Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2026-02-25 @ 6:43 PM
Study NCT ID:
NCT02362620
Status:
UNKNOWN
Last Update Posted:
2020-01-27
First Post:
2015-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PROSTAC: Prospective Multi-centre Study of Prognostic Factors in mCRPC Patients Treated With Docetaxel or Cabazitaxel.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood and FFPE tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 402}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-23', 'studyFirstSubmitDate': '2015-02-09', 'studyFirstSubmitQcDate': '2015-02-12', 'lastUpdatePostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To validate the prognostic value of the gene-expression signature from peripheral blood described by Olmos et al (Lancet Oncol 2012) on overall survival of mCRPC patients', 'timeFrame': '48 months'}], 'secondaryOutcomes': [{'measure': 'To analyze the prognostic value of the gene-expression signature described by Olmos et al on biochemical and radiological progression-free survival', 'timeFrame': '48 months'}, {'measure': 'To analyze the prognostic value of early changes in the gene-expression signature described by Olmos et al', 'timeFrame': '48 months'}, {'measure': 'To compare the prognostic value of the gene-expression signature described by Olmos et al versus the gene-expression signature described by Ross et al (Lancet Oncol, 2012)', 'timeFrame': '48 months'}, {'measure': 'To validate the prognostic value of classical nomograms designed to assess the outcomes of mCRPC patients in these both cohorts of patients', 'timeFrame': '48 months'}, {'measure': 'To analyze the prognostic value of TMPRSS2-ERG rearrengement and PTEN loss in these cohorts', 'timeFrame': '48 months'}, {'measure': 'To analyze the prognostic value of AR splicing variants, serum chromogranine and serum testosterone levels measured by ultrasensitive method in these both cohorts of patients', 'timeFrame': '48 months'}, {'measure': 'To correlate the presence of somatic and/or germinal mutations with the outcomes of these patients', 'timeFrame': '48 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['metastatic Castration Resistant Prostate Cancer', 'Taxanes', 'Biomarkers'], 'conditions': ['Advanced Prostate Cancer', 'Cabazitaxel', 'Docetaxel']}, 'descriptionModule': {'briefSummary': 'PROSTAC is a prospective multicentre observational study in metastatic Castration-Resistant Prostate Cancer (mCRPC), designed to explore prognostic biomarkers in patients undergoing treatment with docetaxel or cabazitaxel', 'detailedDescription': 'This study is a prospective biomarker study of patients with mCRPC undergoing treatment with docetaxel or cabazitaxel as standard of care treatment. The participants will undergo serial pre- and post-therapy blood collection for biomarker analysis as part of the primary objective of the study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Castration-Resistant Prostate Cancer patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male age ≥ 18 years\n2. Histologically confirmed adenocarcinome of the prostate\n3. ECOG Performance Status ≤ 2\n4. Castration resistance must be documented with surgical or medical castration with serum testosterone \\< 50 ng/mL (\\< 2.0 nM).\n5. Men diagnosed with at least one metastatic lesion on CT or bone scan.\n6. Documented biochemical and/or radiographic progression to previous treatment according to PCWG2 criteria.\n7. Patients who are candidates for standard of care treatment with docetaxel 75mg/m2 every 3 weeks or cabazitaxel 20-25mg/m2 every 3 weeks intravenously.\n8. Availability of formalin-fixed paraffin-embedded blocks from the prostate biopsy and/or radical prostatectomy.\n9. Acceptable hematological, hepatic and renal functions.\n\nExclusion Criteria:\n\n1. Previous cancer diagnosis, except those patients who had a localized malignant tumour and who are five years cancer-free or those diagnosed with skin cancers (of non-melanoma type) or excised in situ carcinomas.