18F-FDG PET/CT and Whole Body MRI for Staging and Response Prediction in Castration-resistant 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 18F-fluoro-deoxyglucose Positron Emission Tomography (PET)/Computed Tomography (CT) and Whole Body Magnetic Resonance Imaging (MRI) versus conventional bone scan and prostate-specific antigen (PSA) measurements in response prediction to treatment with Enzalutamide in castration-resistant 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 castration-resistant prostate cancer patients.

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: Fluorodeoxyglucose F18

Criteria

Inclusion Criteria:

• Male aged 18 years or older;

• Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features;

• Ongoing androgen deprivation therapy with a GnRH analogue or bilateral orchiectomy;

• Three consecutive rises of PSA, 1 week apart, resulting in two 50% increases over the nadir, with PSA of at least > 5 ng/mL but preferably >10 ng/mL;

• Progressive disease as defined by rising PSA levels plus by evidence of progressive and measurable soft tissue or bone disease by 18F-FDG PET/CT, Whole Body MRI or both;

• Castrate serum levels of testosterone < 50 ng/dL or < 1.7 nmol/L;

• Anti-androgen withdrawal for at least 6 weeks for bicalutamide, nilutamide or flutamide for at least 6 weeks;

• 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:

• 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 x10^9/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).