Enzalutamide + Relacorilant for Prostate Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Russell Szmulewitz, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of Chicago

Must be taking: Androgen deprivation therapy

Must not be taking: Anticonvulsants, Strong CYP3A4 inhibitors

Disqualifiers: Uncontrolled hypertension, Seizure disorder, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

Researchers conducting this study hope to learn about the safety and effectiveness of combining two study drugs, relacorilant and enzalutamide, plus androgen deprivation therapy (ADT), also known as hormone therapy. This study is for individuals who have been diagnosed with advanced, high-risk prostate cancer and standard therapies available to treat your disease have not been effective. Participation in this research will last about 3 years and 9 months.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on any hormonal therapy for prostate cancer or strong inhibitors or inducers of certain liver enzymes due to possible drug interactions. If you are on medications for benign prostate disease, they must be stopped before starting the study.

What data supports the effectiveness of the drug Enzalutamide + Relacorilant for prostate cancer?

Enzalutamide, a component of the treatment, is FDA-approved and has been shown to improve survival in patients with metastatic castration-resistant prostate cancer, suggesting its potential effectiveness in similar conditions.

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Is the combination of Enzalutamide and Relacorilant safe for humans?

Enzalutamide has been studied for safety in patients with prostate cancer, showing it is generally safe but can cause side effects like skin reactions. There is no specific safety data available for Relacorilant in this context.

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What makes the drug Enzalutamide + Relacorilant unique for prostate cancer?

Enzalutamide is a novel drug that blocks the androgen receptor, which is crucial for prostate cancer growth, and is used for castration-resistant prostate cancer. The combination with Relacorilant, which is not detailed in the provided research, suggests a unique approach potentially enhancing the effectiveness of Enzalutamide by targeting additional pathways.

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Eligibility Criteria

This trial is for individuals with advanced, high-risk prostate cancer that hasn't responded to standard treatments. Participants must have confirmed prostatic adenocarcinoma, be surgically resectable, no distant metastases (cancer spread), and an ECOG performance status ≤1 (meaning they are fully active or restricted in physically strenuous activity).

Inclusion Criteria

No evidence of distant metastatic disease on abdominopelvic imaging, bone imaging

Ability to understand and the willingness to sign a written informed consent document

My prostate cancer is confirmed and not small cell type.

Exclusion Criteria

Active psychiatric illness/social situations that would limit compliance with protocol requirements

My blood pressure is high despite taking more than two medications.

I have a history of seizures or I am currently taking seizure medication.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Therapy

Participants receive enzalutamide and relacorilant with hormone therapy for neoadjuvant treatment

24 weeks

Surgery

Participants undergo radical prostatectomy after neoadjuvant therapy

Up to 4 weeks post-treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years and 9 months

Participant Groups

The study tests combining relacorilant and enzalutamide with hormone therapy against a placebo plus hormone therapy in treating high-risk localized prostate cancer. The goal is to assess the safety and effectiveness of this combination over approximately 3 years and 9 months.

Group I: Group 1: Participants Who Receive Study Drug (Relacorilant) with Hormone Therapy and Enzalutamide Experimental Treatment 4 Interventions

All participants in this group will have surgery up to 4 weeks after receiving enzalutamide/relacorilant with hormone therapy. A radical prostatectomy (removal of the prostate and any surrounding tissue that the surgeon thinks may be affected by the cancer).

Group II: Group 1: Participants Who Receive Placebo (no study drug) with Hormone Therapy and Enzalutamide Experimental Treatment 4 Interventions

All participants in this group will have surgery up to 4 weeks after receiving enzalutamide/placebo (sugar pill in the form of 2 softgel capsules) with hormone therapy. A radical prostatectomy (removal of the prostate and any surrounding tissue that the surgeon thinks may be affected by the cancer).

Enzalutamide is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Xtandi for:

• Metastatic castration-resistant prostate cancer (mCRPC)
• Non-metastatic castration-resistant prostate cancer (nmCRPC)

🇪🇺 Approved in European Union as Xtandi for:

• Metastatic castration-resistant prostate cancer (mCRPC)
• Non-metastatic castration-resistant prostate cancer (nmCRPC)

🇨🇦 Approved in Canada as Xtandi for:

• Metastatic castration-resistant prostate cancer (mCRPC)
• Non-metastatic castration-resistant prostate cancer (nmCRPC)

🇯🇵 Approved in Japan as Xtandi for:

• Metastatic castration-resistant prostate cancer (mCRPC)
• Non-metastatic castration-resistant prostate cancer (nmCRPC)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Chicago Comprehensive Cancer Center Chicago, IL

University of Texas Southwestern Medical Center Dallas, TX

Who Is Running the Clinical Trial?

University of Chicago Lead Sponsor

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Health-related Quality of Life at the SPARTAN Final Analysis of Apalutamide for Nonmetastatic Castration-resistant Prostate Cancer Patients Receiving Androgen Deprivation Therapy. [2022] In SPARTAN, apalutamide improved metastasis-free and overall survival for patients with nonmetastatic castration-resistant prostate cancer (nmCRPC) with a prostate-specific antigen doubling time of ≤10 mo.

