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Androgen Receptor Inhibitor
Enzalutamide + Relacorilant for Prostate Cancer
Phase 1
Waitlist Available
Led By Russell Szmulewitz, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically or cytologically confirmed prostate cancer with documented metastatic disease
ECOG performance status ≤ 2
Must not have
Evidence of visceral disease on imaging in a patient who is an appropriate candidate for cytotoxic chemotherapy (docetaxel or cabazitaxel)
NYHA class II, NYHA class III, or IV congestive heart failure (any symptomatic heart failure)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new combination treatment for mCRPC.
Who is the study for?
Men with advanced prostate cancer that has resisted castration and shown progression despite previous treatments, but not including prior GR antagonist therapy. Participants must have stable vital functions, no history of seizures or certain other medical conditions, and agree to use two forms of birth control if applicable.
What is being tested?
The trial is testing a combination of Enzalutamide and Relacorilant in men with metastatic castration-resistant prostate cancer (mCRPC). It's an early-phase study where both drugs are given openly to see how well they work together.
What are the potential side effects?
Possible side effects include fatigue, digestive issues, potential blood pressure changes, risk of lowering glucose levels for diabetic patients on medication, and the usual risks associated with hormone therapies such as hot flashes or sexual dysfunction.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer has spread and this was confirmed through testing.
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I can take care of myself but might not be able to do heavy physical work.
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My testosterone levels are very low or I've had surgery to lower them.
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I have been treated with medications like abiraterone for prostate cancer.
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My liver functions are within normal ranges.
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My kidney function is normal, with a GFR of 30 mL/min or higher.
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My cancer has worsened, shown by new bone lesions, CT/MRI results, or rising PSA levels.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My scans show internal organ cancer, and I can undergo strong chemotherapy.
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I have symptoms of heart failure.
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I have a condition that needed steroids for treatment in the last 6 months.
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I do not have serious infections or health issues that are not under control.
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I am not taking medication that strongly affects drug processing in my body.
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My blood pressure is high despite taking more than 2 medications.
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I cannot swallow pills or have a condition that affects how my body absorbs food.
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I have or had brain metastases.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Dose LevelExperimental Treatment2 Interventions
Relacorilant will be given at a dose once daily. Enzalutamide will be given at a dose once daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enzalutamide
2014
Completed Phase 4
~3820
Relacorilant
2021
Completed Phase 3
~290
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,055 Previous Clinical Trials
760,674 Total Patients Enrolled
22 Trials studying Prostate Cancer
8,362 Patients Enrolled for Prostate Cancer
Corcept TherapeuticsIndustry Sponsor
70 Previous Clinical Trials
6,508 Total Patients Enrolled
1 Trials studying Prostate Cancer
37 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,925 Previous Clinical Trials
41,017,966 Total Patients Enrolled
515 Trials studying Prostate Cancer
332,925 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been able to stop taking steroids after using them for more than 3 months.My scans show internal organ cancer, and I can undergo strong chemotherapy.My prostate cancer has spread and this was confirmed through testing.I haven't taken hormonal therapies or steroids that affect PSA levels in the last 2 weeks.I have symptoms of heart failure.I have a condition that needed steroids for treatment in the last 6 months.My testosterone levels are very low or I've had surgery to lower them.I have been treated with medications like abiraterone for prostate cancer.I have not had any radiotherapy or radionuclide treatments in the last 28 days.I am taking Denosumab or Zoledronic acid.My liver functions are within normal ranges.I have had cancer before, but it was either skin cancer, superficial bladder cancer, early-stage cancer treated over 5 years ago, or any cancer cured without signs of disease for more than 5 years.I have a history of seizures or I'm currently using seizure medications, except for gabapentin or pregabalin.I do not have serious infections or health issues that are not under control.My partner and I are using two effective birth control methods, one being a condom.I have had treatments for castrate disease but not with GR antagonists like mifepristone.I can take care of myself but might not be able to do heavy physical work.I am not taking medication that strongly affects drug processing in my body.My blood pressure is high despite taking more than 2 medications.My kidney function is normal, with a GFR of 30 mL/min or higher.My cancer has worsened, shown by new bone lesions, CT/MRI results, or rising PSA levels.I have diabetes, take medication for it, and can monitor my blood sugar daily.I cannot swallow pills or have a condition that affects how my body absorbs food.I have or had brain metastases.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Level
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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