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ZEN003694 + Enzalutamide for Prostate Cancer
Study Summary
This trial is testing a new drug, ZEN003694, to see if it is more effective than the current standard of care, enzalutamide, in patients with metastatic castration-resistant prostate cancer (mCRPC) who have progressed on prior abiraterone. Patients will be randomized to receive either ZEN003694 in combination with enzalutamide or enzalutamide monotherapy. The primary endpoint is radiographic progression-free survival (rPFS) by PCWG3 criteria.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 1 & 2 trial • 75 Patients • NCT02711956Trial Design
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Who is running the clinical trial?
Media Library
- I haven't had cancer treatment within the last 2 weeks or five half-lives before starting the study drug.I cannot or do not want to undergo chemotherapy.I have prostate cancer and did not respond well to abiraterone treatment.I have been treated with newer prostate cancer drugs but not with the older ones.I have been on hormone therapy for prostate cancer for at least 8 weeks, and my testosterone levels are low.I still have side effects from previous treatments, except for hair loss and nerve issues.I have not had radiation therapy in the last 2 weeks.I have had brain metastases, seizures, or conditions that could lead to seizures.My cancer has worsened despite being treated with abiraterone.I am a man aged 18 or older.My prostate cancer has spread and is not responding to hormone therapy.I have been given testosterone therapy after stopping abiraterone.I responded well to abiraterone for my prostate cancer and can care for myself.I've had chemotherapy for cancer that didn't respond to hormone therapy, but it was over 6 months ago.You have taken a drug that has not yet been approved by the FDA, including participation in a previous study involving ZEN003694.
- Group 1: Cohort A - ZEN003694 + Enzalutamide
- Group 2: Cohort A - Enzalutamide
- Group 3: Cohort B - ZEN003694 + Enzalutamide
- Group 4: Cohort B - Enzalutamide
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What verdict has the Food and Drug Administration reached regarding ZEN003694?
"Our team at Power assigned a score of 2 to ZEN003694 due to the lack of efficacy data, though there is some evidence confirming its safety."
Are there any precedents for using ZEN003694 in clinical trials?
"The first medical trial for ZEN003694 was initiated in 2005 at Rosemere Cancer Centre of Royal Preston Hospital. As of now, a total of 86 trials have been fully completed, with 98 more on-going studies occurring primarily in Lakewood, Colorado."
How many medical institutions are conducting this trial?
"The trial is currently operational in 8 centres, spanning Lakewood, New york and Asheville. It's important to pick the site closest to you so that travel obligations are minimized if participation is chosen."
What is the upper bound on participants for this clinical study?
"To move forward with the study, Zenith Epigenetics requires 200 qualified patients. The sponsor will be managing this trial from multiple locations such as Colorado Urology in Lakewood and Weill Cornell Medical College - New york Presbyterian Hospital in Manhattan."
Does this research endeavor accept additional participants?
"That is accurate. The information compiled on clinicaltrials.gov shows that this medical trial, which was first created on the 8th of September 2021, is currently enrolling participants. 200 test subjects will be accepted at a total of 8 different sites."
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