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New treatment option 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 medicine, given as a pill taken by mouth, being studied as a potential treatment for metastatic castration-resistant prostate cancer.
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 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.
- 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. [Patients on enoxaparin or edoxaban...
See the full eligibility criteria
Who can join
- 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. Pylarify) may be substitute for CT scan if evidence of metastatic...
- 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.
- Acceptable liver function:
- 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
- Acceptable hematologic status:
- 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.
What rules you out
- 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). Patients with indwelling...
- 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 on warfarin, rivaroxaban, or apixaban...
- 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). Note: people with planned surgical procedures to be conducted...
The study team makes the final eligibility decision.
Where it's taking place
- 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 - 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?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.