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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C540278', 'term': 'enzalutamide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-06', 'studyFirstSubmitDate': '2016-06-18', 'studyFirstSubmitQcDate': '2016-06-23', 'lastUpdatePostDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-Free Survival (PFS) at 6 and 12 months.', 'timeFrame': '6 and 12 months', 'description': 'Radiological progression is defined by any of the following criteria:\n\n* 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.\n* 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).'}], 'secondaryOutcomes': [{'measure': 'Biochemical response defined as prostate-specific antigen (PSA) nadir', 'timeFrame': '12 months', 'description': 'Assessment of nadir PSA'}, {'measure': 'PSA progression. PSA kinetics measured by PSA doubling time (regular PSA measurements)', 'timeFrame': '12 months', 'description': 'PSA doubling time'}, {'measure': 'Progression of bone lesions detected with bone scan according to Prostate Cancer Working Group 2 (PCWG2) criteria', 'timeFrame': '6 and 12 months', 'description': 'Bone lesions progression'}, {'measure': 'Radiologically confirmed spinal cord compression or pathological fracture due to malignant progression', 'timeFrame': '6 and 12 months', 'description': 'Assessment of spinal cord compression or pathological fracture'}, {'measure': 'Occurrence of Symptomatic Skeletal Events (SSE) evaluated by combination of clinical and radiological assessments', 'timeFrame': '12 months', 'description': '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'}, {'measure': 'Circulating tumour cell (CTC) measurements and comparison with radiological PFS at 6 and 12 months', 'timeFrame': '6 and 12 months', 'description': 'Assessment of CTC'}, {'measure': 'Percent change from baseline in serum concentration of circulating testosterone (T)', 'timeFrame': '12 months', 'description': 'Changes in testosterone from baseline'}, {'measure': 'Percent change from baseline in serum concentration of dihydrotestosterone (DHT)', 'timeFrame': '12 months', 'description': 'Changes in dihydrotestosterone from baseline'}, {'measure': 'Percent change from baseline in serum concentration of sex hormone binding globulin (SHBG)', 'timeFrame': '12 months', 'description': 'Changes in sex hormone binding globulin'}, {'measure': 'Percent change from baseline in serum concentration of androstenedione (A)', 'timeFrame': '12 months', 'description': 'Changes in androstenedione from baseline'}, {'measure': 'Number of participants with changes in biomarkers of bone turnover correlated to PSA', 'timeFrame': '12 months', 'description': 'Changes in biomarkers of bone turnover correlated to PSA'}, {'measure': 'Number of participants with adverse events (AEs) and serious adverse events (SAEs) leading to treatment discontinuation', 'timeFrame': '6 and 12 months', 'description': 'Assessment of AE and SAEs'}, {'measure': 'Time to symptomatic progression (including death due to prostate cancer)', 'timeFrame': '12 months', 'description': 'Time to progression'}, {'measure': 'Time to first radiological or symptomatic progression', 'timeFrame': '6 and 12 months', 'description': 'Time to first radiological or symptomatic progression'}, {'measure': 'Time to initiation of salvage systemic therapy, including chemotherapy, or palliative radiation', 'timeFrame': '12 months', 'description': 'Time to chemotherapy or palliative radiation'}, {'measure': 'Quality of life measured by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire', 'timeFrame': '6 and 12 months', 'description': 'Quality of Life measurement using questionnaires'}, {'measure': 'Quality of life measured by the EuroQol 5-Dimension QoL Instrument (EQ-5D)', 'timeFrame': '6 and 12 months', 'description': 'Quality of life measurement using questionnaire'}, {'measure': 'Changes in Sexual Function (IIEF)', 'timeFrame': '6 and 12 months', 'description': 'Changes in Sexual Function from baseline'}, {'measure': 'Changes in Karnofsky score', 'timeFrame': '6 and 12 months', 'description': 'Changes in Karnofsky score from baseline'}, {'measure': 'Changes in visual analogue scale (VAS) for tumour-related pain', 