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GnRH Receptor Antagonist
Relugolix for Prostate Cancer
Phase 1
Recruiting
Research Sponsored by Myovant Sciences 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
Study Summary
This trial is testing a new drug to see if it's safe and effective for treating prostate cancer.
Eligible Conditions
- Metastatic Castration Sensitive Prostate Cancer
- Prostate Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (day 1), week 3, week 5, week 9, and week 13
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1), week 3, week 5, week 9, and week 13
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
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 moreSide effects data
From 2020 Phase 3 trial • 388 Patients • NCT0304973511%
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)
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
Apalutamide
2015
Completed Phase 2
~3310
Prednisone
2014
Completed Phase 4
~2370
Relugolix
2016
Completed Phase 3
~5360
Abiraterone
2012
Completed Phase 4
~2830
Methylprednisolone
2015
Completed Phase 4
~2280
Docetaxel
1995
Completed Phase 4
~5620
Find a Location
Who is running the clinical trial?
Myovant Sciences GmbHLead Sponsor
22 Previous Clinical Trials
12,418 Total Patients Enrolled
6 Trials studying Prostate Cancer
4,644 Patients Enrolled for Prostate Cancer
Myovant Medical MonitorStudy DirectorMyovant Sciences
9 Previous Clinical Trials
5,487 Total Patients Enrolled
2 Trials studying Prostate Cancer
2,134 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have any other health or mental condition that the doctor thinks might make it difficult for you to participate in the study or complete it.Your symptoms are getting worse.You have had cancer spread to your brain or liver, or you have had your testicles surgically removed.You have a history of bleeding disorder or currently experiencing bleeding in your stomach or from another part of your body.You have an increase in PSA of at least 2.0 ng/ml over a period of at least 1 week.Radiologic evidence demonstrating enlarged metastatic lesions or the development of new metastases.You are currently receiving a specific type of treatment called leuprolide acetate or a GnRH receptor antagonist, along with either abiraterone acetate, apalutamide, or docetaxel.You have ≥ 2 metastatic lesions on bone scan.
Research Study Groups:
This trial has the following groups:- Group 1: Part 3: Relugolix plus Docetaxel with or without Prednisone
- Group 2: Part 1: Relugolix plus Abiraterone plus a Corticosteroid
- Group 3: Part 2: Relugolix plus Apalutamide
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there any availability for volunteers in this medical experiment?
"This trial is currently seeking volunteers. Its original posting date was February 18th 2021, with the most recent information being updated on September 2nd 2022, as stated by clinicaltrials.gov."
Answered by AI
Are there multiple sites within this state participating in the experiment?
"The 16 sites in operation for this trial include Urology San Antonio, Arkansas Urology, Carolina Urologic Research Centre and 13 other locations."
Answered by AI
To what medical issues is Relugolix typically prescribed?
"Relugolix is the recommended course of action for treating metastatic bladder cancer. It can also be used to address conditions such as ophthalmia, sympathetic, scalp structure and small cell lung cancer (SCLC)."
Answered by AI
Has Relugolix been sanctioned by the Food and Drug Administration?
"As this is an early-phase clinical trial, there are only limited safety and efficacy data available. Thus, Relugolix’s risk rating has been assessed as a 1 on our evaluation scale of 1 to 3."
Answered by AI
What is the upper bound of participants involved in this research endeavor?
"Indeed, according to clinicaltrials.gov, this research project is still hunting for participants. It was initially posted on February 18th 2021 and recently updated on September 2nd 2022; it seeks out 72 patients at 16 sites."
Answered by AI
Who else is applying?
What state do they live in?
Pennsylvania
How old are they?
65+
What site did they apply to?
Center for Advanced Urology, LLP d/b/a: MidLantic Urology
What portion of applicants met pre-screening criteria?
Met criteria
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