Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
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RecruitingPhase 2interventionalRules rewrite

Phase 2: testing ZEN-3694 for Metastatic Castration-resistant Prostate Cancer

This research is being done to determine if receiving the combination of testosterone and ZEN-3694 followed by the combination of enzalutamide plus ZEN-3694 will decrease the size of tumors in patients with prostate cancer that has become resistant to castration and other therapies. The investigators also want to determine if dosing first with the combination of testosterone and ZEN-3694 may cause enzalutamide and ZEN-3694 to work more effectively.

Official registry: https://clinicaltrials.gov/study/NCT06922318 · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · enrollment listed as 50

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are ZEN-3694, Testosterone cypionate, or Enzalutamide. The registry lists allocation as randomized. This research is being done to determine if receiving the combination of testosterone and ZEN-3694 followed by the combination of enzalutamide plus ZEN-3694 will decrease the size of tumors in patients with prostate cancer that has become resistant to castration and other therapies.

They plan to enroll about 50 people at Baltimore. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase II Study of Sequential Bipolar Androgen Therapy and ZEN-3694 in Sequence With Enzalutamide + ZEN-3694 in Asymptomatic Patients With Metastatic CRPC: The COSMYC Trial (COmbined Suppression of MYC)

Interventions: ZEN-3694, Testosterone cypionate, Enzalutamide, Luteinizing hormone-releasing hormone (LHRH) analogue

Primary outcome (registry wording): Clinical/radiographic progression free survival (PFS) with BATZEN

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Men only
  • Eastern Cooperative Oncology Group (ECOG) Performance status ≤2
  • Histologically-confirmed adenocarcinoma of the prostate
  • Treated with continuous androgen ablative therapy (either surgical castration or LHRH agonist/antagonist)
  • Documented castrate level of serum testosterone (\<50 ng/dl)
  • Metastatic disease radiographically documented by CT or bone scan. While CT scan is preferred, Prostate-Specific Membrane Antigen (PSMA) scan (e.g. Pylarify) may be substitute for CT scan if evidence of metastatic disease observed on the CT portion of the PSMA scan
  • Must have had disease progression while on a second-generation AR-axis inhibitor (Abiraterone, Enzalutamide, Darolutamide, or Apalutamide) based on:
  • PSA progression defined as an increase in PSA, as determined by 2 separate measurements taken at least 1 week apart i. And/ Or Radiographic disease progression, based on RECIST 1.1 in patients with measurable soft tissue lesions or PCWG3 for patients with bone disease

Public study contact (from the registry)

Samuel Denmeade, MD

410-733-3232

denmesa@jhmi.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT06922318 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06922318?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06922318?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary