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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

No Placebo-Only Group

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 below

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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:

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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).

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

18-month Rate of Testosterone Recovery

Grade 3-5 Treatment-related Toxicity Rate

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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