Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT05245435
Status:
WITHDRAWN
Last Update Posted:
2023-03-20
First Post:
2021-09-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diagnostic and Prognostic Accuracy of FDHT-PET and Liquid Biopsies in Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073890', 'term': 'Liquid Biopsy'}], 'ancestors': [{'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Recruitment was not possible with the chosen inclusion/exclusion criteria at our Institution.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-16', 'studyFirstSubmitDate': '2021-09-28', 'studyFirstSubmitQcDate': '2022-02-04', 'lastUpdatePostDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FDHT total receptor expression (TRE) volume parameters compared to clinical follow-up', 'timeFrame': 'through study completion, an average of 2 years'}, {'measure': 'FDHT total receptor expression (TRE) volume parameters compared to course of disease', 'timeFrame': 'through study completion, an average of 2 years'}, {'measure': 'FDHT total receptor expression (TRE) volume parameters compared to androgen resistance', 'timeFrame': 'through study completion, an average of 2 years'}, {'measure': 'FDHT total receptor expression (TRE) volume parameters compared to liquid biopsy parameters', 'timeFrame': 'through study completion, an average of 2 years'}, {'measure': 'FDHT total receptor expression (TRE) volume parameters compared to IHC patterns', 'timeFrame': 'through study completion, an average of 2 years'}, {'measure': 'FDHT total receptor expression (TRE) volume parameters compared to stage of disease', 'timeFrame': 'through study completion, an average of 2 years'}, {'measure': 'CTC count before and after treatment', 'timeFrame': 'through study completion, an average of 2 years'}, {'measure': 'ctDNA abundance before and after treatment', 'timeFrame': 'through study completion, an average of 2 years'}, {'measure': '(Quantitative) IHC analysis of androgen specific receptor expression levels (FDHT) in tissue', 'timeFrame': 'through study completion, an average of 2 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'Depending on the cohort of the study the diagnostic and prognostic accuracy and health economics considerations of \\[18F\\]-fluoro-5α-dihydrotestosterone (FDHT)- positron emission tomography (PET) and/or circulating tumor cells in prostate cancer patients are studied.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nCOHORT A:\n\n* Age 18-75 years\n* Histologically confirmed oligometastatic adenocarcinoma of the prostate (defined as ≤5 metastases in lymph node (LN) or bone)\n* Eastern Cooperative Oncology Group (ECOG) Performance Status grade 0 or 1\n* Planned cytoreductive radical prostatectomy\n* ≤ 5 osseous and/or lymph node metastasis\n* Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to study participation\n* Willingness and ability to comply with scheduled visits, treatment plans, laboratory and radiographic assessments, questionnaire completion and other study procedures\n\nCOHORT B:\n\n* Age 18-75 years\n* Histologically confirmed oligometastatic adenocarcinoma of the prostate\n* Newly diagnosed metastatic hormone-sensitive disease\n* planned therapy with androgen deprivation therapy, and/or treatment with abiraterone acetate, and/or enzalutamide and/or docetaxel\n* Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.\n* Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to study participation\n* Willingness and ability to comply with scheduled visits, treatment plans, laboratory and radiographic assessments, questionnaire completion and other study procedures\n\nCOHORT C:\n\n* Age 18-75 years\n* Histologically confirmed oligometastatic adenocarcinoma of the prostate\n* Metastatic castration-resistant disease\n* Not pre-treated with enzalutamide or abiraterone acetate\n* Planned therapy with abiraterone acetate, or enzalutamide\n* Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.