Study of Relugolix in Men With Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Sumitomo Pharma America, Inc.
Study ID
NCT04666129
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Relugolix — DRUG
    (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 — DRUG
    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.
  • Prednisone — DRUG
    (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.
  • Methylprednisolone — DRUG
    For participants with mCRPC taking fine-particle abiraterone acetate, methylprednisolone 4 mg will be administered orally twice daily.
  • Apalutamide — DRUG
    Apalutamide 240 mg (4 x 60-mg tablets) will be administered orally once daily.
  • Docetaxel — DRUG
    Docetaxel 75 mg/m2 dose will be administered every 3 weeks as a 1-hour intravenous infusion.

Study Details

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).

Key Dates

Start date
Feb 18, 2021
Status verified
Aug 2025
Primary completion
May 28, 2024
Completion
May 28, 2024

Study Design

Enrollment
48 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Relugolix plus Abiraterone plus a Corticosteroid
    Participants will receive relugolix in combination with abiraterone plus a corticosteroid for 12 weeks during the study treatment period.
  • Experimental: Part 2: Relugolix plus Apalutamide
    Participants will receive relugolix in combination with apalutamide for 12 weeks during the study treatment period.
  • Experimental: Part 3: Relugolix plus Docetaxel with or without Prednisone
    Participants will receive relugolix in combination with docetaxel with or without prednisone for 12 weeks during the study treatment period.

Primary Outcome Measure

Incidence of Adverse Events [ Time Frame: Baseline through Week 13 ]

Locations (16)

FacilityCityStateZIPSite coordinators
Urological Associates of Southern Arizona, P.C.TucsonArizona85741-
Arkansas UrologyLittle RockArkansas72211-
Colorodo Clinical ResearchLakewoodColorado80228-
Chesapeake Urology Research AssociatesBaltimoreMaryland21204-
University of Massachusetts Medical SchoolWorcesterMassachusetts01655-
New Jersey UrologySaddle BrookNew Jersey07663-
Clinical Research Alliance, Inc.WestburyNew York11590-
Alliance UrologyGreensboroNorth Carolina27403-
Wake Forest Baptist HealthWinston-SalemNorth Carolina27157-
Helios Clinical Research, LLC.Middleburg HeightsOhio44130-
Center for Advanced Urology, LLP d/b/a: MidLantic UrologyBala-CynwydPennsylvania19004-
Keystone Urology SpecialistsLancasterPennsylvania17604-
Carolina Urologic Research CenterMyrtle BeachSouth Carolina29572-
Urology Associates, P.C.NashvilleTennessee37209-
UT Southwestern Medical CenterDallasTexas75390-
Urology San AntonioSan AntonioTexas78229-

Find similar trials in Tucson, AZ

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Urological Associates of Southern Arizona, P.C.· Tucson, AZArkansas Urology· Little Rock, ARColorodo Clinical Research· Lakewood, COChesapeake Urology Research Associates· Baltimore, MDUniversity of Massachusetts Medical School· Worcester, MANew Jersey Urology· Saddle Brook, NJ

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