'timeFrame': '6 and 12 months', 'description': 'Changes in pain from baseline'}, {'measure': 'Changes in bone mineral density (BMD) as measured by Dual-energy X-ray absorptiometry (DXA) scan', 'timeFrame': '6 and 12 months', 'description': 'Changes in bone mineral density from baseline'}]}, 'conditionsModule': {'keywords': ['Hormono-Sensitive prostate cancer', 'Enzalutamide', 'Imaging', 'PET/CT', 'Whole body MRI', 'Circulating tumour cells', 'Cell-free tumour DNA'], 'conditions': ['Prostate Cancer Metastatic']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://euog.org/', 'label': 'The European Uro-Oncology Group'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nIn 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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male aged 18 years or older;\n* Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features;\n* Three consecutive rises of PSA, 1 week apart, resulting in two 50% increases over the nadir, with PSA of at least \\> 2 ng/mL but preferably \\>20 ng/mL;\n* Progressive disease defined by rising PSA levels plus by evidence of progressive and measurable soft tissue or bone disease by 11C or 18F-Choline PET/CT, Whole Body MRI or both;\n* No prior treatment with cytotoxic chemotherapy;\n* Eastern Cooperative Oncology Group (ECOG) score 0-2;\n* A life expectancy of at least 12 months;\n* Written informed consent;\n\nExclusion Criteria:\n\n* Treatment with androgen deprivation therapy with a gonadotropin-releasing hormone analogue, luteinizing hormone-releasing hormone antagonist, or bilateral orchiectomy within 6 months of enrolment (Day1 visit);\n* Treatment with anti-androgens such as bicalutamide, nilutamide or flutamide within 6 weeks of enrolment (Day 1 visit);\n* Treatment with 5-α reductase inhibitors (finasteride, dutasteride), estrogens, cyproterone acetate within 4 weeks of enrolment (Day 1 visit);\n* Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrolment;\n* Known or suspected brain metastasis or active leptomeningeal disease;\n* History of another malignancy within the previous 5 years other than curatively treated non melanomatous skin cancer;\n* Total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 2.5 times the upper limit of normal at the Screening visit;\n* Creatinine \\> 177 µmol/L (2 mg/dL) at the Screening visit;\n* Hemoglobin \\<6 mmol/L, White blood cells \\< 4.0 x 10\\^9/L, Platelets \\< 100 x 10\\^9/L;\n* History of seizure or any condition that may predispose to seizure. Also, history of loss of consciousness or transient ischemic attack within 12 months of enrolment (Day 1 visit);\n* Contra-indication for MRI (e.g. pacemaker).'}, 'identificationModule': {'nctId': 'NCT02815033', 'briefTitle': 'Imaging Staging and Response Prediction in Metastatic Hormono-Sensitive Prostate Cancer Patients Receiving Enzalutamide', 'organization': {'class': 'OTHER', 'fullName': 'The European Uro-Oncology Group'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'EudraCT Number: 2014-001162-10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Single arm', 'description': '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.', 'interventionNames': ['Drug: Enzalutamide', 'Procedure: 11C or 18F-Choline PET/CT', 'Procedure: Whole body MRI', 'Procedure: Bone scan']}], 'interventions': [{'name': 'Enzalutamide', 'type': 'DRUG', 'otherNames': ['Xtandi'], 'armGroupLabels': ['Single arm']}, {'name': '11C or 18F-Choline PET/CT', 'type': 'PROCEDURE', 'armGroupLabels': ['Single arm']}, {'name': 'Whole body MRI', 'type': 'PROCEDURE', 'armGroupLabels': ['Single arm']}, {'name': 'Bone scan', 'type': 'PROCEDURE', 'armGroupLabels': ['Single arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2333 ZA', 'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Leiden University Medical Center', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}], 'overallOfficials': [{'name': 'Susanne Osanto, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'The European Uro-Oncology Group (EUOG)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The European Uro-Oncology Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre for Human Drug Research, Netherlands', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}