Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
Study NCT ID:
NCT00121212
Status:
COMPLETED
Last Update Posted:
2015-10-30
First Post:
2005-07-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Positron Emission Tomography 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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 179}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-28', 'studyFirstSubmitDate': '2005-07-19', 'studyFirstSubmitQcDate': '2005-07-19', 'lastUpdatePostDateStruct': {'date': '2015-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the role of AC-PET in changing initial patient management', 'timeFrame': 'Completion of patient treatment'}], 'secondaryOutcomes': [{'measure': 'Determine the value of AC-PET in predicting recurrence', 'timeFrame': 'Minimum of 2 years and maximum of 5 years'}, {'measure': 'Assess the performance of AC-PET for detection of lymph node metastasis by comparison with biopsy.', 'timeFrame': 'Minimum of 2 years and maximum of 5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stage I prostate cancer', 'stage IIB prostate cancer', 'stage IIA prostate cancer', 'stage III prostate cancer'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Diagnostic procedures, such as positron emission tomography using carbon-11 acetate, may help find metastases from prostate cancer and may help predict whether prostate cancer will come back after treatment.\n\nPURPOSE: This clinical trial is studying how well positron emission tomography using carbon-11 acetate works in finding metastases and predicting recurrence in patients with prostate cancer who are at risk for recurrence after treatment.', 'detailedDescription': 'The overall goal of this project is determination of the role of PET in patients with newly diagnosed medium- and high-risk prostate cancer in whom the standard clinical and imaging workup is negative. Thus, the incremental value of PET will be determined in this important group.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Newly diagnosed prostate cancer\n* Has completed conventional staging examinations, including biopsy with Gleason score, CT scan of the abdomen and pelvis, and whole-body bone scintigraphy AND conventional staging examinations negative\n* Candidate for curative radical prostatectomy OR curative radiotherapy OR staging lymphadenectomy prior to surgery\n* Deemed to be at medium or high risk for recurrence after initial curative treatment, as defined by 1 of the following criteria:\n\n * Gleason score 7 AND prostate-specific antigen (PSA) 10-20 ng/mL\n * Gleason score ≥ 8 AND PSA \\< 10 ng/mL\n * Gleason score ≥ 8 AND PSA \\> 10 ng/mL\n * Any Gleason score AND PSA \\> 20 ng/mL\n\nExclusion Therapy:\n\n* Not a candidate for treatment by surgery or radiation therapy with curative intent\n* Inability to give informed consent\n* Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of other cancer present within the last 5 years'}, 'identificationModule': {'nctId': 'NCT00121212', 'briefTitle': 'Positron Emission Tomography in Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Positron Emission Tomography in Prostate Cancer', 'orgStudyIdInfo': {'id': 'CDR0000434994'}, 'secondaryIdInfos': [{'id': 'R01CA101734', 'link': 'https://reporter.nih.gov/quickSearch/R01CA101734', 'type': 'NIH'}, {'id': 'P30CA091842', 'link': 'https://reporter.nih.gov/quickSearch/P30CA091842', 'type': 'NIH'}, {'id': 'WU-03-0315'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Surgery - Negative PET scan', 'description': "If patient is candidate for surgery with curative intent or staging lymphadenectomy, he will be enrolled in the study. If patient's PET scan is negative, the patient will receive the curative therapy and be followed for recurrence.", 'interventionNames': ['Procedure: carbon-11 acetate PET scan']}, {'type': 'EXPERIMENTAL', 'label': 'Surgery - Positive PET scan', 'description': "If patient is candidate for surgery with curative intent or staging lymphadenectomy, he will be enrolled in the study. If patient's PET scan is positive, the patient will receive the curative therapy and be followed for recurrence or receive alternative therapy.", 'interventionNames': ['Procedure: carbon-11 acetate PET scan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Radiation therapy Negative or Positive PET scan', 'description': 'If patient is candidate for radiation therapy with curative intent, he will be enrolled. If PET scan is negative he will receive curative therapy and be followed for PSA recurrence. If PET scan is positive he may receive confirmatory studies and then if negative, not indicated, or refused he will receive curative therapy be followed for PSA recurrence. If PET scan is positive and received positive confirmatory studies he will receive curative therapy and followed for recurrence.', 'interventionNames': ['Procedure: carbon-11 acetate PET scan']}], 'interventions': [{'name': 'carbon-11 acetate PET scan', 'type': 'PROCEDURE', 'armGroupLabels': ['Radiation therapy Negative or Positive PET scan', 'Surgery - Negative PET scan', 'Surgery - Positive PET scan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Farrokh Dehdashti, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Washington University Siteman Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}