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

Prostate Cancer Metastatic Clinical Trial

Official title:
An Exploratory Phase 2, Open-label, Single-arm, Efficacy and Imaging Study of Oral Enzalutamide (XTANDI) Androgen Receptor (AR)-Directed Therapy in Hormono-Sensitive Patients With Metastatic Prostate Cancer (Hormono-sensitive Patients)

Clinical Trial 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.

Clinical Trial Description

Metastatic prostate cancer patients eligible for 1st line hormonal treatment will undergo treatment with Enzalutamide (XTANDI). Subjects will receive 1dd 160 mg Enzalutamide orally continuously until progressive disease occurs. All subjects will undergo Choline (11C or 18F)-PET/CT scans at baseline, 2 weeks, 2 and 6, 9 and 12 months after starting androgen receptor (AR)-directed treatment. All subjects will undergo Whole Body MRI at baseline, 6, 9 and 12 months. Bone scans will be performed at baseline, 3 months, 6 and 12 months. PSA will be measured at baseline and every 4 weeks thereafter until at 12 months. CTC counts and characteristics will be measured at baseline and during Enzalutamide treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02815033
Study type Interventional
Source The European Uro-Oncology Group
Contact
Status Completed
Phase Phase 2
Start date July 2015
Completion date December 2020
View Details
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