Clinical trial · Observational
A Multi-Center, Prospective, Observational Study of Patients Being Treated With ORGOVYX
NCT05467176CI-TRIAL-00117798OPTYXcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Relugolix | Drug | Relugolix | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- 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.
- interventionNames
- Drug: Relugolix
Primary outcomes (4)
- measure
- Demographics
- timeFrame
- Up to 5 years
- description
- Patient demographics
- measure
- Selective Safety Data
- timeFrame
- Up to 5 years
- description
- Incidence of treatment-related serious adverse events and any adverse events resulting in discontinuation of ORGOVYX as reported by physician or patient.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDSpratt DE, Dorff T, McKay RR, Lowentritt BH, Fallick M, Gatoulis SC, Flanders SC, Ross AE. Evaluating relugolix for the treatment of prostate cancer in real-world settings of care: the OPTYX study protocol. Future Oncol. 2024 Apr;20(12):727-738. doi: 10.2217/fon-2023-0748. Epub 2024 Mar 15. PMID 38488039