Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-01-02 @ 9:54 AM
Study NCT ID:
NCT01530269
Status:
COMPLETED
Last Update Posted:
2019-03-07
First Post:
2012-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
C11-Sodium Acetate PET/CT Imaging for Metastatic Disease in Intermediate-to-high Risk Prostate Adenocarcinoma
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': 'C000615233', 'term': 'Carbon-11'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-05', 'studyFirstSubmitDate': '2012-02-04', 'studyFirstSubmitQcDate': '2012-02-07', 'lastUpdatePostDateStruct': {'date': '2019-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tissue Biopsy of metastatic site(s)', 'timeFrame': 'Assessed within 30 days following AC-PET', 'description': 'Patients will undergo needle biopsy of positive metastatic findings on C11- Acetate PET/CT'}], 'secondaryOutcomes': [{'measure': 'PSA (prostate specific antigen)', 'timeFrame': 'Each 3 - 6 months for 24 months', 'description': 'PSA (prostate specific antigen) will be monitored per routine clinical follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['intermediate', 'high', 'risk', 'radiation', 'therapy', 'planning', 'surgical', 'immunotherapy', 'chemotherapy', 'hormone'], 'conditions': ['Prostate Cancer', 'Prostate Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'Positron emission tomography using carbon-11 acetate (AC-PET) may help find local or distant metastases from prostate cancer. This clinical trial is studying how this imaging test may help influence the choice and extent of initial treatments, and subsequent treatments.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the role of positron emission tomography using carbon-11 acetate (AC-PET) in the initial and subsequent management of patients with prostate cancer at intermediate or high risk for recurrence after initial curative therapy.\n* Compare the value of AC-PET in predicting recurrence of prostate cancer with that of conventional approaches (e.g., pre-operative clinical staging, prostate-specific antigen, Gleason score, prostate and lymph node histology) in these patients.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMale patients will be studied who have prostate cancer:\n\n* Diagnosed with prostate adenocarcinoma\n* Has completed conventional staging examinations, including histologic evaluation with Gleason score, CT scan of the abdomen and pelvis, and whole-body bone scintigraphy Candidate for curative prostatectomy OR curative radiotherapy OR staging lymphadenectomy prior to surgery\n* Deemed to be at intermediate or high risk for recurrence or metastatic disease after initial curative treatment, as defined by of one of the following:\n\n * Gleason score \\>= 7 or PSA \\>= 10\n * Gleason score \\< 7 or PSA \\<10 ng/mL with positive surgical margins, biopsy proven or suspected regional nodal involvement or conventional imaging showing limited metastatic disease that may be amenable to directed radiotherapy\n * Rising or non-responding PSA\n\nExclusion Criteria:\n\n* \\< 18 years old\n* claustrophobic patients'}, 'identificationModule': {'nctId': 'NCT01530269', 'briefTitle': 'C11-Sodium Acetate PET/CT Imaging for Metastatic Disease in Intermediate-to-high Risk Prostate Adenocarcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Phoenix Molecular Imaging'}, 'officialTitle': 'C11-Sodium Acetate PET/CT Imaging for Metastatic Disease in Intermediate-to-high Risk Prostate Adenocarcinoma', 'orgStudyIdInfo': {'id': 'AMIC-AC-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PET/CT imaging with C11-Sodium Acetate', 'interventionNames': ['Drug: C11-Sodium Acetate']}], 'interventions': [{'name': 'C11-Sodium Acetate', 'type': 'DRUG', 'otherNames': ['C11 Acetate PET', 'Carbon 11', 'AC-PET'], 'description': 'PET Imaging with C11-Sodium Acetate', 'armGroupLabels': ['PET/CT imaging with C11-Sodium Acetate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85040', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Phoenix Molecular Imaging', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}], 'overallOfficials': [{'name': 'Fabio Almeida, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical Director, Phoenix Molecular Imaging'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Phoenix Molecular Imaging', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Director and Principal Investigator', 'investigatorFullName': 'Fabio Almeida MD', 'investigatorAffiliation': 'Phoenix Molecular Imaging'}}}}