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Antiandrogen

Group 1: Participants Who Receive Study Drug (Relacorilant) with Hormone Therapy and Enzalutamide for Prostate Cancer

Phase 2

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years and 9 months

Awards & highlights

Study Summary

"This trial aims to test if combining two drugs, relacorilant and enzalutamide, with hormone therapy is safe and effective for treating advanced prostate cancer. It is for patients for

Who is the study for?

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).Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include fatigue, hot flashes, decreased sex drive or other sexual dysfunction, joint pain or swelling, nausea, diarrhea or constipation. More serious risks could involve heart problems, seizures related to enzalutamide use.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years and 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years and 9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years and 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Response Rate of Subjects Receiving Relacorilant with Enzalutamide and Hormone Therapy

Secondary outcome measures

Radiographic Response Rate

• To determine the 3-year biochemical recurrence-free survival (bRFS) and metastasis-free survival (MFS) rate with combination hormonal therapy with Rela + ARSI with Enz compared to ARSI with Enz alone

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group 1: Participants Who Receive Study Drug (Relacorilant) with Hormone Therapy and EnzalutamideExperimental Treatment4 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 EnzalutamideExperimental Treatment4 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).

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

Radical Prostatectomy

2005

Completed Phase 2

~4550

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor

1,004 Previous Clinical Trials

819,687 Total Patients Enrolled

20 Trials studying Prostate Cancer

8,193 Patients Enrolled for Prostate Cancer

Russell Szmulewitz, MDPrincipal InvestigatorUniversity of Chicago

2 Previous Clinical Trials

74 Total Patients Enrolled

2 Trials studying Prostate Cancer

74 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients currently able to participate in this ongoing medical study?

"As per clinicaltrials.gov, this research endeavor is actively seeking volunteers. The trial was initially shared on October 9th, 2023, with the latest update being made on April 8th, 2024."

Answered by AI

What is the current number of participants being enrolled in this clinical research study?

"Indeed, the details on clinicaltrials.gov confirm that this trial is actively enrolling volunteers. The study was initially posted on October 9th, 2023 and most recently updated on April 8th, 2024. It aims to recruit a total of 90 participants at one designated location."

Answered by AI

Does the combination of Relacorilant and hormone therapy with Enzalutamide have approval from the FDA for Group 1 participants?

"The safety assessment for Group 1, which includes participants receiving Relacorilant along with hormone therapy and Enzalutamide, is rated at 2 by our team due to the ongoing Phase 2 trial. This indicates some existing safety data but a lack of efficacy evidence currently available."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Enzalutamide Plus the Glucocorticoid Receptor Antagonist Relacorilant Versus Placebo for Patients With High-risk Localized Prostate Cancer

2023. "A Study of Enzalutamide Plus the Glucocorticoid Receptor Antagonist Relacorilant Versus Placebo for Patients With High-risk Localized Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05726292.

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