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Antiandrogen
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
Awards & highlights
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
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
~2970
Relacorilant
2021
Completed Phase 3
~290
Radical Prostatectomy
2005
Completed Phase 2
~4550
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,034 Previous Clinical Trials
753,604 Total Patients Enrolled
21 Trials studying Prostate Cancer
8,261 Patients Enrolled for Prostate Cancer
Russell Szmulewitz, MDPrincipal InvestigatorUniversity of Chicago
2 Previous Clinical Trials
85 Total Patients Enrolled
2 Trials studying Prostate Cancer
85 Patients Enrolled for Prostate Cancer
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