Imaging Staging and Response Prediction in Metastatic Hormono-Sensitive Prostate Cancer Patients Receiving Enzalutamide

This is an interventional treatment trial for Prostate Cancer Metastatic focused on measuring Hormono-Sensitive prostate cancer, Enzalutamide, Imaging, PET/CT, Whole body MRI, Circulating tumour cells, Cell-free tumour DNA Read More

Inclusion Criteria:

• Male aged 18 years or older;
• Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features;
• Three consecutive rises of PSA, 1 week apart, resulting in two 50% increases over the nadir, with PSA of at least > 2 ng/mL but preferably >20 ng/mL;
• Progressive disease defined by rising PSA levels plus by evidence of progressive and measurable soft tissue or bone disease by 11C or 18F-Choline PET/CT, Whole Body MRI or both;
• No prior treatment with cytotoxic chemotherapy;
• Eastern Cooperative Oncology Group (ECOG) score 0-2;
• A life expectancy of at least 12 months;
• Written informed consent;

Exclusion Criteria:

• Treatment with androgen deprivation therapy with a gonadotropin-releasing hormone analogue, luteinizing hormone-releasing hormone antagonist, or bilateral orchiectomy within 6 months of enrolment (Day1 visit);
• Treatment with anti-androgens such as bicalutamide, nilutamide or flutamide within 6 weeks of enrolment (Day 1 visit);
• Treatment with 5-α reductase inhibitors (finasteride, dutasteride), estrogens, cyproterone acetate within 4 weeks of enrolment (Day 1 visit);
• Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrolment;
• Known or suspected brain metastasis or active leptomeningeal disease;
• History of another malignancy within the previous 5 years other than curatively treated non melanomatous skin cancer;
• Total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 2.5 times the upper limit of normal at the Screening visit;
• Creatinine > 177 µmol/L (2 mg/dL) at the Screening visit;
• Hemoglobin <6 mmol/L, White blood cells < 4.0 x 10^9/L, Platelets < 100 x 10^9/L;
• History of seizure or any condition that may predispose to seizure. Also, history of loss of consciousness or transient ischemic attack within 12 months of enrolment (Day 1 visit);
• Contra-indication for MRI (e.g. pacemaker).