Trial Title:
RecoverPC: Relugolix vs GnRH Agonist in Quality of Life
NCT ID:
NCT05765500
Condition:
Prostate Cancer
Prostatic Neoplasms
Conditions: Official terms:
Prostatic Neoplasms
Leuprolide
Relugolix
Conditions: Keywords:
Prostate Cancer
Prostate Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Drug
Intervention name:
Relugolix
Description:
Gonadotropin-releasing hormone (GnRH) antagonist, oral tablet taken 1x daily.
Arm group label:
Arm A: Relugolix
Other name:
Orgovyx
Intervention type:
Drug
Intervention name:
Leuprolide
Description:
Gonadotropin-releasing hormone (GnRH) antagonist, intramuscular injection 1x every 3
months.
Arm group label:
Arm B: Leuprolide
Other name:
Leuprolide Depot
Summary:
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)
Detailed description:
This is a phase 2 clinical trial comparing patient-reported Quality of Life (QOL) among
men with localized or biochemically recurrent prostate cancer treated with relugolix
versus leuprolide depot therapy.
Participants will be randomized into one of the study groups leuprolide versus relugolix.
Randomization means that a participant is put into a study group by chance.
The U.S. Food and Drug Administration (FDA) has approved leuprolide and relugolix as
treatment options for prostate cancer.
The research study procedures include screening for eligibility and study treatment
including evaluations and follow up visits, ECGs, and blood tests.
Participation in this research study is expected to last 12 months.
It is expected about 110 people will take part in this research study.
The Prostate Cancer Foundation and Pfizer are supporting this research study by providing
funding. Myovant is supporting this study by providing the drug, Relugolix.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Participants must have a histologic diagnosis of prostate adenocarcinoma.
- Participants must be eligible for treatment with 6 months of ADT with leuprolide
depot or relugolix without additional systemic therapies other than first generation
androgen receptor antagonists (eg. bicalutamide, nilutamide, flutamide).
- Participants cannot have received prior GnRH agonist or antagonist therapy.
- Patients must have testosterone level > 200 ng/mL prior to initiation of ADT.
- Age ≥18 years.
- ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).
- Life expectancy of greater than 12 months
- Participants must have adequate organ and marrow function as defined below:
- leukocytes ≥3,000/mcL
- absolute neutrophil count ≥1,500/mcL
- platelets ≥100,000/mcL
- total bilirubin ≤ institutional upper limit of normal (ULN) unless known or
suspected Gilbert syndrome
- AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN
- creatinine ≤ institutional ULN OR
- glomerular filtration rate (GFR) ≥50 mL/min/1.73 m2 unless data exists
supporting safe use at lower kidney function values, no lower than 30
mL/min/1.73 m2 (see Appendix B).
- Human immunodeficiency virus (HIV)-infected participants on effective
anti-retroviral therapy with undetectable viral load within 6 months are eligible
for this trial.
- For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV
viral load must be undetectable on suppressive therapy, if indicated.
- Participants with a history of hepatitis C virus (HCV) infection must have been
treated and cured. For participants with HCV infection who are currently on
treatment, they are eligible if they have an undetectable HCV viral load.
- Participants with a prior or concurrent malignancy whose natural history or
treatment does not have the potential to interfere with the safety or efficacy
assessment of the investigational regimen are eligible for this trial.
- Participants with known history or current symptoms of cardiac disease, or history
of treatment with cardiotoxic agents, should have a clinical risk assessment of
cardiac function using the New York Heart Association Functional Classification. To
be eligible for this trial, participants should be class 2B or better.
- The effects of relugolix and leuprolide on the developing human fetus are unknown.
For this reason and because GnRH agents are known to be teratogenic, women of
child-bearing potential and men must agree to use adequate contraception (hormonal
or barrier method of birth control; abstinence) prior to study entry and for the
duration of study participation. Should a woman become pregnant or suspect she is
pregnant while she or her partner is participating in this study, she should inform
her treating physician immediately. Men treated or enrolled on this protocol must
also agree to use adequate contraception prior to the study, for the duration of
study participation, and 4 months after completion of relugolix or leuprolide depot
administration.
- Ability to understand and the willingness to sign a written informed consent
document.
Exclusion Criteria:
- History of major adverse cardiac event, including myocardial infarction, new
congestive heart failure (CHF) or CHF exacerbation, or stroke, within the past 6
months.
- Participants who have prior or planned concurrent treatment with second generation
AR targeted therapies (such as abiraterone, enzalutamide, darolutamide,
apalutamide).
- Participants who are receiving any other investigational agents.
- Patients with brain metastases will be excluded from the study as intermittent
hormonal therapy is not standard of care treatment for this population.
- History of allergic reactions attributed to compounds of similar chemical or
biologic composition to leuprolide depot or relugolix.
- Participants with uncontrolled intercurrent illness.
- Participant is unable to swallow pills.
Gender:
Male
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Brigham and Women's Hospital
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Alicia Morgans, MD
Phone:
857-215-1605
Email:
aliciak_morgans@dfci.harvard.edu
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alicia Morgans, MD
Phone:
857-215-1605
Email:
aliciak_morgans@dfci.harvard.edu
Facility:
Name:
Dana-Farber Cancer Institute at Foxborough
Address:
City:
Foxboro
Zip:
02035
Country:
United States
Status:
Recruiting
Contact:
Last name:
Daniel Roberts, MD
Phone:
508-543-1700
Email:
Daniel_Roberts@DFCI.HARVARD.EDU
Start date:
February 12, 2024
Completion date:
January 1, 2026
Lead sponsor:
Agency:
Dana-Farber Cancer Institute
Agency class:
Other
Collaborator:
Agency:
Prostate Cancer Foundation
Agency class:
Other
Collaborator:
Agency:
Pfizer
Agency class:
Industry
Collaborator:
Agency:
Myovant Sciences GmbH
Agency class:
Industry
Source:
Dana-Farber Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05765500
