Actively Recruiting
A Randomized Phase II Trial of Neoadjuvant Enzalutamide Plus the Glucocorticoid Receptor Antagonist Relacorilant Versus Placebo for Patients With High-risk Localized Prostate Cancer
Led by University of Chicago · Updated on 2026-03-04
90
Participants Needed
2
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and effectiveness of combining two drugs, relacorilant and enzalutamide, with hormone therapy (androgen deprivation therapy) in men with advanced, high-risk prostate cancer that has not responded to standard treatments. The goal is to see if this combination is safe and if it can improve surgery outcomes and delay cancer spread. This is a randomized, phase II trial sponsored by the University of Chicago. Participants receive either relacorilant plus enzalutamide with hormone therapy or a placebo plus enzalutamide with hormone therapy before surgery. All participants have androgen deprivation therapy injections every 1 to 3 months before undergoing a radical prostatectomy, which is surgery to remove the prostate and surrounding tissue. Surgery occurs up to 4 weeks after the pre-surgery treatments. The study compares these two groups to evaluate the added effect of relacorilant. During the approximately 3 years and 9 months of participation, participants will be monitored for response to treatment at 24 weeks and followed for up to nearly 4 years to check cancer recurrence and spread. Assessments include imaging scans, blood tests, and evaluations of biochemical and radiographic responses. Safety and effectiveness are carefully tracked throughout the study period.
CONDITIONS
Brief Title
A Study of Enzalutamide Plus the Glucocorticoid Receptor Antagonist Relacorilant Versus Placebo for Patients With High-risk Localized Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed prostate adenocarcinoma without small cell histology
- Localized disease with surgical resectability documented
- No distant metastatic disease on imaging; enlarged lymph nodes below iliac bifurcation allowed
- High or very high-risk disease as defined by clinical T3a or higher, Grade Group 4 or 5, or PSA greater than 20
- Eastern Cooperative Oncology Group performance status 0 or 1
- Total serum testosterone at least 100 ng/dL
- Normal liver function with bilirubin, AST/ALT, and albumin within specified limits
- Normal bone marrow function with platelet count, hemoglobin, and neutrophil count above thresholds
- Adequate kidney function with GFR of at least 30 mL/min
- Ability to understand and sign informed consent
- Patients with diabetes on glucose lowering medications able to self-monitor blood glucose
- Male patients and female partners of childbearing potential must use two acceptable birth control methods starting at screening and for 3 months after final drug administration
You will not qualify if you...
- Prior hormonal therapy for prostate cancer (except discontinued 5-alpha-reductase inhibitors)
- Inability to swallow capsules or gastrointestinal malabsorption
- History of other malignancies except certain treated cancers without disease for over 5 years
- Uncontrolled high blood pressure despite two or more medications
- History of seizure disorder or current use of anticonvulsants
- Serious uncontrolled infections or medical illnesses
- Active psychiatric illness or social situations limiting protocol compliance
- Symptomatic congestive heart failure (NYHA class II to IV)
- Concurrent use of strong CYP3A4 or CYP2C8 inhibitors or inducers
- Active medical conditions requiring systemic glucocorticoids for immunosuppression within last 6 months that are ongoing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 weeks
Participants receive hormone therapy with androgen deprivation therapy and either relacorilant plus enzalutamide or placebo plus enzalutamide before surgery.
Weekly visits for up to 4 weeks
Duration - 1 day
Participants undergo radical prostatectomy to remove the prostate and any surrounding tissue affected by cancer.
1 visit (in-person) for surgery
Duration - Up to 3 years and 9 months
Participants are monitored for safety and effectiveness after surgery, including long-term biochemical and metastasis-free survival assessments.
Periodic follow-up visits over 3 years and 9 months
Trial Site Locations
Total: 2 locations
1
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60453
Actively Recruiting
2
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
C
Cancer Trials
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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