Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2026-02-23 @ 9:21 PM
Study NCT ID:
NCT00977457
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-19
First Post:
2009-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genetic Testing in Predicting Biomarkers of Recurrence in Patients With Prostate Cancer Undergoing Surgery
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': 'D019175', 'term': 'DNA Methylation'}, {'id': 'D020869', 'term': 'Gene Expression Profiling'}, {'id': 'D016133', 'term': 'Polymerase Chain Reaction'}], 'ancestors': [{'id': 'D008745', 'term': 'Methylation'}, {'id': 'D000478', 'term': 'Alkylation'}, {'id': 'D001669', 'term': 'Biochemical Phenomena'}, {'id': 'D055598', 'term': 'Chemical Phenomena'}, {'id': 'D008660', 'term': 'Metabolism'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D021141', 'term': 'Nucleic Acid Amplification Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1045}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2007-11-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-07-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-18', 'studyFirstSubmitDate': '2009-09-12', 'studyFirstSubmitQcDate': '2009-09-12', 'lastUpdatePostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Performance of these models in predicting the likelihood of BCR', 'timeFrame': 'Visit 2 (intraoperative setting)', 'description': 'Logistic regression and artificial neural networks will be used.'}], 'secondaryOutcomes': [{'measure': 'Comparison of the performance in these models in predicting upgrading and upstaging prior to surgery', 'timeFrame': 'Visit 2 (intraoperative setting)', 'description': 'Logistic regression and artificial neural networks will be used.'}, {'measure': 'Comparison of the performance of these models in improving risk stratification among patients eligible for active surveillance', 'timeFrame': 'Visit 2 (intraoperative setting)', 'description': 'Logistic regression and artificial neural networks will be used.'}, {'measure': 'Determination whether prostatic massage or surgery raises the count of circulating tumor cells (CTCs) in post-DRE blood specimens', 'timeFrame': 'Visit 2 (intraoperative setting)', 'description': 'Logistic regression and artificial neural networks will be used.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage I prostate cancer', 'stage II prostate cancer', 'stage III prostate cancer', 'stage IV prostate cancer'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': "This trial studies the side effects and best way to perform genetic testing in predicting biomarkers of recurrence in patients with prostate cancer undergoing surgery. Collecting and storing samples of tissue, blood, and other body fluids from patients to test in the laboratory and collecting information about the patient's health and treatment may help doctors learn more about cancer and help predict the recurrence of prostate cancer", 'detailedDescription': 'PRIMARY OBJECTIVES: I. To explore the performance of these models in predicting the likelihood of biochemical recurrence (BCR).\n\nSECONDARY OBJECTIVES: I. To explore the performance of these models in predicting upgrading and upstaging prior to surgery. II. To explore the performance of these models in improving risk stratification among patients eligible for active surveillance. III. To determine whether prostatic massage or surgery raises the count of circulating tumor cells (CTC) in post-digital rectal exam (DRE) blood specimens.\n\nOUTLINE: Patients receive prostatic massage and undergo a digital rectal exam (DRE). Laboratory assessments are performed and blood samples are collected for molecular biology testing. On the day of the scheduled prostatectomy, a second blood collection is performed prior to surgery.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- All men undergoing robotic prostatectomy or cystoprostatectomy at City of Hope will be eligible for the study\n\nExclusion Criteria:\n\n\\- Men who undergo neoadjuvant treatment with Androgen Deprivation Therapy (ADT) or salvage prostatectomy including those who have had brachytherapy will be excluded'}, 'identificationModule': {'nctId': 'NCT00977457', 'briefTitle': 'Genetic Testing in Predicting Biomarkers of Recurrence in Patients With Prostate Cancer Undergoing Surgery', 'organization': {'class': 'OTHER', 'fullName': 'City of Hope Medical Center'}, 'officialTitle': 'Pre-Surgical EPS Biomarkers as Predictors of Biochemical Recurrence', 'orgStudyIdInfo': {'id': '06072'}, 'secondaryIdInfos': [{'id': 'P30CA033572', 'link': 'https://reporter.nih.gov/quickSearch/P30CA033572', 'type': 'NIH'}, {'id': 'CHNMC-06072'}, {'id': 'CDR0000644208', 'type': 'REGISTRY', 'domain': 'NCI PDQ'}, {'id': '5R01CA102521', 'link': 'https://reporter.nih.gov/quickSearch/5R01CA102521', 'type': 'NIH'}, {'id': 'NCI-2011-00980', 'type': 'REGISTRY', 'domain': 'NCI CTRP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diagnostic (specimen collection)', 'description': 'Patients receive prostatic massage and undergo a digital rectal examination. Laboratory assessments are performed and blood samples are collected for molecular biology testing. On the day of the scheduled prostatectomy, a second blood collection is performed prior to surgery.', 'interventionNames': ['Genetic: DNA analysis', 'Genetic: DNA methylation analysis', 'Genetic: RNA analysis', 'Genetic: gene expression analysis', 'Genetic: polymerase chain reaction', 'Other: diagnostic laboratory biomarker analysis', 'Procedure: therapeutic conventional surgery']}], 'interventions': [{'name': 'DNA analysis', 'type': 'GENETIC', 'description': 'Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery', 'armGroupLabels': ['Diagnostic (specimen collection)']}, {'name': 'DNA methylation analysis', 'type': 'GENETIC', 'description': 'Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery', 'armGroupLabels': ['Diagnostic (specimen collection)']}, {'name': 'RNA analysis', 'type': 'GENETIC', 'description': 'Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery', 'armGroupLabels': ['Diagnostic (specimen collection)']}, {'name': 'gene expression analysis', 'type': 'GENETIC', 'description': 'Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery', 'armGroupLabels': ['Diagnostic (specimen collection)']}, {'name': 'polymerase chain reaction', 'type': 'GENETIC', 'description': 'Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery', 'armGroupLabels': ['Diagnostic (specimen collection)']}, {'name': 'diagnostic laboratory biomarker analysis', 'type': 'OTHER', 'description': 'Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery', 'armGroupLabels': ['Diagnostic (specimen collection)']}, {'name': 'therapeutic conventional surgery', 'type': 'PROCEDURE', 'otherNames': ['Undergo robotic prostatectomy or cystoprostatectomy'], 'armGroupLabels': ['Diagnostic (specimen collection)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010-3000', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}], 'overallOfficials': [{'name': 'Steven S. Smith, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'City of Hope Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'City of Hope Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}