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

About This Trial

This study is testing whether adding an experimental medicine called relacorilant to standard hormone therapy is safe and effective for treating prostate cancer.
It is for men with high-risk prostate cancer that can be removed with surgery and has not spread to distant parts of the body.
To qualify, you must not have previously received hormone therapy for your prostate cancer.
Before deciding to join, you should know that you might receive an inactive dummy pill (placebo) instead of the experimental medicine, and taking part will last for nearly four years.

More Information

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.

Who Can Enroll

Age Range: 18 years and older
Gender: Male
Who This Trial is For: This study is testing whether adding an experimental medicine called relacorilant to standard hormone therapy is safe and effective for treating prostate cancer.

Study Details

Start Date: January 6, 2025
Lead Sponsor: University of Chicago

Full Eligibility Criteria

Inclusion Criteria

Histologically or cytologically confirmed prostatic adenocarcinoma without primary small cell histology
Localized disease:
- Surgical resectability must be documented prior to enrollment
- No evidence of distant metastatic disease on abdominopelvic imaging, bone imaging
  - Enlarged lymph nodes below the iliac bifurcation (clinical stage N1) is allowed
  - Either cross-sectional abdominopelvic imaging + technetium bone scan or PSMA PET imaging will be acceptable to rule out distant metastatic disease
High or very high-risk disease (https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf) as defined by having one or more of the following:
- Clinical T3a or higher
- Histologic Grade Group 4 or 5
- PSA >20
Eastern Cooperative Oncology Group performance status ≤ 1 (Appendix A)
Total serum testosterone 100 ng/dL
Patients must have normal hepatic function as defined below:
- Total bilirubin 1.5 X ULN, measure direct and indirect bilirubin. If direct bilirubin is ≤1.5 X ULN, the subject may be eligible)
- AST(SGOT)/ALT(SGPT) 5 years from enrollment.
Blood pressure that is not controlled despite > 2 oral agents (SBP >160 and DBP >90 documented during the screening period with no subsequent blood pressure readings >160/100).
History of seizure disorder or active use of anticonvulsants. Medications used to treat neuropathic pain such as gabapentin or pregabalin are allowed.
Serious inter-current infections or non-malignant medical illnesses that are uncontrolled.
Active psychiatric illness/social situations that would limit compliance with protocol requirements.
New York Heart Association (NYHA) class II, class III, or IV congestive heart failure (any symptomatic heart failure).
Concurrent therapy with strong inhibitors of Cytochrome P450 3A4 or CYP2C8 due to concerning possible drug-drug interactions.
Concurrent therapy with strong inducers of Cytochrome P450 3A4 due to concerning possible drug-drug interactions.
Presence of concurrent medical conditions requiring systemic glucocorticoids for immunosuppression (e.g. autoimmune diseases, organ transplantation) that is active and has required glucocorticoids in the last 6 months.