Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2025-12-29 @ 10:28 PM
Study NCT ID:
NCT02460861
Status:
UNKNOWN
Last Update Posted:
2015-06-03
First Post:
2015-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraoperational Prostate Loge Biopsies (iPROLOGX) After Radical Prostatovesiculectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D000072662', 'term': 'Margins of Excision'}], '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'}, {'id': 'D065308', 'term': 'Morphological and Microscopic Findings'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 279}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-05-29', 'studyFirstSubmitDate': '2015-05-28', 'studyFirstSubmitQcDate': '2015-05-29', 'lastUpdatePostDateStruct': {'date': '2015-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Methylation status of GSTP1', 'timeFrame': '2 years', 'description': 'Methylation status of GSTP1 is analysed by quantitative methylation-specific PCR (Q-MSP)'}, {'measure': 'Histopathology of prostate fossa biopsies', 'timeFrame': '2 years', 'description': 'Histopathology of prostate fossa biopsies (Prostata cancer positive or negative)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prostate Cancer', 'Molecular staging', 'GSTP1', 'Surgical margins', 'prostatovesiculectomy'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This project is about the detection of occult tumor cells in surgical margins of radical prostatovesiculectomy by analysing the methylation status of Glutathione S-transferase P 1 (GSTP1). After gland excision specimens are obtained from 9 defined areas of the prostatic fossa. The biopsies are divided into two parts. One part used for histopathological analysis and the other part for moleculargenetic analysis. Results will be correlated e.g. with tumor stage, Gleason Score and prostate specific antigen (PSA).\n\nThe prostate-cancer-negative control group with bladder cancer.', 'detailedDescription': "This project is about the detection of occult tumor cells in surgical margins of radical prostatovesiculectomy by analysing the methylation status of Glutathione S-transferase P 1 (GSTP1). After gland excision specimens are obtained from 9 defined areas of the prostatic fossa. The biopsies are divided into two parts. One part used for histopathological analysis and the other part for moleculargenetic analysis. Results will be correlated e.g. with tumor stage, Gleason Score and prostate specific antigen (PSA).\n\nThe prostate-cancer-negative control group with bladder cancer.\n\nDNA ISOLATION\n\nDNA from biopsies stored by -80°C was isolated by using innuPREP DNA mini Kit (Analytik Jena, Jena, Germany) following protocol 1 of the manufacturer's instructions. DNA was eluted with 50 µl elution buffer. Concentration and purity were analysed by using Nanodrop 2000.\n\nDNA BISULFITE MODIFICATION\n\nDNA was modified by using EpiTect Bisulfite Kit (QIAGEN, Hilden, Germany) according to manufacturer's instructions. Samples were eluted once with 20 µl elution buffer.\n\nQUANTITATIVE METHYLATION SPECIFIC PCR\n\nMethylation status of GSTP1 is analysed by quantitative methylation-specific PCR (Q-MSP) using StepOnePlus Real-Time PCR System and StepOne Software v2.1 from Applied Biosystems (Darmstadt, Germany). Q-MSP was performed in duplicate analysing genes Actin and GSTP1. The primers' and testing probes' sequences used to amplify and detect hypermethylated GSTP1 were: 5'-AgTTgCgCggCgATTTC (forward primer), 5'-gCCCCAATACTAAATCACgACg (reverse primer) and 5'-CggTCgACgTTCggggTgTAgCg (taqman probe), labelled with fluorescence dye FAM. The primers' and testing probes' sequences used to amplify and detect Actin were: 5'-TggTgATggAggAggTTTAgTAAgT (forward primer), 5'-AACCAATAAAACCTACTCCTCCCTTAA (reverse primer),5'-ACCACCACCCAACACACAATAACAAACACA (taqman probe), labelled with fluorescence dye VIC.\n\nThe Q-MSP was carried out at 50°C for 2 min., 95°C for 15 min. followed by 50 cycles of 95°C for 1s and 60°C for 1 min. As a positive control bisulfite-converted DNA of DU145 and LNCap were used. Blank reactions with destillated water, which replaced DNA, served as negative control (NTC)."