cancer
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-10-06
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 recurrent prostate cancer who are actively considering enrolling in a clinical study, but have not yet completed enrollment and randomization.

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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

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 recurrent prostate cancer clinical research
timeFrame: 3 months
measure: Rate of patients who remain in recurrent 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: 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.
citation: Wollersheim 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.
citation: Ye 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.