An exploratory study to assess the efficacy using imaging of oral enzalutamide in patients with therapy-resistant prostate cancer who have not been treated with androgen deprivation.
- Conditions
- Patients with Metastatic Prostate Cancer who have never been treated with Androgen Deprivation TherapyMedDRA version: 18.0Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
- Registration Number
- EUCTR2014-001162-10-NL
- Lead Sponsor
- European Uro- Oncology Group (EUOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- 60
Adult metastatic hormone-naïve prostate cancer patients with progressive metastatic disease requiring treatment and who have at least one measurable metastasis on either PET/CT or WB MRI or both.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35
Previous androgen deprivation therapy / Known or suspected brain metastasis or active leptomeningeal disease / Evidence of clinically relevant liver/kidney disease/bone marrow failure / history of seizure or any condition that may predispose to seizure / history of loss of consciousness or transient ischemic attack within 12 months of enrollment / Contra-indication for MRI (e.g. pacemaker).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 1. To evaluate the feasibility of 18F-FDG PET/CT, or WB MRI or both to determine metastatic tumour load before and after treatment with Enzalutamide in patients with metastatic prostate cancer. <br>2. To evaluate 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 in these patients.;Secondary Objective: Not applicable;Primary end point(s): Progression-Free Survival (PFS) at 6 and 12 months;Timepoint(s) of evaluation of this end point: 6 and 12 months
- Secondary Outcome Measures
Name Time Method