\n* Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to study participation\n* Willingness and ability to comply with scheduled visits, treatment plans, laboratory and radiographic assessments, questionnaire completion and other study procedures\n\nCOHORT D (control group for Cohort A):\n\n* Age 18-75 years\n* Histologically confirmed oligometastatic adenocarcinoma of the prostate (defined as ≤5 metastases in lymph node (LN) or bone)\n* Hormone-sensitive prostate cancer\n* Refused cytoreductive radical prostatectomy\n* Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to study participation\n* Willingness and ability to comply with scheduled visits, treatment plans, laboratory and radiographic assessments, questionnaire completion and other study procedures\n\nExclusion Criteria:\n\nCOHORT A:\n\n* HIV positive\n* Any contraindication for surgery\n* Any other condition that, in the opinion of the Investigator, would impair the patient's ability to comply with study procedures.\n* Any contraindication for performing a PET/MRI scan\n* Patient's not eligible for the size of the PET/MRI gantry\n\nCOHORTS B and C:\n\n* HIV positive\n* Any contraindication for tissue biopsy (if tissue biopsy is planned)\n* Any other condition that, in the opinion of the Investigator, would impair the patient's ability to comply with study procedures.\n* Any contraindication for performing a PET/MRI scan\n* Patient's not eligible for the size of the PET/MRI gantry\n\nCOHORT D (control group for Cohort A):\n\n* HIV positive\n* Any other condition that, in the opinion of the Investigator, would impair the patient's ability to comply with study procedures.\n* Any contraindication for performing a PET/MRI scan\n* Patient's not eligible for the size of the PET/MRI gantry"}, 'identificationModule': {'nctId': 'NCT05245435', 'briefTitle': 'Diagnostic and Prognostic Accuracy of FDHT-PET and Liquid Biopsies in Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Diagnostic and Prognostic Accuracy and Health Economics Considerations of [18F]-Fluoro-5α-dihydrotestosterone (FDHT)- Positron Emission Tomography (PET) and Circulating Tumor Cells - a Pilot Study in Patients Undergoing Cytoreductive Prostatectomy in the Setting of Primary Oligometastatic Prostate Cancer, in Patients With Primary Metastatic Hormone-sensitive Prostate Cancer, and in Patients With Metastatic Castration Resistant Prostate Cancer', 'orgStudyIdInfo': {'id': 'FDHTProstate_Protocol_V3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'planned to undergo cytoreductive prostatectomy', 'description': 'planned to undergo cytoreductive prostatectomy', 'interventionNames': ['Diagnostic Test: liquid biopsies']}, {'type': 'OTHER', 'label': 'newly diagnosed metastatic hormone-sensitive prostate cancer patients', 'description': 'planned to undergo androgen deprivation therapy, and/or treatment with abiraterone acetate, and/or enzalutamide and/or docetaxel', 'interventionNames': ['Diagnostic Test: FDHT-PET Scan', 'Diagnostic Test: liquid biopsies']}, {'type': 'OTHER', 'label': 'metastatic castration-resistant prostate cancer patients', 'description': 'who were not pre-treated with enzalutamide or abiraterone acetate and planned treatment with those drugs', 'interventionNames': ['Diagnostic Test: FDHT-PET Scan', 'Diagnostic Test: liquid biopsies']}, {'type': 'OTHER', 'label': 'primary oligometastatic hormone-sensitive prostate cancer patients', 'description': 'who refuse to undergo cytoreductive radical prostatectomy will serve as control group', 'interventionNames': ['Diagnostic Test: liquid biopsies']}], 'interventions': [{'name': 'FDHT-PET Scan', 'type': 'DIAGNOSTIC_TEST', 'description': '\\[18F\\]-fluoro-5α-dihydrotestosterone (FDHT)- positron emission tomography (PET)', 'armGroupLabels': ['metastatic castration-resistant prostate cancer patients', 'newly diagnosed metastatic hormone-sensitive prostate cancer patients']}, {'name': 'liquid biopsies', 'type': 'DIAGNOSTIC_TEST', 'description': 'circulating tumor cell count and circulating tumor DNA abundance in blood of prostate cancer patients', 'armGroupLabels': ['metastatic castration-resistant prostate cancer patients', 'newly diagnosed metastatic hormone-sensitive prostate cancer patients', 'planned to undergo cytoreductive prostatectomy', 'primary oligometastatic hormone-sensitive prostate cancer patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Markus Zeitlinger', 'investigatorAffiliation': 'Medical University of Vienna'}}}}