Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2025-12-26 @ 10:16 PM
Study NCT ID:
NCT07089550
Status:
RECRUITING
Last Update Posted:
2025-09-24
First Post:
2025-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PSMA PET for Treatment Response evaLuation of systemIC Therapies in prostAte caNcer (PELICAN)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1300}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2034-04-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-19', 'studyFirstSubmitDate': '2025-05-28', 'studyFirstSubmitQcDate': '2025-07-24', 'lastUpdatePostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2034-04-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of PSMA-avid lesions (count)', 'timeFrame': 'From baseline PET/CT through study completion, an average of 2 years', 'description': 'number of PSMA-avid lesions (count)'}, {'measure': 'metabolic tumor volume (MTV in cm 3)', 'timeFrame': 'From baseline PET/CT through study completion, an average of 2 years', 'description': 'metabolic tumor volume (MTV in cm 3)'}, {'measure': 'maximum standardized uptake value (SUVmax, dimensionless)', 'timeFrame': 'From baseline PET/CT through study completion, an average of 2 years', 'description': 'maximum standardized uptake value (SUVmax, dimensionless)'}, {'measure': 'mean standardized uptake value (SUVmean, dimensionless)', 'timeFrame': 'From baseline PET/CT through study completion, an average of 2 years', 'description': 'mean standardized uptake value (SUVmean, dimensionless)'}], 'secondaryOutcomes': [{'measure': 'Prediction of Treatment Response via PSMA PET', 'timeFrame': 'From baseline PET/CT through study completion, an average of 2 years', 'description': 'Predictive value of PSMA PET-derived parameters in forecasting patient response to systemic therapies (abiraterone, enzalutamide, apalutamide, darolutamide, docetaxel, cabazitaxel, olaparib, radiotherapy, 177-lutetium PSMA, 225-actinium PSMA). This will be assessed by correlating PSMA PET metrics with established clinical and radiological response criteria for each respective therapy.'}, {'measure': 'Comparative Analysis of Imaging Modalities', 'timeFrame': 'From baseline PET/CT through study completion, an average of 2 years', 'description': 'Incremental predictive and prognostic value of PSMA PET, when used in conjunction with standard imaging techniques (CT, MRI, bone scan). This will involve comparing the predictive accuracy of PSMA PET alone versus combined imaging approaches in predicting treatment outcomes and patient survival.'}, {'measure': 'Assessment of Tumor Volume Dynamics', 'timeFrame': 'From baseline PET/CT through study completion, an average of 2 years', 'description': 'Correlation between changes in PSMA PET-derived tumor volume (MTV) during the course of systemic treatment and patient clinical outcomes, including but not limited to, progression-free survival and overall survival. This will assess the utility of dynamic MTV changes as a surrogate marker for treatment response.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PSMA PET/CT', 'mCRPC', 'mHSPC'], 'conditions': ['PSMA Positive Tumors or Tumor Tissues', 'Prostate Cancer Metastatic']}, 'descriptionModule': {'briefSummary': 'This prospective clinical study aims to evaluate the predictive power of PSMA PET imaging in patients with advanced prostate cancer who are receiving systemic drug therapies.\n\nThe primary goal is to identify prognostic factors derived from PSMA PET imaging. These factors include the number of cancer lesions, the size of the tumor, and measurements known as SUVmax and SUVmean. By identifying these factors, the investigators aim to better group patients and predict those who may have a less favorable outcome. While PSMA PET imaging is highly accurate in locating cancer sites within the body, its ability to predict treatment response has not yet been thoroughly studied in a prospective manner for this patient population.\n\nThis study will assess the predictive role of PSMA PET imaging and its ability to forecast treatment response across a range of systemic therapies, including hormone therapy and chemotherapy, in patients with both hormone-sensitive (HSPC) and castration-resistant (CRPC) prostate cancer.', 'detailedDescription': 'Purpose: to determine the prognostic value of PSMA PET imaging in patients diagnosed with advanced prostate cancer who are undergoing systemic therapies. The study will enroll patients with either hormone-sensitive (HSPC) or castration-resistant (CRPC) disease.\n\nDesign of the register: observational, pharmacological, non-profit, prospective, multicentric.\n\nDuration of the record: The expected duration for the collection of PET/CT-PSMA examinations is 9 years.\n\nThe primary objective is to evaluate the predictive capacity of PSMA PET, focusing on quantitative parameters such as the number of lesions, tumor volume (as assessed by metabolic tumor volume - MTV), maximum standardized uptake value (SUVmax), and mean standardized uptake value (SUVmean), to stratify patient risk and predict unfavorable clinical outcomes (e.g., progression-free survival, overall survival).