\n2. Any condition or reason that, in the opinion of the Investigator, interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of safety data'}, 'identificationModule': {'nctId': 'NCT02362620', 'acronym': 'PROSTAC', 'briefTitle': 'PROSTAC: Prospective Multi-centre Study of Prognostic Factors in mCRPC Patients Treated With Docetaxel or Cabazitaxel.', 'organization': {'class': 'OTHER', 'fullName': 'Centro Nacional de Investigaciones Oncologicas CARLOS III'}, 'officialTitle': 'Prospective Multi-centre Study of Prognostic Factors in Metastatic Castration-Resistant Prostate Cancer Patients Treated With Docetaxel or Cabazitaxel.', 'orgStudyIdInfo': {'id': 'CNI-DOC-2014-02'}, 'secondaryIdInfos': [{'id': 'CNIO-CP-02-2014', 'type': 'OTHER', 'domain': 'CNIO'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Docetaxel', 'description': 'Docetaxel 75mg/m2 IV every 3 weeks'}, {'label': 'Cabazitaxel', 'description': 'Cabazitaxel 20-25mg/m2 IV every 3 weeks'}]}, 'contactsLocationsModule': {'locations': [{'zip': '15706', 'city': 'Santiago de Compostela', 'state': 'A Coruña', 'country': 'Spain', 'facility': 'Hospital Universitario de Santiago', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'zip': '08907', 'city': "L'Hospitalet de Llobregat", 'state': 'Barcelona', 'country': 'Spain', 'facility': "ICO L'Hospitalet", 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}, {'zip': '08243', 'city': 'Manresa', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Althaia Manresa', 'geoPoint': {'lat': 41.72815, 'lon': 1.82399}}, {'zip': '11407', 'city': 'Jerez de la Frontera', 'state': 'Cádiz', 'country': 'Spain', 'facility': 'Hospital de Especialidades de Jerez de la Frontera', 'geoPoint': {'lat': 36.68645, 'lon': -6.13606}}, {'zip': '29603', 'city': 'Marbella', 'state': 'Málaga', 'country': 'Spain', 'facility': 'Hospital Costa del Sol', 'geoPoint': {'lat': 36.51543, 'lon': -4.88583}}, {'zip': '31008', 'city': 'Pamplona', 'state': 'Navarre', 'country': 'Spain', 'facility': 'Complejo Hospitalario de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': '38320', 'city': 'San Cristóbal de La Laguna', 'state': 'Tenerife', 'country': 'Spain', 'facility': 'Hospital Universitario de Canarias', 'geoPoint': {'lat': 28.4853, 'lon': -16.32014}}, {'zip': '15009', 'city': 'A Coruña', 'country': 'Spain', 'facility': 'Fundacion Centro Oncologico de Galicia', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Universitario Vall D'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '13005', 'city': 'Ciudad Real', 'country': 'Spain', 'facility': 'Hospital de Ciudad Real', 'geoPoint': {'lat': 38.98626, 'lon': -3.92907}}, {'zip': '14004', 'city': 'Córdoba', 'country': 'Spain', 'facility': 'Hospital Universitario Reina Sofia', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'zip': '18014', 'city': 'Granada', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen de las Nieves', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'zip': '19002', 'city': 'Guadalajara', 'country': 'Spain', 'facility': 'Hospital Universitario de Guadalajara', 'geoPoint': {'lat': 40.62862, 'lon': -3.16185}}, {'zip': '28007', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Gregorio Maranon', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28029', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Coordination PROCURE-Centro Nacional de Investigaciones Oncologicas', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Clinico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28050', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Centro Integral Oncológico Clara Campal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '29010', 'city': 'Málaga', 'country': 'Spain', 'facility': 'Anatomical Pathology PROCURE', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '29010', 'city': 'Málaga', 'country': 'Spain', 'facility': 'Hospital Regional Universitario Virgen de la Victoria', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '29010', 'city': 'Málaga', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen de la Victoria', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '30008', 'city': 'Murcia', 'country': 'Spain', 'facility': 'Hospital Morales Messeguer', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}, {'zip': '07120', 'city': 'Palma de Mallorca', 'country': 'Spain', 'facility': 'Hospital Son Espases', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'zip': '36002', 'city': 'Pontevedra', 'country': 'Spain', 'facility': 'Complejo Hospitalario de Pontevedra', 'geoPoint': {'lat': 42.431, 'lon': -8.64435}}, {'zip': '46026', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Universitario La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'David Olmos, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Head of Prostate Cancer Clinical Research Unit CNIO'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro Nacional de Investigaciones Oncologicas CARLOS III', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}