11C or 18F-Choline PET/CT and Whole Body MRI for Staging and Response Prediction in Metastatic Hormono-Sensitive Prostate Cancer Patients Receiving Enzalutamide

• Status: Completed
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

The aim of the study is to assess the clinical utility of 11C or 18F-Choline Positron Emission Tomography (PET)/Computed Tomography (CT) scan, Whole Body Magnetic Resonance Imaging (MRI) versus conventional bone scan and prostate-specific antigen (PSA) measurements in response prediction to treatment with Enzalutamide in Hormono-Sensitive Metastatic Prostate Cancer patients.

The study will assess how these 2 imaging modalities perform compared to traditional serial PSA measurements and bone scan in assessing metastatic tumour load, progressive disease and response to treatment with Enzalutamide.

In addition measurements of serially collected circulating tumour cell (CTC) samples, cell-free tumour DNA and RNA will be performed in order to evaluate their predictive value in terms of response measurement.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The European Uro-Oncology Group
• Collaborator: Centre for Human Drug Research, Netherlands
• Treatments: Choline

Criteria

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).