\n\nThis research will address the existing knowledge gap regarding the predictive ability of PSMA PET beyond its established role in disease localization. Specifically, the study will investigate if PSMA PET parameters can forecast response to a spectrum of systemic treatments, including but not limited to: abiraterone, enzalutamide, apalutamide, darolutamide, docetaxel, cabazitaxel, olaparib, radiotherapy, 177-lutetium PSMA, and 225-actinium PSMA.\n\nSecondary objectives include:\n\n* Identifying PSMA PET-derived biomarkers that predict response to the aforementioned systemic therapies.\n* Assessing the incremental prognostic and predictive value of PSMA PET in conjunction with standard imaging modalities, namely CT, MRI, and bone scan, in patients undergoing multiple imaging assessments.\n* Evaluating the correlation between changes in PSMA PET-derived tumor volume during treatment and clinical outcomes.\n\nThis study will leverage quantitative imaging data obtained from PSMA PET to develop predictive models that may refine patient stratification and personalize treatment strategies for advanced prostate cancer.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will enroll male patients aged 18 years or older with a histologically confirmed diagnosis of advanced prostate cancer (excluding neuroendocrine carcinoma).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological diagnosis of advanced prostate cancer (excluding neuroendocrine carcinoma);\n* Patients undergoing PSMA PET for pre-treatment disease staging;\n* Candidates to receive one or more of the following systemic therapies, in combination or alone: abiraterone, enzalutamide, apalutamide, darolutamide, docetaxel, cabazitaxel, olaparib, radiotherapy, lutetium-177-PSMA, actinium-225-PSMA;\n* Provision of signed informed consent for study participation and data handling.\n\nExclusion Criteria:\n\n* Inability to remain supine and still for the PET/CT image acquisition;\n* Prostate cancer with a known significant neuroendocrine component;\n* Presence of another concurrent malignancy, with the exception of non-melanoma skin cancer.'}, 'identificationModule': {'nctId': 'NCT07089550', 'acronym': 'PELICAN', 'briefTitle': 'PSMA PET for Treatment Response evaLuation of systemIC Therapies in prostAte caNcer (PELICAN)', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}, 'officialTitle': 'PSMA PET for Treatment Response evaLuation of systemIC Therapies in prostAte caNcer (PELICAN), an Italian Multicenter Study', 'orgStudyIdInfo': {'id': '737/2024/Oss/AOUBO'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PELICAN population', 'description': 'Patients with either hormone-sensitive (HSPC) or castration-resistant (CRPC) prostate cancer', 'interventionNames': ['Radiation: PSMA PET/CT scan']}], 'interventions': [{'name': 'PSMA PET/CT scan', 'type': 'RADIATION', 'description': 'All Patients undergoing PSMA PET for pre-treatment disease staging with different radiotracers (\\[68Ga\\]Ga-PSMA-11, \\[18F\\]-DCFPyL, \\[18F\\]-PSMA-1007).', 'armGroupLabels': ['PELICAN population']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40138', 'city': 'Bologna', 'state': 'Italy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Andrea Farolfi, MD', 'role': 'CONTACT', 'email': 'andrea.farolfi@aosp.bo.it', 'phone': '+390512143959'}, {'name': 'Andrea Farolfi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Andrea Di Giorgio, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Nuclear Medicine, IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '12100', 'city': 'Cuneo', 'state': 'Italy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Virgini Liberini, MD', 'role': 'CONTACT', 'email': 'v.liberini@gmail.com', 'phone': '+390171641111'}, {'name': 'Virgini Liberini, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliera Santa Croce e Carle - ospedale Santa Croce', 'geoPoint': {'lat': 44.39071, 'lon': 7.54828}}, {'zip': '16131', 'city': 'Genova', 'state': 'Italy', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Matteo Bauckneht, MD', 'role': 'CONTACT', 'phone': '+39010555 4812'}, {'role': 'CONTACT', 'email': 'matteo.bauckneht@gmail.com'}, {'name': 'Matteo Bauckneht, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'U.O. Medicina Nucleare, IRCCS Ospedale Policlinico San Martino', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'zip': '98125', 'city': 'Messina', 'state': 'Italy', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Riccardo Laudicella, MD', 'role': 'CONTACT', 'email': 'riccardo.laudicella@unime.it', 'phone': '+390902212841'}, {'name': 'Riccardo Laudicella, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UOC Medicina Nucleare, AOU Policlinico G.Martino', 'geoPoint': {'lat': 38.19394, 'lon': 15.55256}}], 'centralContacts': [{'name': 'Andrea Farolfi, MD', 'role': 'CONTACT', 'email': 'andrea.farolfi@aosp.bo.it', 'phone': '+390512143959'}, {'name': 'Andrea Di Giorgio, MD', 'role': 'CONTACT', 'email': 'andrea.digiorgio@live.it', 'phone': '+390512143959'}], 'overallOfficials': [{'name': 'Andrea Farolfi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ospedale Policlinico San Martino', 'class': 'OTHER'}, {'name': 'Ospedale Santa Croce-Carle Cuneo', 'class': 'OTHER'}, {'name': 'Azienda Ospedaliera Universitaria Policlinico "G. Martino"', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Andrea Farolfi', 'investigatorAffiliation': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}}}}