Comeback From Long coursE Androgen Deprivation Therapy (ADT) With RElugolix and Darolutamide (CLEARED)

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Atish Choudhury, MD
Study ID
NCT06463457
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Darolutamide — DRUG
    Androgen receptor antagonist, tablet taken orally per protocol.
  • Relugolix — DRUG
    Gonadotropin-releasing hormone (GnRH) receptor antagonist, tablet taken orally per protocol.

Study Details

This research study is being done to determine the rate of testosterone recovery after completing two years of treatment with the combination of relugolix and darolutamide as well as to assess the safety of the drugs when administered in combination. The names of the drugs in this study are: * Relugolix (a type of gonadotropin-releasing hormone receptor antagonist) * Darolutamide (a type of androgen receptor antagonist)

Key Dates

Start date
Dec 13, 2024
Status verified
Mar 2026
Primary completion
Nov 30, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
33 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1 Short Pharmacokinetics (PK)
    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.
  • Experimental: Cohort 2 Long Pharmacokinetics (PK)
    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.

Primary Outcome Measure

18-month Rate of Testosterone Recovery [ Time Frame: 42 months (18 months after completion of 2 years of treatment) ]

Locations (3)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Brigham and Women's HospitalBostonMassachusetts02215-
Dana-Farber Cancer InstituteBostonMassachusetts02215-

Find similar trials in Boston, MA

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By research site
Beth Israel Deaconess Medical Center· Boston, MABrigham and Women's Hospital· Boston, MADana-Farber Cancer Institute· Boston, MA

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