Safety and Tolerability Analysis of Combining Desmopressin With Docetaxel for the Treatment of Castration-Resistant Prostate Cancer

Exclusion Criteria

• •A subject will not be eligible for inclusion in this study if any of the following criteria apply:
• •1. Known Desmopressin intolerability.
• •2. Any state of known congestive heart disease (CHF class \>1).
• •3. Sodium blood levels \< 135 mEq/ml at enrollment.
• •4. Eastern Cooperative Oncology Group (ECOG) performance status \>1.
• •5. Moderate or severe chronic kidney disease (eGFR \<60 mL/min).
• •6. Prior use of docetaxel for CRPC.
• •7. ≤30 days prior to study treatment received or had:
• •1. Transfusion (platelets or red blood cells), or hematopoetic growth factors;
• •2. Any type of chemotherapy;
• •3. Any form of hormonal treatment with the exception of the continuous GnRH analogues required to maintain castrate state;
• •4. Corticosteroid treatment equivalent to \>10 mg of Prednisone orally daily;
• •5. An investigational agent for prostate cancer;
• •6. Ongoing Desmopressin therapy at enrollment;
• •7. Major surgery.
• •8. Current use of: Clofibrate, Chlorpropamide, Carbamazepine, Demeclocycline, Lithium, or Norepinephrine.
• •9. History of or current documented brain metastasis or carcinomatous meningitis, treated or untreated (brain imaging for asymptomatic subjects is not required).
• •10. Current symptomatic cord compression requiring surgery or radiation therapy (once successfully treated and there has been no progression, subjects are eligible for the study).
• •11. Uncontrolled medical conditions such as diabetes mellitus, angina pectoris, serious cardiac arrhythmia, severe hypertension, or active infection requiring systemic antibiotics, or any event such as myocardial infarction, cerebrovascular accident, or pulmonary embolism within 3 months prior to protocol therapy, as well as any significant concurrent medical illness that in the opinion of the Investigator would preclude protocol therapy.