Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-01-05 @ 5:20 PM
Study NCT ID:
NCT01516866
Status:
COMPLETED
Last Update Posted:
2019-11-18
First Post:
2011-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sodium Fluoride (NaF) Positron Emission Tomography/Computed Tomography (PET/CT) in Patients With Metastatic Castrate-resistant Prostate Cancer (CRPC) With Microtubule Directed Chemo or AR-directed Therapy
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': 'D012969', 'term': 'Sodium Fluoride'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}, {'id': 'D014965', 'term': 'X-Rays'}], 'ancestors': [{'id': 'D005459', 'term': 'Fluorides'}, {'id': 'D006858', 'term': 'Hydrofluoric Acid'}, {'id': 'D017611', 'term': 'Fluorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D002327', 'term': 'Cariostatic Agents'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D011839', 'term': 'Radiation, Ionizing'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-14', 'studyFirstSubmitDate': '2011-11-28', 'studyFirstSubmitQcDate': '2012-01-19', 'lastUpdatePostDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The repeatability of NaF PET/CT imaging for evaluating bone metastases in patients with metastatic castrate-resistant prostate cancer.', 'timeFrame': '2 years', 'description': 'NaF PET/CT scan will be performed within 14 days prior to starting chemotherapy (antimicrotubule directed chemotherapy) or hormone-directed therapy (baseline #1). A portion of subjects (up to 20 subjects at each site, 60 subjects total) will have a second NaF PET/CT scan performed (baseline #2) within 1-8 days of the initial scan to see if measurements repeated over a short period of time are similar.'}], 'secondaryOutcomes': [{'measure': 'Evaluate changes on NaF PET/CT images in response to chemotherapy (antimicrotubule directed chemotherapy) or androgen receptor (AR)-directed therapy.', 'timeFrame': '2 years', 'description': 'All subjects will undergo NaF PET/CT scanning at baseline and again either 8 weeks after starting treatment with antimicrotubule chemotherapy based treatment (Cohort A) OR at both 6 weeks and 12 weeks after starting AR-directed treatment (Cohort B).'}, {'measure': 'Prostate Specific Antigen (PSA) response', 'timeFrame': '2 years', 'description': 'Results from the NaF PET/CT scans will be compared with PSA and bone scan and CT scan results.'}, {'measure': 'Response Evaluation Criteria in Solid Tumors (RECIST) response', 'timeFrame': '2 years'}, {'measure': 'Radiographic progression free survival', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Androgen receptor-directed therapy', 'NaF PET/CT', 'antimicrotubule directed chemotherapy'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://cancer.wisc.edu/', 'label': 'University of Wisconsin Carbone Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to evaluate a newer imaging technique, called 18F-Sodium Fluoride (NaF) positron emission tomography (PET). NaF is a tracer (dye) that is very sensitive for changes in bone. By using this tracer with positron emission tomography/computed tomography (PET/CT) imaging, our ability to evaluate and measure changes in bone lesions could be greatly improved.', 'detailedDescription': 'The study will look at how repeatable the NaF PET scans are before treatment. Scans will also be performed after standard chemotherapy or hormone-directed treatment. This will allow evaluation of how the NaF PET scans change with the chemotherapy or hormone-directed therapy. In addition, NaF PET scans will be compared with standard computed tomography (CT) and bone scans, as well as prostate specific antigen (PSA). This information could be used to develop better ways to measure prostate cancer bone lesions. In turn, this could be used to better evaluate treatment effects of standard chemotherapy and other new drugs being developed to treat prostate cancer.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary care clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed adenocarcinoma of the prostate\n* Identifiable prostate cancer-related bone metastases on bone scan in the spine, pelvis or other bone\n* Patients must be starting a microtubule directed chemotherapy regimen for metastatic castrate-resistant prostate cancer OR\n* Patients must be starting a AR-directed regimen (e.g. Abiraterone, MDV-3100, TAK-700, etc) for treatment of metastatic castrate-resistant prostate\n\nExclusion Criteria:\n\n* Concurrent treatment with any other agent that is being used with the expressed purpose of treating of prostate cancer outside of the planned treatment regimen\n* Patients who have received radiotherapy less than 4 weeks prior to registration.\n* Patients who have received prior Strontium-89, Samarium-153, or other radioisotope.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to sodium fluoride F-18 (NaF).'}, 'identificationModule': {'nctId': 'NCT01516866', 'acronym': 'NaFl PET/CT', 'briefTitle': 'Sodium Fluoride (NaF) Positron Emission Tomography/Computed Tomography (PET/CT) in Patients With Metastatic Castrate-resistant Prostate Cancer (CRPC) With Microtubule Directed Chemo or AR-directed Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'NaF PET/CT Repeatability, Responsiveness, and Response Assessment in Patients With Metastatic Castrate-resistant Prostate Cancer to Bone Treated With Either an Antimicrotubule Directed Agent or Androgen Receptor (AR)-Directed Therapies', 'orgStudyIdInfo': {'id': 'CO11811'}, 'secondaryIdInfos': [{'id': '2011-0397', 'type': 'OTHER', 'domain': 'Institutional Review Board'}, {'id': 'A534260', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'SMPH\\MEDICINE\\HEM-ONC', 'type': 'OTHER', 'domain': 'UW Madison'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort A: Microtubule directed chemotherapy treatment', 'description': 'Subjects receiving antimicrotubule chemotherapy-based treatment will have NaF PET/CT scans at baseline and again after 8 weeks of starting treatment. A subset of subjects will have a second NaF PET/CT scan at baseline 1-8 days after the first baseline scan.', 'interventionNames': ['Procedure: Sodium Fluoride (NaF) Positron Emission Tomography/Computed Tomography (PET/CT) imaging']}, {'label': 'Cohort B: AR-directed therapy', 'description': 'Subjects receiving AR-directed therapy will undergo a baseline NaF PET/CT scan at baseline and again after having been on treatment for 6 weeks and again at 12 weeks. A subset of subjects will also undergo a second baseline NaF PET/CT scan 1-8 days after the first baseline scan.', 'interventionNames': ['Procedure: Sodium Fluoride (NaF) Positron Emission Tomography/Computed Tomography (PET/CT) imaging']}], 'interventions': [{'name': 'Sodium Fluoride (NaF) Positron Emission Tomography/Computed Tomography (PET/CT) imaging', 'type': 'PROCEDURE', 'description': 'Subjects who will be enrolled will be those who will be starting treatment (as part of standard of care or as part of another trial) with either a microtubule directed chemotherapy regimen (cohort A), or AR-directed therapy (cohort B). All subjects will have a baseline NaF PET/CT scan (baseline #1), performed within days prior to starting either chemotherapy or AR-directed therapy. A subset of subjects (up to 20 subjects per site, 60 total) will undergo a second NaF PET/CT scan (baseline #2) within 1-8 days of the initial scan to determine repeatability of NaF PET/CT scanning. Subjects in cohort A will undergo another NaF PET/CT scan at week 8 (+/- 1 week). Subjects in cohort B will undergo two additional NaF PET/CT scans at weeks 6 and 12 (+/- 1 week).', 'armGroupLabels': ['Cohort A: Microtubule directed chemotherapy treatment', 'Cohort B: AR-directed therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Cancer Institute', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Carbone Cancer Center', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Glenn Liu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}, {'name': 'Robert Jeraj, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}