Clinical trial for Metastatic Castration-resistant Prostate Cancer
Official title The COSMYC Trial (COmbined Suppression of MYC)
ClinicalTrials.gov ID: NCT06922318
What this study is testing
What is ZEN-3694?
ZEN-3694 is an investigational oral capsule being studied as a potential treatment for metastatic castration‑resistant prostate cancer. ZEN-3694 is designed to selectively modulate the androgen receptor, aiming to affect tumor growth.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether giving testosterone with ZEN‑3694, then adding enzalutamide with ZEN‑3694, can reduce tumor size in men whose prostate cancer no longer responds to hormone therapy.
- Who it's for
- You may be able to join if you are a man with metastatic castration‑resistant prostate cancer that has tried other treatments.
- What's involved
- You would receive a combination of testosterone and ZEN‑3694 for a period, then switch to enzalutamide plus ZEN‑3694. You will have regular visits and scans to check tumor size.
- Time commitment
- The study lasts about 12 months, with visits every few weeks for medication and imaging.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Eastern Cooperative Oncology Group (ECOG) Performance status ≤2.
- Age ≥18 years.
- 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).
You likely can't join if
- Pain due to metastatic prostate cancer requiring treatment intervention with opioid pain medication.
- ECOG Performance status ≥3
- Requirement for urinary self-catheterization for voiding due to obstruction secondary to prostatic enlargement well documented to be due to prostate...
- Active uncontrolled infection. Patients with a history of HIV/AIDS may be eligible if cluster of differentiation 4 (CD4)+ T cell counts are ≥ 350...
- Any condition or mental impairment that may compromise the ability to give informed consent, patient's safety or compliance with study requirements...
- Patients receiving anticoagulation therapy with warfarin, rivaroxaban, or apixaban are not eligible for study.
See the full eligibility criteria
- Eastern Cooperative Oncology Group (ECOG) Performance status ≤2.
- Age ≥18 years.
- 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.
- 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...
- Screening PSA must be ≥ 1.0 ng/mL.
- Patients with soft tissue lesion amenable to biopsy must agree to biopsy collection pre-treatment and at a defined point on treatment to perform tumor tissue analysis.
- Prior treatment with Provenge vaccine, 223 Radium (Xofigo), poly(ADP-ribose) polymerase (PARP) inhibitors, taxane chemotherapy, Pluvicto, antiandrogens (including enzalutamide, darolutamide, and apalutamide), and...
- Prior treatment with BAT is allowed if the patient has progressed on an AR-axis inhibitor (i.e. abiraterone or antiandrogen) since BAT treatment.
- Patients must be withdrawn from second-generation AR-axis inhibitor (Abiraterone, Enzalutamide, Darolutamide, or Apalutamide) for ≥ 2 weeks.
- Attempts must be made to wean patients off prednisone prior to starting therapy. Patients who cannot be weaned due to symptoms may continue on lowest dose of prednisone achieved during weaning period.
- Bilirubin \< 2.5 times institutional upper limit of normal (ULN)
- Aspartate Transferase (AST) (SGOT) and Alanine Transaminase (ALT) (SGPT) \< 2.5 times ULN
- Acceptable renal function: a. Serum creatinine \<2.5 times ULN
- Absolute neutrophil count (ANC) ≥ 1000 cells/mm3 (1.5 ×109/L)
- Platelet count ≥ 100,000 platelet/mm3 (100 ×109/L)
- Hemoglobin ≥ 7.5 g/dL.
- Ability to understand and willingness to sign a written informed consent document.
- Sexually active participants with female partners of childbearing potential are eligible to participate if they agree to follow 1 of the following methods of contraception consistently, starting from screening, during...
- Sexually active participants with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse; or use a male condom during each episode of penile penetration during the study
- Patients with soft-tissue disease amenable to biopsy as determined by treatment Radiology must agree to serial biopsies as per the study schedule to be eligible.
- Pain due to metastatic prostate cancer requiring treatment intervention with opioid pain medication.
- ECOG Performance status ≥3
- Requirement for urinary self-catheterization for voiding due to obstruction secondary to prostatic enlargement well documented to be due to prostate cancer or benign prostatic hyperplasia (BPH).
- Active uncontrolled infection. Patients with a history of HIV/AIDS may be eligible if cluster of differentiation 4 (CD4)+ T cell counts are ≥ 350 cell/ul, they have had no opportunistic infection within the past 12...
- Any condition or mental impairment that may compromise the ability to give informed consent, patient's safety or compliance with study requirements as determined by the investigator.
- Patients receiving anticoagulation therapy with warfarin, rivaroxaban, or apixaban are not eligible for study. [Patients on enoxaparin or edoxaban are eligible for study.
- Patients are excluded with prior history of a thromboembolic event within the last 12 months that are not being treated with systemic anticoagulation.
- Hematocrit \>51%, untreated severe obstructive sleep apnea, uncontrolled or poorly controlled heart failure [per Endocrine Society Clinical Practice Guidelines (34)]
- Patients allergic to sesame seed oil or cottonseed oil are excluded.
- Major surgery (i.e. as defined by treating physician) within 3 weeks before screening, or has not fully recovered from prior surgery (i.e., unhealed wound).
The study team makes the final eligibility decision.
Where it is enrolling
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Baltimore, Maryland, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.