This study is being conducted to assess the safety and tolerability of relugolix with other agents approved for use in combination with androgen deprivation therapy (ADT) for a 12-week treatment period and an additional 40-week safety extension period in men with prostate cancer, either metastatic castration-sensitive prostate cancer (mCSPC) or non-metastatic or metastatic castration-resistant prostate cancer (nmCRPC or mCRPC).
This is a three-part, open-label, parallel-cohort study to assess the safety and tolerability of relugolix as the ADT component in combination treatment with abiraterone acetate plus a corticosteroid in patients with mCSPC or mCRPC (Part 1), apalutamide in patients with mCSPC or nmCRPC (Part 2), or docetaxel with or without prednisone in patients with mCSPC or mCRPC (Part 3). The study will consist of a 45-day screening period followed by a 12-week treatment period with one of the three combination treatments (Parts 1, 2, or 3). All participants are required to be currently or previously treated with a GnRH receptor antagonist (analog), leuprolide acetate or triptorelin, or a GnRH receptor antagonist, degarelix or relugolix, in combination with either abiraterone plus prednisone (Part 1), apalutamide (Part 2), or docetaxel (Part 3). The study consists of a 12-week primary study treatment period in which safety and tolerability, including assessment of vital sign measurements, ECGs, clinical laboratory tests and reporting of adverse events every 2 to 4 weeks, followed by a 40-week safety extension treatment period during which adverse events and changes to concomitant medications will be reported. The total treatment duration is 52 weeks.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
(Part 1 and Part 3) Relugolix will be administered orally as a single 360-milligram (mg) loading dose of 3 x 120-mg tablets, followed by a 120-mg dose (1 x 120-mg tablets), taken once daily at approximately the same time each day. (Part 2) Relugolix will be administered orally as a single 360-milligram (mg) loading dose of 3 x 120-mg tablets, followed by a 240-mg dose (2 x 120-mg tablets), taken once daily at approximately the same time each day.
Abiraterone acetate (1000 mg \[2 x 500-mg tablets\]) or fine-particle abiraterone acetate (500 mg \[4 x 125-mg tablets\]) will be administered orally once daily.
(Part 1 only) For participants with mCSPC, a 5-mg dose of prednisone will be administered orally once daily, and for participants with mCRPC, a 5-mg dose of prednisone will be administered orally twice daily. (Part 3 only) Prednisone 5 mg can be administered orally twice daily but is not required.
For participants with mCRPC taking fine-particle abiraterone acetate, methylprednisolone 4 mg will be administered orally twice daily.
Apalutamide 240 mg (4 x 60-mg tablets) will be administered orally once daily.
Docetaxel 75 mg/m2 dose will be administered every 3 weeks as a 1-hour intravenous infusion.
Urological Associates of Southern Arizona, P.C.
Tucson, Arizona, United States
Arkansas Urology
Little Rock, Arkansas, United States
Colorodo Clinical Research
Lakewood, Colorado, United States
Chesapeake Urology Research Associates
Baltimore, Maryland, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
New Jersey Urology
Saddle Brook, New Jersey, United States
Clinical Research Alliance, Inc.
Westbury, New York, United States
Alliance Urology
Greensboro, North Carolina, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
Helios Clinical Research, LLC.
Middleburg Heights, Ohio, United States
...and 6 more locations
Incidence of Adverse Events
Parts 1, 2, and 3
Time frame: Baseline through Week 13
Mean Testosterone Serum Concentrations at Baseline (Day 1), Week 5, and Week 13
Parts 1 and 2
Time frame: Baseline (Day 1), Week 5, and Week 13
Number and Proportion of Participants with Testosterone Concentrations ≥ 50 ng/dL at Baseline (Day 1), Week 5, and Week 13
Parts 1 and 2
Time frame: Baseline (Day 1), Week 5, and Week 13
Relugolix Trough Concentrations at Baseline (Day 1), Week 3, Week 5, Week 9, and Week 13
Part 2
Time frame: Baseline (Day 1), Week 3, Week 5, Week 9, and Week 13
Apalutamide and N-desmethyl Apalutamide Trough Concentrations at Baseline (Day 1), Week 3, Week 5, Week 9, and Week 13
Part 2
Time frame: Baseline (Day 1), Week 3, Week 5, Week 9, and Week 13
Mean Testosterone Serum Concentrations at Baseline (Day 1), Mid-Treatment, and Week 13
Part 3
Time frame: Baseline (Day 1), Mid-Treatment, and Week 13
Number and Proportion of Participants with Testosterone Concentrations ≥ 50 ng/dL at Baseline (Day 1), Mid-Treatment (Treatment Cycle that Most Closely Corresponds to Week 7 of the Primary Study Treatment Period), and Week 13
Part 3
Time frame: Baseline (Day 1), Mid-Treatment (Treatment Cycle that Most Closely Corresponds to Week 7 of the Primary Study Treatment Period), and Week 13
Relugolix Concentrations at Baseline (Day 1), In-Cycle, Mid-Treatment, and Week 13 in Each Infusion Cycle for Docetaxel
Part 3
Time frame: Baseline (Day 1), In-Cycle, Mid-Treatment, and Week 13 in Each Infusion Cycle for Docetaxel
Docetaxel Concentrations at Baseline (Day 1), In-Cycle, Mid-Treatment, and Week 13 in Each Infusion Cycle for Docetaxel
Part 3
Time frame: Baseline (Day 1), In-Cycle, Mid-Treatment, and Week 13 in Each Infusion Cycle for Docetaxel
Incidence of Adverse Events
Parts 1, 2, and 3
Time frame: Up to 52 weeks
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