Study on Enzalutamide and Relacorilant for High-Risk Localized Prostate Cancer
Sponsor: University of Chicago
ClinicalTrials ID:NCT05726292
This clinical trial is testing the safety and effectiveness of combining two study drugs, relacorilant and enzalutamide, with hormone therapy for patients with high-risk localized prostate cancer. The study is for those whose cancer has not responded to standard treatments and will last about 3 years and 9 months.
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Program Overview
The study aims to find out if combining two study drugs, relacorilant and enzalutamide, with hormone therapy is safe and can improve surgery outcomes and delay the spread of prostate cancer in patients with high-risk localized prostate cancer. Prostate cancer cells often need hormones like testosterone to grow. Hormone therapy, also known as androgen deprivation therapy, works by reducing these hormones to stop cancer growth. Enzalutamide is a medication that blocks these hormones and is commonly used when prostate cancer spreads.
Description
The purpose of this study is to evaluate the safety and effectiveness of combining two study drugs, relacorilant and enzalutamide, with hormone therapy in patients with high-risk localized prostate cancer. Researchers want to see if this combination can improve surgery results and delay the spread of cancer. Prostate cancer cells usually need hormones like testosterone to grow. Hormone therapy reduces these hormones to stop cancer growth. Enzalutamide is a hormone-blocking medication used when prostate cancer spreads. This study will involve patients who plan to have a radical prostatectomy, which is the surgical removal of the prostate and surrounding tissue.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with prostate cancer without small cell histology.
- Cancer is localized and can be surgically removed.
- No evidence of cancer spread to distant areas, but enlarged lymph nodes below the iliac bifurcation are allowed.
- High or very high-risk disease, such as clinical stage T3a or higher, high-grade cancer, or PSA level over 20.
- Good overall health with a performance status of 0 or 1.
- Normal liver and kidney function based on specific blood tests.
- Normal bone marrow function with adequate blood cell counts.
- Ability to understand and sign a consent form.
- Patients with diabetes must agree to monitor blood sugar levels.
- Male patients and their female partners must use two forms of birth control during the study and for three months after.
Exclusion Criteria
- Previous hormone therapy for prostate cancer, except for certain medications for benign prostate disease.
- Difficulty swallowing capsules or known digestive issues.
- History of other cancers, except for certain non-threatening types.
- Uncontrolled high blood pressure despite medication.
- History of seizures or current use of seizure medications, except for certain pain medications.
- Serious infections or uncontrolled medical conditions.
- Psychiatric or social issues that affect study participation.
- Heart failure with symptoms.
- Use of certain medications that interact with study drugs.
- Medical conditions requiring recent use of systemic glucocorticoids.
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