NCT05726292RecruitingPhase 2

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

A Randomized Phase II Trial of Neoadjuvant Enzalutamide Plus the Glucocorticoid Receptor Antagonist Relacorilant Versus Placebo for Patients With High-risk Localized Prostate Cancer

Source: ClinicalTrials.gov · Last updated 31 Aug 2026

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Phase (registry): Phase 2
Study type: Interventional
Enrollment: 90 (estimated)
First submitted: 2 Feb 2023
Start date: 6 Jan 2025
Primary completion date: 1 Oct 2027
Lead sponsor: University of Chicago
Diseases: Prostate cancer
NCT number: NCT05726292

What you commit to

Study type: Interventional · Phase 2
Planned participants: 90
From 6 Jan 2025 to the primary completion date, 1 Oct 2027
4 sites in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

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 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
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
Patients must have adequate renal function as defined below:
- glomerular filtration rate (GFR) 30 mL/min
Ability to understand and the willingness to sign a written informed consent document.
Patients with active diabetes mellitus on glucose lowering medications are eligible provided they agree to and are able to self-monitor daily blood glucose levels due to potential risk of lowering glucose levels on relacorilant.
Male patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 3 months after final study drug administration. Two acceptable methods of birth control thus include the following:
- Condom (barrier method of contraception) AND
- One of the following is required:
- Established use of oral, injected or implanted hormonal method of contraception by the female partner;
- Placement of an intrauterine device (IUD) or intrauterine system (IUS) by the female partner;
- Additional barrier method: Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository by the female partner;
- Tubal ligation in the female partner;
- Vasectomy or other procedure resulting in infertility (e.g., bilateral orchiectomy), for more than 6 months.
- 3.2 Exclusion Criteria
Therapy with ANY hormonal therapy for prostate cancer (prior 5-alpha-reductase inhibitors for benign prostate disease is allowed but must be discontinued prior to study initiation).
Inability to swallow capsules or known gastrointestinal malabsorption.
History of other malignancies, with the exception of: adequately treated non-melanoma skin cancer, adequately treated superficial bladder cancer, stage 1 or 2 malignancies that are without evidence of disease, or other cancers curatively treated with no evidence of disease for \> 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.

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Save your city in your profile to sort them by distance.

Site	City	Country	Site status
University of Chicago Comprehensive Cancer Center Coordinator of this site? Confirm its status	Chicago	United States	Recruiting
University of Texas Southwestern Medical Center Coordinator of this site? Confirm its status	Dallas	United States	Recruiting
Endeavor Health Coordinator of this site? Confirm its status	Evanston	United States	Not yet recruiting
Oregon Health Science University Coordinator of this site? Confirm its status	Portland	United States	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.