Actively Recruiting
Relugolix + Enzalutamide Study in High-Risk Prostate Cancer
Led by University of Oklahoma · Updated on 2026-03-05
46
Participants Needed
1
Research Sites
261 weeks
Total Duration
On this page
Sponsors
U
University of Oklahoma
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to test how effective and safe it is to use a combination of two medications, relugolix and enzalutamide, in patients with advanced prostate cancer. We want to see if this combination can help improve the chances of curing the cancer and make the patients live longer without the cancer getting worse. The main questions we want to answer in this study are: * Can using relugolix and enzalutamide together help increase the chances of curing high-risk advanced prostate cancer? * Does this combination treatment help patients live longer without their cancer getting worse? Participants in this study will be asked to take relugolix and enzalutamide as part of their cancer treatment. They will also undergo Radiation Therapy or prostatectomy, which are standard treatments for this type of cancer.
CONDITIONS
Official Title
Relugolix + Enzalutamide Study in High-Risk Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide signed informed consent
- Male aged 18 years or older at time of consent
- Diagnosed with adenocarcinoma of the prostate with high-risk locally advanced disease defined by PSA >20 ng/mL or ISUP grade 4/5 (Gleason score >7) or clinical stage cT2c, or any PSA and ISUP grade with stage cT3-4 or cN+
- Normal organ and bone marrow function including platelets ≥100 × 103/µL, hemoglobin ≥10.0 g/dL, leukocytes ≥3 × 103/µL, absolute neutrophil count ≥1.5 × 103/µL, serum AST and ALT ≤2.5 × upper limit of normal, total bilirubin ≤1.5 × ULN (or <3x ULN if Gilbert's syndrome), serum creatinine ≤1.5 × ULN or creatinine clearance ≥30 mL/min if creatinine >1.5 × ULN
- ECOG performance status of 0 to 2
- Life expectancy of at least 6 months as judged by investigator
- Male patients willing to use contraception during treatment and for 3 months after last dose when sexually active with a pregnant woman or woman of childbearing potential, with female partners also using effective contraception if applicable
You will not qualify if you...
- History of major cardiac events including myocardial infarction, new or worsening congestive heart failure, or stroke within past 6 months
- Currently receiving any other investigational agents
- Presence of distant metastatic cancer
- Active secondary cancers requiring treatment
- History of allergic reaction to drugs similar to study medications
- Uncontrolled intercurrent illness
- Unable to swallow pills
- Not suitable candidate for surgery or radiation therapy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Stephenson Cancer Center at OU Health, University of Oklahoma Health Sciences Center (SCC-OUHSC)
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
Research Team
L
lead onco nurse, RN
CONTACT
K
Kelly Stratton, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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