2. New Zealand pubmed.ncbi.nlm.nih.gov

Enzalutamide for patients with metastatic castration-resistant prostate cancer. [2020] To review and evaluate current literature on the US Food and Drug Administration (FDA)-approved drug enzalutamide (XTANDI(®)) in metastatic castration-resistant prostate cancer.

3. Poland pubmed.ncbi.nlm.nih.gov

Enzalutamide induced acute generalized exanthematous pustulosis. [2020] Label="INTRODUCTION" NlmCategory="BACKGROUND"> Enzalutamide (Xtandi®) is a new potent inhibitor of the signaling pathway for the androgen receptor with a half-life of 5.8 days. It has been on the market for the treatment of metastatic castration-resistant prostate cancer since November 2013.

4. United States pubmed.ncbi.nlm.nih.gov

Radium-223 in the Third-Line Setting in Metastatic Castration-Resistant Prostate Cancer: Impact of Concomitant Use of Enzalutamide on Overall Survival (OS) and Predictors of Improved OS. [2021] Radium-223 (Ra-223) has been recommended for bone-dominant metastatic castration-resistant prostate cancer (mCRPC). Second-generation hormone therapy in combination with Ra-223 in mCRPC has been utilized, yet its benefit has not been well elucidated. We investigated the potential survival benefit of concomitant enzalutamide with Ra-223 in the third-line setting and predictors of improved overall survival (OS).

5. Switzerland pubmed.ncbi.nlm.nih.gov

Enzalutamide as a Fourth- or Fifth-Line Treatment Option for Metastatic Castration-Resistant Prostate Cancer. [2021] To evaluate the efficacy of enzalutamide (Enz) as fourth- or fifth-line treatment in men with metastasized castration-resistant prostate cancer (mCRPC), by analyzing a retrospective cohort of heavily pretreated patients.

6. United States pubmed.ncbi.nlm.nih.gov

Safety of enzalutamide in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel: expanded access in North America. [2021] The open-label, single-arm enzalutamide expanded access program (EAP) in the United States and Canada evaluated the safety of enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) who had previously received docetaxel.

7. United States pubmed.ncbi.nlm.nih.gov

Enzalutamide, an androgen receptor signaling inhibitor, induces tumor regression in a mouse model of castration-resistant prostate cancer. [2022] Enzalutamide (formerly MDV3100 and available commercially as Xtandi), a novel androgen receptor (AR) signaling inhibitor, blocks the growth of castration-resistant prostate cancer (CRPC) in cellular model systems and was shown in a clinical study to increase survival in patients with metastatic CRPC. Enzalutamide inhibits multiple steps of AR signaling: binding of androgens to AR, AR nuclear translocation, and association of AR with DNA. Here, we investigate the effects of enzalutamide on AR signaling, AR-dependent gene expression and cell apoptosis.

8. Germany pubmed.ncbi.nlm.nih.gov

Managing lines of therapy in castration-resistant prostate cancer: real-life snapshot from a multicenter cohort. [2021] To provide a snapshot of toxicities and oncologic outcomes of Abiraterone (AA) and Enzalutamide (EZ) in a chemo-naïve metastatic castration-resistant prostate cancer (mCPRC) population from a longitudinal real-life multicenter cohort.

9. New Zealand pubmed.ncbi.nlm.nih.gov

Enzalutamide: A Review in Castration-Resistant Prostate Cancer. [2021] Oral enzalutamide (Xtandi®), a second generation androgen receptor inhibitor, is indicated for the treatment of castration-resistant prostate cancer (CRPC) in numerous countries worldwide, with specific indications in this patient population varying between individual countries. Based on extensive experience in the clinical trial and/or real-world settings, oral enzalutamide 160 mg once daily is an effective and generally well tolerated treatment in a broad spectrum of patients with CRPC, including in nonmetastatic and metastatic disease and in chemotherapy-naive and -experienced metastatic CRPC. Enzalutamide is an emerging option for the treatment of men with nonmetastatic CRPC who are at high-risk for developing metastatic disease, and remains an important first-line option in chemotherapy-naive or -experienced patients with metastatic CRPC.

10. United States pubmed.ncbi.nlm.nih.gov

Enzalutamide: a novel antiandrogen for patients with castrate-resistant prostate cancer. [2021] Enzalutamide (MDV3100, Xtandi, MedivationAstellas) is an oral inhibitor of androgen receptor signaling that blocks androgen receptor interaction, inhibits translocation of the androgen receptor to the nucleus, impairs androgen receptor binding to DNA, and inhibits coactivator recruitment and receptor-mediated DNA transcription. In a phase III randomized study comparing enzalutamide with placebo in men with progressive castration-resistant prostate cancer (CRPC) who were previously treated with docetaxel, enzalutamide showed an improvement in overall survival (18.4 vs. 13.6 months, HR, 0.63; P