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

{ "Study of Relacorilant and Enzalutamide for High-Risk Prostate Cancer", "This study is looking at whether combining two medications, relacorilant and enzalutamide (Xtandi), with hormone therapy (androgen deprivation therapy or ADT) can help men with high-risk localized prostate cancer. Researchers want to see if this combination is safe and effective at improving surgery results and delaying cancer spread. All participants will receive ADT before surgery to remove the prostate (radical prostatectomy). You might be eligible if you have prostate adenocarcinoma that has not spread to distant parts of the body and is considered high-risk. The main goal is to see how many people respond to the treatment after 24 weeks. The study plans to enroll 90 participants and will last about 3 years and 9 months.", "design": "This interventional study plans to enroll 90 male participants. It is testing relacorilant plus enzalutamide against a placebo.", "commitments": "You would receive androgen deprivation therapy (ADT) injections every 1-3 months before radical prostatectomy surgery. The total participation in this research will last about 3 years and 9 months.", "compensation": "Not stated in the trial record.", "follow_up": "The primary endpoint measures response rate at 24 weeks, but the overall study duration is about 3 years and 9 months.", }

Study design: Not specified.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting

PHASE2Ages 18+InterventionalTreatment

University of Chicago

~90 participants

Updated 2026-03-04 on ClinicalTrials.gov

What's tested:RelacorilantEnzalutamidePlacebo (Sugar Pill)Androgen Deprivation TherapyRadical Prostatectomy

At a glance

Recruiting sites

2 of 2 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Response Rate of Subjects Receiving Relacorilant with Enzalutamide and Hormone Therapy

Measured over 24 weeks

Conditions

Prostate Cancer

Prostate Adenocarcinoma

Where it's being run

2 sites across 2 states

Illinois1

Texas1

Study leadership

Russell Szmulewitz, MD · PRINCIPAL_INVESTIGATOR · University of Chicago

Who to contact

Cancer Trials

[email protected]

1-855-702-8222

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 3. 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 4. Eastern Cooperative Oncology Group performance status ≤ 1 (Appendix A) 5. Total serum testosterone 100 ng/dL 6. Patients must have normal hepatic function as defined below:

Total bilirubin \<1.5 X the upper limit of normal (note that in subjects with Gilbert's syndrome, if total bilirubin is \>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) \<2.5 X institutional upper limit of normal

Albumin 3.0 g/dL 7. Patients must have normal bone marrow function as defined below:

Platelet count (plt) 100,000 /L

Hemoglobin (Hgb) 10 g/dL

Absolute neutrophil count (ANC) 1500 8. Patients must have adequate renal function as defined below:

Condom (barrier method of contraception) AND

One of the following is required:

What this trial measures

Response Rate of Subjects Receiving Relacorilant with Enzalutamide and Hormone Therapy24 weeks
To determine if relacorilant (Rela) when added to androgen receptor signaling inhibition (ARSI) with enzalutamide (Enz) and androgen deprivation therapy (ADT) improves response rate compared to relacorilant with enzalutamide and ADT using both concurrent and historical controls. This outcome will be measured by assessing pathologic complete response rate (pCR) plus minimal residual disease (MRD) at radical prostatectomy (RP) after 24 weeks of neoadjuvant therapy.

Trialytics