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)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Summary
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.
Description
The primary objectives of the study are first to determine if treatment with the combination of ZEN-3694 and Bipolar Androgen Therapy (i.e. BATZEN) will improve the progression-free survival in patients with metastatic castrate-resistant prostate cancer (mCRPC) compared with historical controls. The second primary objective is to determine if treatment with ZEN-3694 and Enzalutamide (i.e. ZENZA) after progression on Bipolar Androgen Therapy (BAT) will improve PSA-progression-free survival compared to historical controls. Asymptomatic patients with mCRPC without pain due to prostate cancer wil…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: 1. Eastern Cooperative Oncology Group (ECOG) Performance status ≤2. 2. Age ≥18 years. 3. Histologically-confirmed adenocarcinoma of the prostate. 4. Treated with continuous androgen ablative therapy (either surgical castration or LHRH agonist/antagonist). 5. Documented castrate level of serum testosterone (\<50 ng/dl). 6. 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…
Interventions
- DrugZEN-3694
One ZEN-3694 pill (48 mg) will be taken each day of each BATZEN cycle.
- DrugTestosterone cypionate
On day 1 of each BATZEN cycle testosterone cypionate (400 mg) injection to the buttocks will be administered.
- DrugEnzalutamide
Enzalutamide 160 mg (four 40 mg capsules) taken daily by mouth on each ZENZA cycle.
- DrugLuteinizing hormone-releasing hormone (LHRH) analogue
Patients will continue on ADT with LHRH agonist (i.e. Zoladex, Trelstar, Eligard or Lupron) or LHRH antagonist (Degarelix or Relugolix) if not surgically castrated throughout the duration of the study to inhibit endogenous testosterone production.
Location
- Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterBaltimore, Maryland