Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 12:05 AM
Study NCT ID:
NCT05192694
Status:
UNKNOWN
Last Update Posted:
2022-03-11
First Post:
2021-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Fapi-pet 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Exploratory prospective cohort study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-10', 'studyFirstSubmitDate': '2021-12-07', 'studyFirstSubmitQcDate': '2022-01-13', 'lastUpdatePostDateStruct': {'date': '2022-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positive predictive value on a lesion level', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Positive predictive value of FAPI-PET on a lesion level using histopathology or confirmatory imaging as ground truth'}], 'secondaryOutcomes': [{'measure': 'Positive predictive value on a patient level', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Positive predictive value of FAPI-PET on a patient level using histopathology or confirmatory imaging as ground truth'}, {'measure': 'To assess the biodistribution of FAPI PET signal in comparison to PSMA-PET signal', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'To explore and compare the biodistribution and signal level of FAPI-PET and PSMA-PET'}, {'measure': 'To assess the biodistribution of FAPI and PSMA PET signal in comparison to histology', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'To explore the biodistribution and signal level of FAP-PET and PSMA-PET in correlation to reference histology (lesion volume and grade in radical prostatectomy specimen and lymphadenectomy specimen)'}, {'measure': 'To assess the biodistribution of FAPI and PSMA PET signal in comparison to immunohistochemistry', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'To explore the biodistribution and signal level of FAPI-PET and PSMA-PET in correlation to tissue protein levels of:\n\n1. FAP and PSMA\n2. Markers of reactive stroma and CAFs\n3. Neuregulin-1\n4. Androgen receptor signalling pathway'}, {'measure': 'To assess the biodistribution of FAPI and PSMA PET signal in comparison to biomarkers in "wet" samples', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'To correlate FAPI-PET and PSMA-PET biodistribution and signal level to:\n\n1. Postoperative serum biomarker levels (e.g., PSA, afos)\n2. cfDNA/RNA levels in peripheral blood\n3. Urinary exosome status for markers of reactive stroma\n4. Biochemical recurrence'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PET', 'PSMA', 'FAP', 'radical prostatectomy', 'novel antiandrogen', 'enzalutamide', 'apalutamide', 'FAPi', 'exosome'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.hucc.fi', 'label': 'study group website'}]}, 'descriptionModule': {'briefSummary': 'The investigators explore the biodistribution of FAPI-PET expression in primary high-risk prostate cancer in men undergoing RALP and eLND and in men with metastatic PCa about to start next generation antiandrogen.', 'detailedDescription': 'This is an exploratory cohort study comprised of men with clinically localized or locally advanced high-risk prostate cancer (GG 3-5, cT2-cT3, Nx, M0) managed by RALP and eLND and men with metastatic (mHSPC or mCRPC) prostate cancer scheduled to start NHT along clinical care pathway (e.g., apalutamide, enzalutamide) at HUS Helsinki University Hospital and Helsinki University, Finland.\n\nMen identified along routine clinical care as candidates for the study will be asked to consent.\n\nOnce consented, patients will undergo PSMA-PET imaging instead of conventional imaging (CT and bone scan) and experimental FAPI-PET imaging. Furthermore, biomarker samples will be obtained before and after treatment (surgery or novel antiandrogen) and surgical specimen will be processed for routine pathological evaluation and multiplex IHC studies. Serum samples will be tested for PCa biomarkers (e.g., PSA, NSE, CgA) and cfDNA. Urine will be processed and extracellular vesicles (exosomes) isolated and markers of reactive stroma will be sought for.\n\nRadical prostatectomy and novel hormonal treatment will be done according to current recommendations and guidelines in Finland.\n\nPostoperatively, patients will be followed with PSA every six months. Biochemical recurrence will be set at PSA of 0.2 ug/l or higher.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMen scheduled for radical prostatectomy\n\n* Age over 18 years\n* GG 3-5, cT2-cT3, Nx, M0 prostate cancer\n* no contraindication to PSMA - or FAPI-PET\n* willing to undergo study related procedures (imaging and laboratory tests) Men scheduled for novel antiandrogen\n* Age over 18 years\n* GG2-5, cT2-4, N0-1, M1\n* hormone sensitive or castration resistant prostate cancer\n\nExclusion Criteria:\n\n* Not willing or capable to undergo study related procedures'}, 'identificationModule': {'nctId': 'NCT05192694', 'acronym': 'FAPIPETPCA', 'briefTitle': 'Evaluation of Fapi-pet in Prostate Cancer.', 'organization': {'class': 'OTHER', 'fullName': 'Helsinki University Central Hospital'}, 'officialTitle': 'Evaluation of Fapi-pet in Prostate Cancer', 'orgStudyIdInfo': {'id': 'HUS/2997/2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'FAPI PET', 'description': 'Prospective single arm cohort', 'interventionNames': ['Procedure: Computed tomography']}], 'interventions': [{'name': 'Computed tomography', 'type': 'PROCEDURE', 'otherNames': ['68-Ga-FAPI-4 PET/CT'], 'description': 'Positron Emission Tomography', 'armGroupLabels': ['FAPI PET']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00029', 'city': 'Helsinki', 'state': 'Uusimaa', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Antti s Rannikko, MD, PhD', 'role': 'CONTACT', 'email': 'antti.rannikko@hus.fi'}, {'name': 'Tuomas Mirtti, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Henrikki Santti, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Anssi Petas, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mika Matikainen, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tuomas Kilpeläinen, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Teijo Pellinen, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Antti Loimaala, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Oleg Kerro, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kim Bergström, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Teija Koivula, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Antti Rannikko, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Helsinki University Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'centralContacts': [{'name': 'Antti S Rannikko, MD, PhD', 'role': 'CONTACT', 'email': 'antti.rannikko@hus.fi', 'phone': '+358405470208'}], 'overallOfficials': [{'name': 'Antti S Rannikko, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Helsinki University Central Hospital'}]}, 'ipdSharingStatementModule': {'url': 'http://hucc.fi', 'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'during the study', 'ipdSharing': 'YES', 'description': 'Study protocol', 'accessCriteria': 'publically available at the study group web site once study starts.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Helsinki', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Antti Rannikko', 'investigatorAffiliation': 'Helsinki University Central Hospital'}}}}