A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer
The purpose of this study is to determine the benefit and safety of relugolix 120 mg orally once daily for 48 weeks on maintaining serum testosterone suppression to castrate levels (≤ 50 ng / dL [1.7 nmol / L] in participants with androgen-sensitive advanced prostate cancer.
- Has histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate;
- Is a candidate for, in the opinion of the investigator, at least 1 year of continuous androgen deprivation therapy for the management of androgen-sensitive advanced prostate cancer with one of the following clinical disease state presentations:
- Evidence of biochemical (PSA) or clinical relapse following local primary intervention with curative intent, such as surgery, radiation therapy, cryotherapy, or high-frequency ultrasound and not a candidate for salvage treatment by surgery; or
- Newly diagnosed androgen-sensitive metastatic disease; or
- Advanced localized disease unlikely to be cured by local primary intervention with either surgery or radiation with curative intent Note: Once 915 participants are enrolled worldwide only participants with metastatic advanced prostate cancer will be eligible for the study in all regions except China, where both metastatic and non-metastatic participants will continue to be enrolled.
- Has a serum testosterone at the Screening visit of ≥ 150 ng/dL (5.2 nmol/L);
- Has a serum PSA concentration at the Screening visit of > 2.0 ng/mL (2.0 μg/L), or, when applicable, post radical prostatectomy of > 0.2 ng/mL (0.2 μg/L) or post radiotherapy, cryotherapy, or high frequency ultrasound > 2.0 ng/mL (2.0 μg/L) above the post interventional nadir;
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at initial screening and at baseline.
- In the investigator's opinion, is likely to require chemotherapy or surgical therapy for symptomatic disease management within 2 months of initiating androgen deprivation therapy;
- Previously received gonadotropin-releasing hormone analog or other form of androgen deprivation therapy (estrogen or antiandrogen) for > 18 months total duration. If androgen deprivation therapy was received for ≤ 18 months total duration, then that therapy must have been completed at least 3 months prior to baseline. If the dosing interval of the depot is longer than 3 months, then the prior androgen deprivation therapy must have been completed at least as long as the dosing interval of the depot;
- Previous systemic cytotoxic treatment for prostate cancer (eg, taxane-based regimen);
- Metastases to brain per prior clinical evaluation;
- Scheduled for major surgery after baseline;
- History of surgical castration.
Locations & Contacts
Name Not Available
Trial Objectives and Outline
This study is an international phase 3 randomized, open-label, parallel group efficacy and safety study to evaluate oral daily relugolix 120 mg in participants with androgen-sensitive advanced prostate cancer who require at least 1 year (48 weeks) of continuous androgen deprivation therapy. Relugolix 120 mg orally once daily or leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in some Asian countries), every 3-months by subcutaneous or intramuscular injection will be administered to participants with prostate cancer who require androgen deprivation therapy. Approximately 1100 participants will be enrolled in this study, including approximately 390 participants with metastatic advanced prostate cancer to support the analysis of the secondary endpoint of time to castration-resistance and 138 Chinese participants (enrolled in China and Taiwan) to support registration in China. The study includes a Screening Period, a Treatment Period of 48 weeks, and a Follow-up Period. Additionally, unscheduled follow-up visit(s) may be arranged for participants with study-related safety concerns as needed. Eligible participants include those with evidence of biochemical relapse (rising prostate-specific antigen) following local primary intervention with curative intent, newly diagnosed metastatic disease (excluding metastases to the brain), and/or advanced localized disease. Following successful completion of the Screening period study participants will be randomized 2:1 to oral relugolix 120 mg once daily or leuprolide acetate 22.5 mg (or 11.25 mg in some Asian countries) 3-month depot subcutaneous or intramuscular injection and will attend visits monthly (every 4 weeks) where serum testosterone and prostate-specific antigen will be assessed. Safety will be assessed throughout the study by monitoring adverse events, vital signs, physical examinations, clinical laboratory tests, and 12-lead electrocardiograms.
Trial Phase & Type
Myovant Sciences GmbH
Secondary IDs NCI-2017-02302, 2017-000160-15
Clinicaltrials.gov ID NCT03085095