F-choline PET in Early Response Assessment for Castration Resistant Prostatic Cancer (PRECHOL)

This is an interventional diagnostic trial for Castration-resistant Prostate Cancer focused on measuring castration-resistant prostate cancer, abiraterone acetate, enzalutamide, choline pet Read More

Inclusion Criteria:

• Age > 18 years
• Eastern Cooperative Oncology Group (ECOG)performance status score of 2 or less
• Histologically or cytologically confirmed adenocarcinoma prostate cancer without neuroendocrine component (component with minority neuroendocrine) or small cell, or neuroendocrine cells or small minority component prostate who underwent surgical or medical castration
• Disease progression during or after a docetaxel-based chemotherapy
• serum testosterone level of 50 ng per deciliter or less (≤2.0 nmol per liter)
• Biologic criteria :
• platelets ≥ 100 000/μl,
• Creatinine <1.5 x upper limit or creatinine clearance ≥ 60 ml / min,
• Serum potassium ≥ 3.5 mmol / l,
• Bilirubin <1.5 x upper limit of normal (ULN)
• hemoglobin ≥ 9.0 g / dl without any transfusion.

Exclusion Criteria:

• abnormal aminotransferase levels (levels of aspartate aminotransferase or alanine aminotransferase that were ≥2.5 times the upper level of the normal range; patients with known liver metastasis who had levels of aspartate aminotransferase or alanine aminotransferase that were ≤5 times the upper level of the normal range were eligible to participate
• previous therapy with ketoconazole
• serious coexisting nonmalignant disease :
• active or symptomatic viral hepatitis or chronic liver disease,
• uncontrolled hypertension,
• a history of pituitary or adrenal dysfunction,
• clinically significant heart disease