RecoverPC: Relugolix vs GnRH Agonist in Quality of Life

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT05765500
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Relugolix — DRUG
    Gonadotropin-releasing hormone (GnRH) antagonist, oral tablet taken 1x daily.
  • Leuprolide — DRUG
    Gonadotropin-releasing hormone (GnRH) antagonist, intramuscular injection 1x every 3 months.

Study Details

This study is testing the way that approved androgen deprivation therapy treatments, Leuprolide and Relugolix, for prostate cancer affect quality of life, blood levels, cholesterol, and blood sugar. The drugs are already standard treatment for people with prostate cancer, and the drugs will be used as described in their label. The names of the study drugs involved in this study are: * Leuprolide (type of ADT) * Relugolix (type of ADT)

Key Dates

Start date
Feb 12, 2024
Status verified
Apr 2025
Primary completion
Jul 1, 2027
Completion
Jan 1, 2028

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Relugolix
    55 participants will be randomized in a 1:1 fashion to Relugolix and stratified by intent to treat with radiation and will complete study procedures as outlined: * Surveys at baseline and at months 3, 6, 9, and 12. * Medication diary entries. * Cycles 1 - 6: --Days 1 - 28 of 28 day cycle: Predetermined dose of Relugolix. Participant will self-administer at home. * Follow up visits every 3 months for 12 months.
  • Active Comparator: Arm B: Leuprolide
    55 participants will be randomized in a 1:1 fashion to Leuprolide and stratified by intent to treat with radiation and will complete study procedures as outlined: * Surveys at baseline and at months 3, 6, 9, and 12. * Cycle 1 and Cycle 4: --Day 1 of 28 day cycle: Predetermined dose of Leuprolide. Injection will be administered in clinic. * Follow up visits every 3 months for 12 months.

Primary Outcome Measure

9-month Quality of Life (QOL) Score [ Time Frame: At 9 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02215
Alicia Morgans, MD
[email protected]
857-215-1605
Dana-Farber Cancer InstituteBostonMassachusetts02215
Alicia Morgans, MD
[email protected]
857-215-1605
Dana-Farber Cancer Institute at FoxboroughFoxboroughMassachusetts02035
Daniel Roberts, MD
[email protected]
508-543-1700

Find similar trials in Boston, MA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Brigham and Women's Hospital· Boston, MADana-Farber Cancer Institute· Boston, MADana-Farber Cancer Institute at Foxborough· Foxborough, MA

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