Enzalutamide + Relacorilant 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

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).

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Response Rate of Subjects Receiving Relacorilant with Enzalutamide and Hormone Therapy

Secondary study objectives

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

~3820

Relacorilant

2021

Completed Phase 3

~290