NCT05411354

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Sep 2024Sep 2026

First Submitted

Initial submission to the registry

June 5, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 9, 2022

Completed
2.2 years until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

January 2, 2024

Status Verified

December 1, 2023

Enrollment Period

1 year

First QC Date

June 5, 2022

Last Update Submit

December 29, 2023

Conditions

Keywords

Prostate CancerProstateProstate Clinical Trials

Outcome Measures

Primary Outcomes (2)

  • Rate of patients who decide to enroll in a Prostate Cancer Clinical Trial

    3 months

  • Number of patients who remain in Prostate Cancer clinical trial until completion of clinical trial

    12 months

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Power Life Sciences

San Francisco, California, 94107, United States

Location

Related Publications (2)

  • 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.

    PMID: 33835826BACKGROUND
  • 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.

    PMID: 32503813BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Michael B Gill

    Power Life Science Inc

    STUDY DIRECTOR

Central Study Contacts

Michael B Gill

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2022

First Posted

June 9, 2022

Study Start

September 1, 2024

Primary Completion

September 1, 2025

Study Completion (Estimated)

September 1, 2026

Last Updated

January 2, 2024

Record last verified: 2023-12

Locations