11C or 18F-Choline PET/CT and Whole Body MRI for Staging and Response Prediction in Metastatic Hormono-Sensitive Prostate Cancer Patients Receiving Enzalutamide
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|ClinicalTrials.gov Identifier: NCT02815033|
Recruitment Status : Active, not recruiting
First Posted : June 28, 2016
Last Update Posted : August 15, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Metastatic||Drug: Enzalutamide Procedure: 11C or 18F-Choline PET/CT Procedure: Whole body MRI Procedure: Bone scan||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||July 2015|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
Experimental: Single arm Subjects will receive 1 dd 160 mg Enzalutamide orally continuously until progressive disease occurs. Serial PSA measurements, PET/CT scans, Whole Body MRI, bone scans will be performed to assess metastatic tumour load, progressive disease and response to treatment.
Procedure: 11C or 18F-Choline PET/CT
Procedure: Whole body MRI
Procedure: Bone scan
- Progression-Free Survival (PFS) at 6 and 12 months. [ Time Frame: 6 and 12 months ]
Radiological progression is defined by any of the following criteria:
- Soft tissue lesions: Progressive disease on Choline (11C or 18F) PET/CT or Whole Body MRI by RECIST 1.1. Bone or bone marrow lesions: Progressive disease on PET/CT or MRI as evidenced by new lesions or an increase in size of 25% of the sum of target lesions.
- Conversion of the Choline (11C or 18F) PET signal of the metastases at 2 weeks, 2 or 6 months compared to baseline PET which by comparing it to PFS at 6 and 12 months may be an indicator or drug response. Radiological PFS at 6 and 12 months will be compared to a) PET signal conversion and to b) PSA measurements, and changes in number of lesions on the bone scan (conventional work up).
- Biochemical response defined as prostate-specific antigen (PSA) nadir [ Time Frame: 12 months ]
- PSA progression. PSA kinetics measured by PSA doubling time (regular PSA measurements) [ Time Frame: 12 months ]
- Progression of bone lesions detected with bone scan according to Prostate Cancer Working Group 2 (PCWG2) criteria [ Time Frame: 6 and 12 months ]
- Radiologically confirmed spinal cord compression or pathological fracture due to malignant progression [ Time Frame: 6 and 12 months ]
- Occurrence of Symptomatic Skeletal Events (SSE) evaluated by combination of clinical and radiological assessments [ Time Frame: 12 months ]SSE is defined as external beam radiation therapy to relieve skeletal pain, occurrence of a new symptomatic pathologic bone fracture, spinal cord compression, tumour-related orthopedic surgical intervention or change of anti-neoplastic therapy to treat bone pain
- Circulating tumour cell (CTC) measurements and comparison with radiological PFS at 6 and 12 months [ Time Frame: 6 and 12 months ]
- Percent change from baseline in serum concentration of circulating testosterone (T) [ Time Frame: 12 months ]
- Percent change from baseline in serum concentration of dihydrotestosterone (DHT) [ Time Frame: 12 months ]
- Percent change from baseline in serum concentration of sex hormone binding globulin (SHBG) [ Time Frame: 12 months ]
- Percent change from baseline in serum concentration of androstenedione (A) [ Time Frame: 12 months ]
- Number of participants with changes in biomarkers of bone turnover correlated to PSA [ Time Frame: 12 months ]
- Number of participants with adverse events (AEs) and serious adverse events (SAEs) leading to treatment discontinuation [ Time Frame: 6 and 12 months ]
- Time to symptomatic progression (including death due to prostate cancer) [ Time Frame: 12 months ]
- Time to first radiological or symptomatic progression [ Time Frame: 6 and 12 months ]
- Time to initiation of salvage systemic therapy, including chemotherapy, or palliative radiation [ Time Frame: 12 months ]
- Quality of life measured by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire [ Time Frame: 6 and 12 months ]
- Quality of life measured by the EuroQol 5-Dimension QoL Instrument (EQ-5D) [ Time Frame: 6 and 12 months ]
- Changes in Sexual Function (IIEF) [ Time Frame: 6 and 12 months ]
- Changes in Karnofsky score [ Time Frame: 6 and 12 months ]
- Changes in visual analogue scale (VAS) for tumour-related pain [ Time Frame: 6 and 12 months ]
- Changes in bone mineral density (BMD) as measured by Dual-energy X-ray absorptiometry (DXA) scan [ Time Frame: 6 and 12 months ]
- Early Health Technology Assessment to calculate cost-effectiveness of both diagnostic procedures [ Time Frame: 6 and 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02815033
|Leiden University Medical Center|
|Leiden, Netherlands, 2333 ZA|
|Study Chair:||Susanne Osanto, MD PhD||The European Uro-Oncology Group (EUOG)|