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EPI-7386 + Enzalutamide for Prostate Cancer

Phase 2
Waitlist Available
Led By Christopher Wee, MD
Research Sponsored by Pedro Barata, MD, MSc
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 baseline, 2 weeks, 11 weeks, and 20 weeks after beginning treatment
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to see how well EPI-7386 works with Enzalutamide in patients with prostate cancer. They want to see if this combination can shrink the tumors and how the body

Who is the study for?
This trial is for individuals with newly diagnosed metastatic hormone-sensitive prostate cancer. Participants will take EPI-7386 and Enzalutamide orally, alongside standard Androgen Deprivation Therapy. They must be able to attend clinic visits every two weeks.
What is being tested?
The study tests the effectiveness of a new drug combination: EPI-7386 with Enzalutamide, in addition to standard Androgen Deprivation Therapy, against prostate cancer. It aims to assess tumor response and understand how the body processes these drugs.
What are the potential side effects?
Possible side effects include fatigue, hot flashes, reduced sexual desire or activity, nausea, diarrhea or constipation, joint or muscle pain, swelling in arms or legs due to fluid retention.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 2 weeks, 11 weeks, and 20 weeks after beginning treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2 weeks, 11 weeks, and 20 weeks after beginning treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Biochemical response rate
ORR (confirmed)
PSA progesterone-free survival (PFS)
+1 more
Secondary study objectives
AUC0-24
Changes in Eastern Cooperative Oncology Group (ECOG) performance status
Clearance after extravascular administration
+9 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: EPI-7386 + EnzalutamideExperimental Treatment3 Interventions
EPI-7386 at 600 mg twice daily orally with standard of care Enzalutamide at 160 mg, once daily, orally for 36 months of treatment (11 cycles).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Androgen Deprivation Therapy (ADT)
2005
Completed Phase 3
~610
Enzalutamide
2014
Completed Phase 4
~3820

Find a Location

Who is running the clinical trial?

Pedro Barata, MD, MScLead Sponsor
ESSA Pharma Inc.UNKNOWN
Christopher Wee, MDPrincipal InvestigatorCleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
~9 spots leftby Mar 2026
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