A Multi-Center, Prospective, Observational Study of Patients Being Treated With ORGOVYX (OPTYX)

Sumitomo Pharma

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Drug: Relugolix

Study type: Observational

Funder types: Industry

Identifiers

NCT05467176

MVT-601-058

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,000 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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

Trial design

1,000 participants in 1 patient group

Participants with Prostate Cancer

Description:

Patients with prostate cancer who are initiating treatment or have initiated treatment with ORGOVYX (per label instructions) within 1 month prior to enrollment and who remain on treatment at the time of enrollment.

Treatment:

Drug: Relugolix