Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
completion around

Description

Summary

This is a multi-center, prospective, observational study of patients being treated with ORGOVYX. The goal of this study is to generate real-world evidence about the safety and effectiveness of ORGOVYX in patients with prostate cancer in routine clinical care and the clinical course during treatment with and following cessation of ORGOVYX.

Details

This prospective observational cohort study will be conducted in patients who are initiating treatment or have initiated treatment with ORGOVYX within the 1 month prior to the time of study enrollment and who remain on treatment at the time of enrollment. The decision to initiate treatment with ORGOVYX should be made prior to study enrollment. The study is designed to better understand the actual experience of patients with prostate cancer treated with ORGOVYX by collecting data on treatment patterns, adherence, and selective safety data. Additionally, a better understanding of the trajectory of patients with prostate cancer following cessation of ORGOVYX therapy will be gained by observing the clinical course of the disease, health outcomes, and health-related quality-of-life (HRQoL) in these patients.

Keywords

Prostate Cancer, relugolix, ORGOVYX, OPTYX, Prostatic Neoplasms

Eligibility

You can join if…

Open to males ages 18 years and up

  • Patients who are diagnosed with prostate cancer and initiating treatment with ORGOVYX at the time of enrollment or within 1 month prior to enrollment and who remain on treatment at enrollment
  • Patients who are willing and able to complete PRO assessments during the study
  • Patients who have reviewed and signed the informed consent form (ICF)

You CAN'T join if...

  • Patients with a history of surgical castration
  • Patients with a medical or psychiatric condition that precludes participation in the opinion of the treating physician
  • Patients whose original treatment plan is intended to be less than a total of 4 months of ORGOVYX

Locations

  • UCSD
    La Jolla California 92097 United States
  • Tower Urology
    Los Angeles California 90048 United States
  • Urology Associates of Central California
    Fresno California 93720 United States
  • Genesis Research LLC
    San Diego California 92123 United States
  • USC Norris Cancer Center
    Los Angeles California 90033 United States
  • VA Greater Los Angeles Medical Center
    Los Angeles California 90073 United States
  • City of Hope
    Duarte California 91010 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Sumitomo Pharma Switzerland GmbH
ID
NCT05467176
Study Type
Observational
Participants
About 999 people participating
Last Updated