Phase 2 Prostate Cancer Trial, Recruiting NCT04986423 Sponsor: Zenith Epigenetics Condition: Prostate Cancer
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Phase 2 Prostate Cancer Trial, Recruiting

NCT04986423
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are male and aged 18 or older
  • People who have prostate cancer that has spread to other parts of the body (metastatic), is no longer responding to hormone-lowering treatment (castration-resistant), and has been confirmed by a tissue sample (biopsy)
  • People who have had their testosterone surgically or medically reduced for at least 8 weeks before screening, with a blood test confirming very low testosterone levels (below 50 ng/dL) within 4 weeks of starting the study drug
  • People whose prostate cancer continued to grow or spread while on a treatment called abiraterone, based on specific medical guidelines (PCWG3 criteria)
  • People who, in the treating doctor's opinion, are not suitable for chemotherapy, or who have chosen not to have chemotherapy
  • Cohort A only — People who responded poorly to abiraterone, meaning either: abiraterone was started when the cancer was still hormone-sensitive and lasted less than 12 months, or did not bring a key cancer marker (PSA) down to a very low level; OR abiraterone was started when the cancer was already castration-resistant and lasted less than 6 months, or did not reduce PSA by at least 50%
  • Cohort B only — People who responded well to abiraterone, meaning either: abiraterone was started when the cancer was still hormone-sensitive and lasted 12 months or longer, and brought PSA down to a very low level; OR abiraterone was started when the cancer was already castration-resistant and lasted 6 months or longer, and reduced PSA by at least 50%
  • People who are in generally good physical condition and able to carry out everyday activities with no or minimal limitations (confirm with trial site what this score means for individual circumstances)

Who may not be able to join:

  • People who have had cancer spread to the brain, have had seizures, or have a condition that increases the risk of seizures
  • People who have previously taken an experimental type of drug called a BET inhibitor, including in a previous version of this trial or in a trial of a drug called ZEN003694
  • People who have previously been treated with certain newer hormone-blocking drugs such as enzalutamide, apalutamide, darolutamide, or proxalutamide (older hormone-blocking drugs such as bicalutamide, nilutamide, or flutamide do not count toward this)
  • People who have had chemotherapy while their cancer was in the castration-resistant stage (chemotherapy given earlier, when the cancer was still hormone-sensitive, may be allowed if the last dose was at least 6 months before starting the study drug)
  • People who have received any cancer treatment within 2 weeks, or within a timeframe based on how long a specific drug stays in the body (whichever is shorter), before starting the study drug
  • People who have received testosterone treatment since stopping abiraterone
  • People who still have significant side effects (above a mild level) from previous cancer treatments, not including hair loss or nerve-related symptoms, at the time of joining the trial
  • People who have had radiation therapy within 2 weeks before starting the study drug

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 20 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 587-390-7865

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Zenith Epigenetics
Registry
ClinicalTrials.gov
Start date
8 September 2021
Est. completion
1 December 2026

Where this trial is recruiting

🇨🇳 China 🇺🇸 United States

Primary endpoints

Cohort A: Radiographic progression-free survival (rPFS) by BICR

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov