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GnRH Receptor Antagonist

Relugolix for Prostate Cancer

Phase 1
Waitlist Available
Research Sponsored by Sumitomo Pharma Switzerland GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1), week 3, week 5, week 9, and week 13
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug to see if it's safe and effective for treating prostate cancer.

Who is the study for?
Men with prostate cancer that's either spreading and sensitive to hormone therapy (mCSPC) or not spreading/resistant to hormone therapy (nmCRPC/mCRPC). They must have a Gleason score of ≥6, worsening symptoms, and evidence of disease progression. Participants should be on standard ADT treatments and tolerate certain drugs well without major side effects like liver damage or severe allergic reactions.
What is being tested?
The trial is testing the safety of Relugolix combined with other approved prostate cancer treatments over a period of 52 weeks. It aims to see how well patients handle this combination when added to their ongoing androgen deprivation therapy.
What are the potential side effects?
Potential side effects may include typical reactions from hormone therapies such as hot flashes, fatigue, gastrointestinal issues, skin rash, potential liver problems due to medications like abiraterone acetate, bone health concerns from apalutamide use, and possible blood cell count changes related to docetaxel.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1), week 3, week 5, week 9, and week 13
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1), week 3, week 5, week 9, and week 13 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Apalutamide and N-desmethyl Apalutamide Trough Concentrations at Baseline (Day 1), Week 3, Week 5, Week 9, and Week 13
Docetaxel Concentrations at Baseline (Day 1), In-Cycle, Mid-Treatment, and Week 13 in Each Infusion Cycle for Docetaxel
Incidence of Adverse Events
+6 more

Side effects data

From 2020 Phase 3 trial • 388 Patients • NCT03049735
11%
Hot flush
11%
Headache
5%
Hypertension
3%
Arthralgia
1%
Upper respiratory tract infection
1%
Avulsion fracture
1%
Ankle fracture
1%
Uterine myoma expulsion
1%
Haematemesis
1%
uterine leiomyoma
1%
Menorrhagia
1%
Pelvic pain
1%
Rhabdomyolysis
1%
Cough
1%
Vitreous detachment
1%
Hypothyroidism
100%
80%
60%
40%
20%
0%
Study treatment Arm
Relugolix Plus E2/NETA (Group A)
Relugolix Plus Delayed E2/NETA (Group B)
Placebo (Group C)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Part 3: Relugolix plus Docetaxel with or without PrednisoneExperimental Treatment3 Interventions
Participants will receive relugolix in combination with docetaxel with or without prednisone for 12 weeks during the study treatment period.
Group II: Part 2: Relugolix plus ApalutamideExperimental Treatment2 Interventions
Participants will receive relugolix in combination with apalutamide for 12 weeks during the study treatment period.
Group III: Part 1: Relugolix plus Abiraterone plus a CorticosteroidExperimental Treatment4 Interventions
Participants will receive relugolix in combination with abiraterone plus a corticosteroid for 12 weeks during the study treatment period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prednisone
2014
Completed Phase 4
~2500
Apalutamide
2015
Completed Phase 2
~5750
Relugolix
2016
Completed Phase 3
~5410
Abiraterone
2012
Completed Phase 4
~4480
Methylprednisolone
2015
Completed Phase 4
~2280
Docetaxel
1995
Completed Phase 4
~6550

Find a Location

Who is running the clinical trial?

Sumitomo Pharma Switzerland GmbHLead Sponsor
18 Previous Clinical Trials
6,892 Total Patients Enrolled
2 Trials studying Prostate Cancer
3,249 Patients Enrolled for Prostate Cancer
Myovant Sciences GmbHLead Sponsor
22 Previous Clinical Trials
12,414 Total Patients Enrolled
6 Trials studying Prostate Cancer
4,640 Patients Enrolled for Prostate Cancer
Mike UferStudy DirectorSumitomo Pharma America, Inc.
Myovant Medical MonitorStudy DirectorMyovant Sciences
9 Previous Clinical Trials
5,486 Total Patients Enrolled
2 Trials studying Prostate Cancer
2,133 Patients Enrolled for Prostate Cancer

Media Library

Relugolix (GnRH Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04666129 — Phase 1
Prostate Cancer Research Study Groups: Part 3: Relugolix plus Docetaxel with or without Prednisone, Part 1: Relugolix plus Abiraterone plus a Corticosteroid, Part 2: Relugolix plus Apalutamide
Prostate Cancer Clinical Trial 2023: Relugolix Highlights & Side Effects. Trial Name: NCT04666129 — Phase 1
Relugolix (GnRH Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04666129 — Phase 1
~10 spots leftby Dec 2025
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