Study Summary
This trial is testing a new combination drug to see if it is safe and effective in treating prostate cancer that has spread.
- Prostate Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
5 Primary · 0 Secondary · Reporting Duration: Baseline to End of Cycle 1 (each cycle is 28 days)
Trial Safety
Safety Progress
Trial Design
7 Treatment Groups
Phase 2 Enzalutamide single agent
1 of 7
Phase 1 Dose Expansion
1 of 7
Phase 2 Enzalutamide + EPI-7386 (Randomized 2:1)
1 of 7
Phase 1 Cohort 2
1 of 7
Phase 1 Cohort 1
1 of 7
Phase 1 Cohort 4
1 of 7
Phase 1 Cohort 3
1 of 7
Active Control
Experimental Treatment
150 Total Participants · 7 Treatment Groups
Primary Treatment: EPI-7386 with Enzalutamide · No Placebo Group · Phase 1 & 2
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · Male Participants · 11 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
Are participants being enrolled in this experiment right now?
"That is correct. The clinicaltrials.gov website lists this trial as "recruiting." It was originally posted on December 21st, 2021 and updated June 30th, 2022. They are looking for 150 people to participate at 7 different locations." - Anonymous Online Contributor
What is the total number of research facilities conducting this experiment?
"Presently, there are 7 sites that are enrolling patients for this clinical trial with additional locations in Buffalo, Madison and Port Saint Lucie. If you elect to participate in this study, please choose the site closest to your residence to minimize travel." - Anonymous Online Contributor
How many people are total are included in this experiment?
"The sponsor, ESSA Pharmaceuticals, needs to recruit 150 participants that meet the eligibility requirements in order to commence this study. The trial will be conducted at various sites - two locations being Roswell Park Comprehensive Cancer Center (Buffalo, New York) and University of Wisconsin (Madison, Wisconsin)." - Anonymous Online Contributor
Are there any other similar medical studies that have used EPI-7386 in combination with Enzalutamide?
"103 different clinical trials are being conducted for EPI-7386 with Enzalutamide. 30 of those currently active studies are in Phase 3. Most research concerning EPI-7386 is based out of Germantown, Tennessee; however, 5748 locations worldwide are running these types of trials." - Anonymous Online Contributor