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Criteria for patients with prostate adenocarcinoma:\n\nInclusion Criteria\n\n* sex: male\n* diagnosis: prostate adenocarcinoma\n* treatment: radical prostatovesiculectomy\n* period of treatment: 11/30/2011 - 10/15/2013\n\nExclusion Criteria\n\n* sex: female\n* diagnosis: no prostate adenocarcinoma\n* treatment: no radical prostatovesiculectomy\n* period of treament: before 11/30/2011 or after 10/15/2013\n\nCriteria for prostate adenocarcinoma negative control group:\n\nInclusion Criteria\n\n* sex: male\n* diagnosis: urothelial carcinoma\n* treatment: cysto-prostatectomy\n* period of treament: 12/14/2011 - 02/18/2014\n\nExclusion Criteria\n\n* sex: female\n* diagnosis: incidental prostate adenocarcinoma\n* treatment: no cysto-prostatectomy\n* period of treatment: before 12/14/2011 or after 02/18/2014'}, 'identificationModule': {'nctId': 'NCT02460861', 'acronym': 'iPROLOGX', 'briefTitle': 'Intraoperational Prostate Loge Biopsies (iPROLOGX) After Radical Prostatovesiculectomy', 'organization': {'class': 'OTHER', 'fullName': 'University of Magdeburg'}, 'officialTitle': 'Intraoperational Prostate Loge Biopsies (iPROLOGX) After Radical Prostatovesiculectomy (RPVE) in Prostate Cancer (PCA) Patients for Molecular Tumor Marker Analysis', 'orgStudyIdInfo': {'id': 'MD-URO-00021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PCA Magdeburg', 'description': 'Prostate cancer conducted for RPVE with curative Intention, biopsies of the prostatic fossa in Magdeburg', 'interventionNames': ['Procedure: biopsies of the prostatic fossa in Magdeburg', 'Procedure: RPVE']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-prostate cancer Magdeburg/Gronau', 'description': 'Conducted for CE in Male with bladder cancer or other indication for cystectomy but without prostate cancer in Magdeburg or Gronau, biopsies of the prostatic fossa in Gronau', 'interventionNames': ['Procedure: biopsies of the prostatic fossa in Magdeburg', 'Procedure: CE', 'Procedure: biopsies of the prostatic fossa in gronau']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PCA Gronau', 'description': 'Prostate cancer conducted for ETRARP with curative Intention, biopsies of the prostatic fossa', 'interventionNames': ['Procedure: ETRARP', 'Procedure: biopsies of the prostatic fossa in gronau']}], 'interventions': [{'name': 'biopsies of the prostatic fossa in Magdeburg', 'type': 'PROCEDURE', 'otherNames': ['surgical biopsies'], 'description': 'intraoperative Open surgical biopsies of the prostatic fossa after prostatevesiculectomy in Magdeburg', 'armGroupLabels': ['Non-prostate cancer Magdeburg/Gronau', 'PCA Magdeburg']}, {'name': 'RPVE', 'type': 'PROCEDURE', 'otherNames': ['surgical prostatectomy'], 'description': 'Open Radical prostatovesiculectomy in Magdeburg', 'armGroupLabels': ['PCA Magdeburg']}, {'name': 'ETRARP', 'type': 'PROCEDURE', 'otherNames': ['surgical prostatectomy'], 'description': 'Robotassisted Radical prostatovesiculectomy in Gronau', 'armGroupLabels': ['PCA Gronau']}, {'name': 'CE', 'type': 'PROCEDURE', 'otherNames': ['surgical cystoprostatectomy'], 'description': 'Open cystectomy in Magdeburg/Gronau', 'armGroupLabels': ['Non-prostate cancer Magdeburg/Gronau']}, {'name': 'biopsies of the prostatic fossa in gronau', 'type': 'PROCEDURE', 'otherNames': ['surgical biopsies'], 'description': 'intraoperative endoscopic robotassisted biopsies of the prostatic fossa after prostatevesiculectomy in Gronau', 'armGroupLabels': ['Non-prostate cancer Magdeburg/Gronau', 'PCA Gronau']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48599', 'city': 'Gronau', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'St. Antonius Hospital', 'geoPoint': {'lat': 52.21099, 'lon': 7.02238}}, {'zip': '39120', 'city': 'Magdeburg', 'state': 'Saxony-Anhalt', 'country': 'Germany', 'facility': 'Department of Urology, University Clinic Otto von Guericke University Magdeburg', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}], 'overallOfficials': [{'name': 'Martin Schostak, Prof.Dr.med.', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Magdeburg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Magdeburg', 'class': 'OTHER'}, 'collaborators': [{'name': 'St. Antonius Hospital Gronau', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. med.', 'investigatorFullName': 'Johann J. Wendler, MD', 'investigatorAffiliation': 'University of Magdeburg'}}}}