Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2026-03-02 @ 4:04 PM
Study NCT ID:
NCT02815033
Status:
COMPLETED
Last Update Posted:
2022-04-14
First Post:
2016-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Imaging Staging and Response Prediction in Metastatic Hormono-Sensitive Prostate Cancer Patients Receiving Enzalutamide
Sponsor:
The European Uro-Oncology Group
Organization:
Study Overview
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)
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: