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Androgen Receptor Antagonist
Relugolix + Darolutamide for Prostate Cancer
Phase 2
Waitlist Available
Led By Atish Choudhury, MD, PhD
Research Sponsored by Atish Choudhury, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must be age ≥18 years
Participants must have histologically or cytologically confirmed prostate cancer
Must not have
Participants with uncontrolled intercurrent illness
Pregnant and nursing women
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 29 days. pharmacokinetic (pk) collection prior to the first dose of both drugs and then after 2 hours, 4 hours and 8 hours (cohort 1) or after 24 hours, 7 days, and 28 days (cohort 2) of uninterrupted dosing during cycle 1 (each cycle is 28 days).
Awards & highlights
Summary
This trial is looking at how quickly testosterone levels return to normal after two years of treatment with a combination of two drugs, Relugolix and Darolutamide. The study also aims to determine if
Who is the study for?
This trial is for men with prostate cancer who have completed two years of treatment. It's designed to see how quickly testosterone levels return to normal after stopping the drugs relugolix and darolutamide, which are used together in this study.
What is being tested?
The study tests the combination of two medications: Relugolix, which reduces certain hormone production, and Darolutamide, which blocks hormones that can fuel cancer growth. The focus is on recovery rates of testosterone after treatment.
What are the potential side effects?
Possible side effects include hot flashes, fatigue, joint pain, high blood pressure, diarrhea or constipation. There may also be risks related to changes in liver enzymes or other lab values.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My prostate cancer diagnosis was confirmed through lab tests.
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I am fully active and can carry on all my pre-disease activities without restriction.
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My organ and bone marrow functions meet the required levels.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any unmanaged ongoing illnesses.
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I am currently pregnant or breastfeeding.
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My PSA levels have increased even though my testosterone levels are very low.
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My cancer has spread to my brain or other vital organs.
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I am taking medication that may not mix well with darolutamide or relugolix.
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I have another active cancer besides the one being studied.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 29 days. pharmacokinetic (pk) collection prior to the first dose of both drugs and then after 2 hours, 4 hours and 8 hours (cohort 1) or after 24 hours, 7 days, and 28 days (cohort 2) of uninterrupted dosing during cycle 1 (each cycle is 28 days).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~29 days. pharmacokinetic (pk) collection prior to the first dose of both drugs and then after 2 hours, 4 hours and 8 hours (cohort 1) or after 24 hours, 7 days, and 28 days (cohort 2) of uninterrupted dosing during cycle 1 (each cycle is 28 days).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
18-month Rate of Testosterone Recovery
Grade 3-5 Treatment-related Toxicity Rate
Secondary outcome measures
Geometric Mean Ratio of Single-dose Cmax (highest concentration of drug) and Steady-state Ctrough (the concentration of drug in the blood immediately before the next dose is administered)
Mean Functional Assessment of Cancer Therapy - Prostate (FACT-P) Score
Rate of Treatment Discontinuation
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort 2 Long Pharmacokinetics (PK)Experimental Treatment2 Interventions
Enrolled participants will complete study procedures as follows:
Cycle 1:
Days 1, 2, 8 of 28 Day Cycle: Predetermined dose of Relugolix 1x daily. First dose will be administered in-clinic.
Days 1, 2, 8 of 28 Day Cycle: Predetermined dose of Darolutamide 2x daily. First dose will be administered in-clinic.
Cycle 2:
Day 1 of 28 Day Cycle: Predetermined dose of Relugolix 1x daily. First dose will be administered in-clinic.
Day 1 of 28 Day Cycle: Predetermined dose of Darolutamide 2x daily. First dose will be administered in-clinic.
Cycle 3 through End of Treatment:
Predetermined dose of Relugolix 1x daily.
Predetermined dose of Darolutamide 2x daily.
End of Treatment visit.
Follow Up: every 3 months for 18 months.
Group II: Cohort 1 Short Pharmacokinetics (PK)Experimental Treatment2 Interventions
Enrolled participants will complete study procedures as follows:
Cycle 1:
Day 1 of 28 Day Cycle: Predetermined dose of Relugolix 1x daily. First dose will be administered in-clinic.
Day 1 of 28 Day Cycle: Predetermined dose of Darolutamide 2x daily. First dose will be administered in-clinic.
Cycle 2 through End of Treatment:
Predetermined dose of Relugolix 1x daily.
Predetermined dose of Darolutamide 2x daily.
End of Treatment visit.
Follow Up: every 3 months for 18 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Darolutamide
2018
Completed Phase 2
~100
Relugolix
2016
Completed Phase 3
~5360
Find a Location
Who is running the clinical trial?
Atish Choudhury, MDLead Sponsor
BayerIndustry Sponsor
2,251 Previous Clinical Trials
25,336,883 Total Patients Enrolled
41 Trials studying Prostate Cancer
26,091 Patients Enrolled for Prostate Cancer
PfizerIndustry Sponsor
4,595 Previous Clinical Trials
12,868,737 Total Patients Enrolled
43 Trials studying Prostate Cancer
12,870 Patients Enrolled for Prostate Cancer
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