Actively Recruiting

Phase 2
Age: 18Years +
MALE
NCT05726292

A Study of 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

168 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers conducting this study hope to learn about the safety and effectiveness of combining two study drugs, relacorilant and enzalutamide, plus androgen deprivation therapy (ADT), also known as hormone therapy. This study is for individuals who have been diagnosed with advanced, high-risk prostate cancer and standard therapies available to treat your disease have not been effective. Participation in this research will last about 3 years and 9 months.

CONDITIONS

Official Title

A Study of Enzalutamide Plus the Glucocorticoid Receptor Antagonist Relacorilant Versus Placebo for Patients With High-risk Localized Prostate Cancer

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically or cytologically confirmed prostatic adenocarcinoma without primary small cell histology
  • Localized disease with documented surgical resectability
  • No distant metastatic disease on abdominopelvic and bone imaging (enlarged lymph nodes below iliac bifurcation allowed)
  • High or very high-risk disease defined by clinical T3a or higher, Grade Group 4 or 5, or PSA >20
  • Eastern Cooperative Oncology Group performance status 0 or 1
  • Total serum testosterone 100 ng/dL
  • Normal liver function: total bilirubin <1.5x upper limit of normal, AST/ALT <2.5x upper limit, albumin ≥3.0 g/dL
  • Normal bone marrow function: platelet count ≥100,000/L, hemoglobin ≥10 g/dL, absolute neutrophil count ≥1500
  • Adequate kidney function with glomerular filtration rate ≥30 mL/min
  • Ability to understand and sign informed consent
  • Patients with diabetes on glucose-lowering medication who can self-monitor blood glucose daily
  • Male patients and female partners of childbearing potential must use two acceptable birth control methods (one must be a condom) during the study and for 3 months after
Not Eligible

You will not qualify if you...

  • Prior hormonal therapy for prostate cancer (except discontinued 5-alpha-reductase inhibitors)
  • Inability to swallow capsules or known gastrointestinal malabsorption
  • History of other cancers except certain treated skin, bladder, or early-stage cancers without disease for over 5 years
  • Uncontrolled high blood pressure despite more than 2 oral medications
  • History of seizures or current use of anticonvulsants (except certain pain medications)
  • Serious uncontrolled infections or medical illnesses
  • Active psychiatric illness or social situations limiting study compliance
  • Symptomatic congestive heart failure (NYHA class II, III, or IV)
  • Concurrent use of strong CYP3A4 or CYP2C8 inhibitors or inducers
  • Active medical conditions requiring systemic glucocorticoids for immunosuppression in the last 6 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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

Loading map...

Research Team

C

Cancer Trials

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here