A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Myovant Sciences GmbH
Study ID
NCT03085095
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Relugolix — DRUG
    Relugolix 120-mg tablet administered orally once daily following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1
  • Leuprolide Acetate — DRUG
    Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan, Taiwan, and China), every 3 months by subcutaneous injection

Study Details

The purpose of this study is to determine the efficacy and safety of relugolix 120 milligrams (mg) orally once daily for 48 weeks on maintaining serum testosterone suppression to castrate levels (\< 50 nanograms/deciliter \[ng/dL\]) in participants with androgen-sensitive advanced prostate cancer.

Key Dates

Start date
Apr 18, 2017
Status verified
Jan 2022
Primary completion
Oct 25, 2019
Completion
Nov 26, 2021

Study Design

Enrollment
1,134 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Relugolix
    Relugolix for 48 weeks
  • Active Comparator: Leuprolide Acetate
    Leuprolide acetate for 48 weeks

Primary Outcome Measure

Sustained Castration Rate [ Time Frame: From Week 5 Day 1 (Day 29) to Week 49 Day 1 (Day 337) ]

Locations (27)

FacilityCityStateZIPSite coordinators
TucsonTucsonArizona85741-
OrangeOrangeCalifornia92868-
DenverDenverColorado80211-
Pompano BeachPompano BeachFlorida33060-
JeffersonvilleJeffersonvilleIndiana47130-
Des MoinesDes MoinesIowa50266-
WichitaWichitaKansas67226-
BaltimoreBaltimoreMaryland21204-
TroyTroyMichigan48084-
OmahaOmahaNebraska68130-
Las VegasLas VegasNevada89135-
BrickBrickNew Jersey08724-
AlbuquerqueAlbuquerqueNew Mexico87109-
AlbanyAlbanyNew York12208-
Garden CityGarden CityNew York11530-
PlainviewPlainviewNew York11803-
PoughkeepsiePoughkeepsieNew York12601-
SyracuseSyracuseNew York13210-
DurhamDurhamNorth Carolina27710-
GreensboroGreensboroNorth Carolina27403-
CincinnatiCincinnatiOhio45212-
Middleburg HeightsMiddleburg HeightsOhio44130-
Oklahoma CityOklahoma CityOklahoma73104-
LancasterLancasterPennsylvania17604-
Myrtle BeachMyrtle BeachSouth Carolina29572-
NashvilleNashvilleTennessee37209-
San AntonioSan AntonioTexas78258-

Find similar trials in Tucson, AZ

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Tucson· Tucson, AZOrange· Orange, CADenver· Denver, COPompano Beach· Pompano Beach, FLJeffersonville· Jeffersonville, INDes Moines· Des Moines, IA

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