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Androgen Receptor Inhibitor
Enzalutamide + Relacorilant for Prostate Cancer
Phase 1
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 3 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in steady-state (C-trough) enzalutamide caused by relacorilant
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Secondary outcome measures
Assess steady state enzalutamide drug levels when given with relacorilant
Assess steady state relacorilant drug levels when given with enzalutamide
Preliminary anti-cancer activity of relacorilant as measured by prostate specific antigen levels per response evaluation criteria in solid tumors
+2 moreTrial 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
~2760
Relacorilant
2021
Completed Phase 1
~140
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,004 Previous Clinical Trials
819,753 Total Patients Enrolled
20 Trials studying Prostate Cancer
8,259 Patients Enrolled for Prostate Cancer
Corcept TherapeuticsIndustry Sponsor
68 Previous Clinical Trials
6,356 Total Patients Enrolled
1 Trials studying Prostate Cancer
37 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,741 Total Patients Enrolled
560 Trials studying Prostate Cancer
507,071 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the maximum capacity of participants in this investigation?
"Yes, the information available from clinicaltrials.gov verifies that this medical trial is still recruiting participants. Initially posted on October 23rd 2018 and last updated on May 16th 2022, it aims to enrol 24 patients across a single site."
Answered by AI
Are individuals welcome to join this research initiative?
"Affirmative. Evident from the information hosted on clinicaltrials.gov, this medical trial remains open and is actively recruiting participants as of May 16th 2022; it was initially posted to the platform on October 23rd 2018. 24 individuals are needed for inclusion across a single study site."
Answered by AI
What evidence is there to support the utilization of Enzalutamide for therapeutic use?
"As this is still an early-stage trial, the safety of Enzalutamide has been assigned a score of 1 by our experts at Power due to limited data on its efficacy and security."
Answered by AI
Can you outline the other experiments conducted using Enzalutamide?
"Currently, 100 clinical trials are exploring the potential of Enzalutamide with 30 studies in Phase 3. Germantown, Tennessee is a hub for these experiments; however there are an astonishing 5767 sites worldwide where such research is taking place."
Answered by AI
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