OncoMatch/Clinical Trials/NCT06130995
Relugolix + Enzalutamide Study in High-Risk Prostate Cancer
Is NCT06130995 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Relugolix and Enzalutamide for androgen deprivation therapy.
Treatment: Relugolix and Enzalutamide — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Required: Stage III
Excluded: Stage DISTANT METASTATIC
Grade: ISUP grade 4ISUP grade 5Gleason score >7 (ISUP, Gleason)
Locally advanced high-risk prostate defined as i. PSA >20 ng/mL or ISUP grade 4/5 (Gleason score >7) or cT2c or ii. Any PSA, any ISUP grade, cT3-4 or cN+ (locally advanced)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Lab requirements
Blood counts
Platelets ≥100 × 10^3/μL; Hemoglobin ≥ 10.0 g/dL; Leukocytes (WBC) ≥ 3 × 10^3/μL; Absolute neutrophil count ≥1.5 × 10^3/μL
Kidney function
Serum creatinine ≤ 1.5 × ULN; OR Measured or calculated creatinine clearance ≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN
Liver function
Serum AST and ALT ≤2.5 × upper limit of normal (ULN); Total bilirubin ≤1.5 ×ULN (unless values are consistent with Gilbert's syndrome for which the total bilirubin must be < 3x ULN)
Have normal organ and bone marrow function measured at the screening visit including Platelets ≥100 × 10^3/μL; Hemoglobin ≥ 10.0 g/dL; Leukocytes (WBC) ≥ 3 × 10^3/μL; Absolute neutrophil count ≥1.5 × 10^3/μL; Serum AST and ALT ≤2.5 × ULN; Total bilirubin ≤1.5 ×ULN (unless values are consistent with Gilbert's syndrome for which the total bilirubin must be < 3x ULN); Serum creatinine ≤ 1.5 × ULN; OR Measured or calculated creatinine clearance ≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Stephenson Cancer Center at OU Health, University of Oklahoma Health Sciences Center (SCC-OUHSC) · Oklahoma City, Oklahoma
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