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Study of Drug 1 (Enzalutamide) Plus Drug 2 (Relacorilant) for Patients With Prostate Cancer | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1

Study of Drug 1 (Enzalutamide) Plus Drug 2 (Relacorilant) for Patients With Prostate Cancer

A Phase I Trial of Enzalutamide Plus the Glucocorticoid Receptor Antagonist CORT-125134 (Relacorilant) for Patients With Metastatic Castration Resistant Prostate Cancer (CRPC)

NCT03674814•University of Chicago

View on ClinicalTrials.gov

Summary

The study is an open-label Phase 1 study of the combination of relacorilant with enzalutamide in patients with metastatic castration resistant prostate cancer (mCRPC).

Detailed Description

The study is an open-label Phase 1 study of the combination of relacorilant with enzalutamide in patients with metastatic castration resistant prostate cancer (mCRPC). Patients will be enrolled in 6 patient cohorts with a 6+3 design and a 28 day DLT period. Doses of relacorilant, enzalutamide will be adjusted based on safety and pharmacokinetics (PK). Once a safe dose with appropriate drug levels (PK) has been established, the cohort will be expanded to a total of 12 patients to refine safety and PK at the recommended phase II dose (RP2D).

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. Histologically or cytologically confirmed prostate cancer with documented metastatic disease
•2. Evidence of castrate testosterone level \<50ng/dl (or surgical castration)
•3. Evidence of disease progression:
•* 2 or more new lesions on bone scan or
•* Progressive disease on CT/MRI according to Response Evaluation Criteria in Solid Tumors 1.1 criteria or
•* Rising Prostate Specific Antigen (PSA): PSA evidence for progressive prostate cancer consists of a minimum PSA level of at least 2 ng/ml, which has subsequently risen on at least 2 successive occasions, at least 2 weeks apart.
•4. Prior treatment with at least one line of potent androgen receptor signaling inhibitor (e.g. abiraterone, enzalutamide, apalutamide) in either castration-sensitive or castration-resistant setting.
•5. Any prior therapy for castrate disease is acceptable except prior GR antagonist treatment (e.g. mifepristone or relacorilant).
•6. Any other radiotherapy or radionuclide require 28-day washout prior to first dose of study drug.
•7. Denosumab or zoledronic acid are allowed.
+21 more criteria

Exclusion Criteria

•1. Therapy with other hormonal therapy, including any dose of megestrol acetate (Megace), finasteride (Proscar), dutasteride (Avodart), or any herbal product known to decrease PSA levels (e.g., saw palmetto and PC-SPES), or any systemic corticosteroid within 2 weeks prior to first dose of study drug.
•a.Patients who have been on systemic corticosteroids with prednisone equivalent of 10mg or greater for greater than 3 months immediately prior to participation in this study must have documented ability to tolerate cessation of corticosteroids prior to enrollment.
•2. Inability to swallow capsules or known gastrointestinal malabsorption.
•3. Evidence of visceral disease on imaging in a patient who is an appropriate candidate for cytotoxic chemotherapy (docetaxel or cabazitaxel).
•4. History of other malignancies, with the exception of: adequately treated non-melanoma skin cancer, adequately treated superficial bladder cancer, stage 1 or 2 malignancies who are without evidence of disease, or other cancers curatively treated with no evidence of disease for \> 5 years from enrollment.
•5. 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).
•6. History of seizure disorder or active use of anticonvulsants. Medications used to treat neuropathic pain such as gabapentin or pregabalin are allowed.
•7. Documented history of or current brain metastases due to seizure risk
•8. Serious intercurrent infections or non-malignant medical illnesses that are uncontrolled.
•9. Active psychiatric illness/social situations that would limit compliance with protocol requirements.
+3 more criteria

Locations (1)

University Of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, United States

Key Dates

Start Date

October 23, 2018

Primary Completion Date

January 10, 2027

Completion Date

March 10, 2027

Last Updated

March 4, 2026

Enrollment

ACTUAL participants

Conditions

Prostate Cancer

Interventions

Enzalutamide

DRUG

Relacorilant

DRUG

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT06842498

Metastatic Castration-Resistant Prostate Cancer

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RECRUITINGPHASE2

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

NCT05691465

Metastatic Prostate Adenocarcinoma With Neuroendocrine DifferentiationMetastatic Prostate Neuroendocrine Carcinoma+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 4, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of Drug 1 (Enzalutamide) Plus Drug 2 (Relacorilant) for Patients With Prostate Cancer

Inclusion Criteria

Exclusion Criteria

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC