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Prostate CancerPhase 1NCT03674814

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

A Phase 1 study testing Enzalutamide and Relacorilant in people with Prostate Cancer, run by University of Chicago at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Enzalutamide and Relacorilant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteUnited States
Study dates
23 Oct 2018to 10 Jun 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed prostate cancer with documented metastatic disease
  • Evidence of castrate testosterone level <50ng/dl (or surgical castration)
  • 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.
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  • 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.
  • Any prior therapy for castrate disease is acceptable except prior GR antagonist treatment (e.g. mifepristone or relacorilant).
  • Any other radiotherapy or radionuclide require 28-day washout prior to first dose of study drug.
  • Denosumab or zoledronic acid are allowed.
  • ECOG performance status ≤ 2.
  • Patients must have normal hepatic function as defined below:
  • Total bilirubin </=1.5 x the upper limit of normal
  • 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) >/= 80,000 /microliter
  • Hemoglobin (Hgb) >/= 9 g/dL
  • Absolute neutrophil count (ANC) >/= 1500
  • Patients must have normal renal function as defined below:
  • 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, or 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.

Who cannot join

  • 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.
  • Inability to swallow capsules or known gastrointestinal malabsorption.
  • Evidence of visceral disease on imaging in a patient who is an appropriate candidate for cytotoxic chemotherapy (docetaxel or cabazitaxel).
  • 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.
  • 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).
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  • History of seizure disorder or active use of anticonvulsants. Medications used to treat neuropathic pain such as gabapentin or pregabalin are allowed.
  • Documented history of or current brain metastases due to seizure risk
  • Serious intercurrent infections or non-malignant medical illnesses that are uncontrolled.
  • Active psychiatric illness/social situations that would limit compliance with protocol requirements.
  • NYHA class II, NYHA class III, or IV congestive heart failure (any symptomatic heart failure).
  • Concurrent therapy with strong inhibitors or inducers of CYP3A4 or CYP2C8 (See Section 9.12below for list of strong inhibitor or inducers) 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University Of Chicago Medicine Comprehensive Cancer Center

    Chicago, Illinois, 60637

Other trials in United States

About this study

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

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).

Read the 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).

Conditions
Prostate Cancer
Being tested
Enzalutamide, Relacorilant
Keywords
prostate cancer, Enzalutamide, Relacorilant
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EnzalutamideDrug

    Also called Xtandi(R)

    Enzalutamide will be taken by mouth at assigned dose. Enzalutamide will be obtained as standard of care prescription (not provided by study).

  • RelacorilantDrug

    Also called CORT-125134

    Relacorilant will be taken by mouth at assigned dose. Relacorilant will be provided by the study.

Study groups in NCT03674814
Study groupRoleWhat they receive
Dose LevelExperimentalRelacorilant will be given at a dose once daily. Enzalutamide will be given at a dose once daily.
Receives: Drug: Enzalutamide; Drug: Relacorilant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

    Measured: 28 days after start of dosing

  2. Change in steady-state (C-trough) enzalutamide caused by relacorilant

    Measured: 28 days after start of dosing

Secondary outcomes (5)

  1. Preliminary anti-cancer activity of relacorilant as measured by prostate specific antigen levels per response evaluation criteria in solid tumors

    Measured: 12 weeks after initial start of combination dosing

  2. Preliminary anti-cancer activity of relacorilant as measured by tumor response per response evaluation criteria in solid tumors

    Measured: 12 weeks after initial start of combination dosing

  3. Assess steady state relacorilant drug levels when given with enzalutamide

    Measured: 28 days after start of dosing

  4. Assess steady state enzalutamide drug levels when given with relacorilant

    Measured: 28 days after start of dosing

  5. Radiographic progression free survival (PFS) of the combination

    Measured: Approximately 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2018
  2. Study start23 Oct 2018
  3. Primary completion10 Jun 2024
  4. Study completion10 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Patients will be sequentially enrolled to increasing dose escalation cohorts based on safety and PK.
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03674814
Sponsor's protocol ID
IRB18-0152
Other IDs
P50CA180995
Status last verified
Mar 2026
First submitted
29 Aug 2018
Last updated
31 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Serritella AV, Shevrin D, Heath EI, Wade JL, Martinez E, Anderson A, Schonhoft J, Chu YL, Karrison T, Stadler WM, Szmulewitz RZ. Phase I/II Trial of Enzalutamide and Mifepristone, a Glucocorticoid Receptor Antagonist, for Metastatic Castration-Resistant Prostate Cancer. Clin Cancer Res. 2022 Apr 14;28(8):1549-1559. doi: 10.1158/1078-0432.CCR-21-4049.

    PubMed 35110415

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Enzalutamide and Relacorilant in people with Prostate Cancer, run by University of Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 31 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 (time frame: 28 days after start of dosing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03674814, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.

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