A Phase 2 interventional study of Enzalutamide and 18-FDG PET/CT in Prostate Cancer Metastatic, sponsored by The European Uro-Oncology Group. Completed at 1 site in Netherlands. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-14.
Sponsored by The European Uro-Oncology Group · Phase 2, Interventional, and Treatment
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.
Castration-resistant prostate cancer patients eligible for 2nd 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 18F-FDG PET/CT scans at baseline, 2 weeks, 2 and 6, 9 and 12 months after starting androgen receptor-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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 66 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
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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.
Drug: Enzalutamide · Device: 18-FDG PET/CT · Device: Whole body MRI · Device: Bone scan
Also known as: Xtandi
Progression-Free Survival (PFS) at 6 months
Defined as the time from the date of randomization to the date of radiological progression or death (patients will be followed beyond the fixed time point of 12 months for continued response cq recurrence, but 12 month is the last fixed primary endpoint assessment). Radiological progression is defined by any of the following criteria: * Soft tissue lesions: Progressive disease on 18F-FDG PET/CT or 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 18F-FDG 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 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).
Time frame: 6 months
Progression-Free Survival (PFS) at 12 months
Defined as the time from the date of randomization to the date of radiological progression or death (patients will be followed beyond the fixed time point of 12 months for continued response cq recurrence, but 12 month is the last fixed primary endpoint assessment). Radiological progression is defined by any of the following criteria: * Soft tissue lesions: Progressive disease on 18F-FDG PET/CT or 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 18F-FDG 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 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).
Time frame: 12 months
Biochemical (PSA) response defined as prostate-specific antigen (PSA) nadir.
Response as PSA nadir.
Time frame: 12 months
PSA progression. PSA kinetics measured by PSA doubling time (regular PSA measurements).
PSA doubling time
Time frame: 12 months
Progression of bone lesions detected with bone scan according to Prostate Cancer Working Group 2 (PCWG2) criteria.
Progression of bone lesions
Time frame: 6 and 12 months
Radiologically confirmed spinal cord compression or pathological fracture due to malignant progression.
Radiological assessment of spinal cord compression or pathological fracture
Time frame: 6 and 12 months
Occurrence of Symptomatic Skeletal Events (SSE) evaluated by combination of clinical and radiological assessments
Assessment of 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
Time frame: 12 months
Number of participants with change in CTC measurements correlated to radiological PFS.
Assessment of radiological PFS
Time frame: 6 and 12 months
Percent change from baseline in serum concentration of circulating testosterone (T).
Change in circulating testosterone
Time frame: 12 months
Percent change from baseline in serum concentration of dihydrotestosterone (DHT).
Change in serum concentration of dihydrotestosterone
Time frame: 12 months
Percent change from baseline in serum concentration of sex hormone binding globulin (SHBG).
Changes of SHBG
Time frame: 12 months
Percent change from baseline in serum concentration of androstenedione (A).
Changes of androstenedione from baseline
Time frame: 12 months
Number of participants with changes in biomarkers of bone turnover correlated to PSA.
Changes in biomarkers
Time frame: 12 months
Number of participants with adverse events (AEs) and serious adverse events (SAEs) leading to treatment discontinuation.
Assessment of AE and SAEs
Time frame: 6 and 12 months
Time to symptomatic progression (including death due to prostate cancer).
Time to progression
Time frame: 12 months
Time to initiation of salvage systemic therapy, including chemotherapy, or palliative radiation.
Time to chemotherapy or palliative radiation.
Time frame: 12 months
Quality of life measured by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire.
Quality of life assessment
Time frame: 6 and 12 months
Quality of life measured by the EuroQol 5-Dimension QoL Instrument (EQ-5D).
Quality of life assessment
Time frame: 6 and 12 months
Changes in Karnofsky score
Changes in Karnofsky score
Time frame: 6 and 12 months
Changes in visual analogue scale (VAS) for tumour-related pain.
Pain changes from baseline (QoL)
Time frame: 6 and 12 months
Changes in bone mineral density (BMD) as measured by Dual-energy X-ray absorptiometry (DXA) scan.
Bone mineral density changes
Time frame: 6 and 12 months
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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