Viewing Study NCT06724159


Ignite Creation Date: 2025-12-24 @ 2:56 PM
Ignite Modification Date: 2026-02-01 @ 9:26 AM
Study NCT ID: NCT06724159
Status: RECRUITING
Last Update Posted: 2025-06-04
First Post: 2024-12-04
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Observational Study of the Effectiveness of Funded Drugs for Genitourinary Tumors.
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D002295', 'term': 'Carcinoma, Transitional Cell'}, {'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000607739', 'term': 'darolutamide'}, {'id': 'C000632577', 'term': 'enfortumab vedotin'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-30', 'studyFirstSubmitDate': '2024-12-04', 'studyFirstSubmitQcDate': '2024-12-04', 'lastUpdatePostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progresion-free survival rate at 18 months', 'timeFrame': '18 months after the initiation of study treatment', 'description': 'For TRIDA substudy. Defined as the percentage of patients alive and free of progression of the disease (estimated by Kaplan-Meier method) at 18 months. Patients without event are censored in their last follow-up'}, {'measure': 'Relapse-free survival rate at 24 months', 'timeFrame': '24 months after the first dose of study treatment', 'description': 'For NIADY substudy. Defined as the percentage of patients alive and with no disease recurrence (estimated by Kaplan-Meier method) at 24 months'}, {'measure': 'Overall survival rate at 12 months', 'timeFrame': '12 months after the first dose of study treatment', 'description': 'For EV3aL substudy Defined as the percentage of patients alive (estimated by Kaplan-Meier method) at 12 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Urothelial carcinoma', 'Prostate adenocarcinoma', 'Renal carcinoma', 'Darolutamida', 'Nivolumab', 'Enfortumab Vedotin'], 'conditions': ['Genitourinary Cancers']}, 'descriptionModule': {'briefSummary': 'SOGUG-PRINCIS is a retrospective (regarding patient inclusion) and prospective follow-up, epidemiological, non-interventional, non-blinded, non-randomized, multicenter, national observational study with drugs. This study will collect data from patients with genitourinary tumors to analyze the effectiveness under routine clinical practice conditions of drugs recently approved for funding in the Spanish National Health System.\n\nIn all cases, the decision to start treatment will be made prior to and independently of participation in the study, which will be limited to subsequently collecting the data necessary to assess the objectives of the study.\n\nThis study will serve as a registry for genitourinary cancers. Every time a new drug will be authorized, a new subproject with a primary endpoint will be opened to recruitment. The substudy will try to validate with real-world data the endpoints reported in the phase III clinical trials that led to the marketin authorization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with genitourinary cancers treated with new therapies following the standard clinical practice', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥18 years old.\n* Patients granting the ICF unless exemption or exceptions mentioned below.\n* Histological diagnosis of malignant neoplasia originating in the genitourinary system: kidney, renal pelvis, ureter, bladder, prostate, testicle and germinal tissue of other locations, urethra, penis, or seminal vesicles.\n* Patients have started treatment with medications whose positive resolution of financing by the Spanish National Health System for the aforementioned tumors has been after January 1, 2023.\n* Patients have started treatment after the official publication of the positive resolution of financing of the drug under study by the National Health System. This restriction is intended to avoid interference of the study with the marketing authorization processes by the European Medicines Agency, and price and reimbursement negotiations by the Spanish health authorities.\n* Patients have received treatment at the participating center.\n\nExclusion Criteria:\n\n* Patients previously treated at another centre who have subsequently been referred to one of the participating centres. In this case, the patient will be included in the centre where treatment was started, or in the second centre if the first is not part of this study.\n* Patients who do not meet any of the inclusion criteria.\n* Evidence of an express objection by the subject or his/her legal representative to participate in the study.'}, 'identificationModule': {'nctId': 'NCT06724159', 'acronym': 'SOGUG-PRINCIS', 'briefTitle': 'Observational Study of the Effectiveness of Funded Drugs for Genitourinary Tumors.', 'organization': {'class': 'OTHER', 'fullName': 'Spanish Oncology Genito-Urinary Group'}, 'officialTitle': 'PRINCIS Study ("Public Health Clinical Research Project"): Observational Study of the Effectiveness of Drugs Funded by the National Health System for Genitourinary Tumors.', 'orgStudyIdInfo': {'id': 'SOGUG-PRINCIS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TRIDA Cohort', 'description': 'Patients with hormone-sensitive prostate carcinoma not castrated who have started treatment with darolutamide in combination with androgen deprivation therapy and docetaxel, from January 1, 2024', 'interventionNames': ['Drug: darolutamide']}, {'label': 'NIADY Cohort', 'description': 'Patients with urothelial carcinoma who have started treatment with adjuvant Nivolumab on or after August 1, 2023', 'interventionNames': ['Drug: Nivolumab monotherapy']}, {'label': 'EV3aL Cohort', 'description': 'Patients with urothelial carcinoma who have started treatment with Enfortumab Vedotin (EV) on or after January 1, 2024', 'interventionNames': ['Drug: enfortumab vedotin']}], 'interventions': [{'name': 'darolutamide', 'type': 'DRUG', 'description': 'Darolutamide in combination with androgen deprivation therapy and docetaxel. Following the posology and administration details of its marketing authorization and standard clinical practice', 'armGroupLabels': ['TRIDA Cohort']}, {'name': 'Nivolumab monotherapy', 'type': 'DRUG', 'description': 'Adjuvant nivolumab following after surgical removal of urothelial carcinoma. Following the posology and administration details of its marketing authorization and standard clinical practice', 'armGroupLabels': ['NIADY Cohort']}, {'name': 'enfortumab vedotin', 'type': 'DRUG', 'description': 'Following the posology and administration details of its marketing authorization and standard clinical practice', 'armGroupLabels': ['EV3aL Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04009', 'city': 'Almería', 'state': 'Andalusia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'A responsible person Designated by the Sponsor', 'role': 'CONTACT', 'email': 'investigacion@mfar.net', 'phone': '0034934344412'}, {'name': 'A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Torrecárdenas', 'geoPoint': {'lat': 36.83814, 'lon': -2.45974}}, {'zip': '14004', 'city': 'Córdoba', 'state': 'Andalusia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'A responsible person Designated by the Sponsor', 'role': 'CONTACT', 'email': 'investigacion@mfar.net', 'phone': '0034934344412'}, {'name': 'A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Reina Sofía', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'zip': '18007', 'city': 'Granada', 'state': 'Andalusia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'A responsible person Designated by the Sponsor', 'role': 'CONTACT', 'email': 'investigacion@mfar.net', 'phone': '0034934344412'}, {'name': 'A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Clínico San Cecilio', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'zip': '18014', 'city': 'Granada', 'state': 'Andalusia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'A responsible person Designated by the Sponsor', 'role': 'CONTACT', 'email': 'investigacion@mfar.net', 'phone': '0034934344412'}, {'name': 'A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Virgen a de las Nieves', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'zip': '23007', 'city': 'Jaén', 'state': 'Andalusia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'A responsible person Designated by the Sponsor', 'role': 'CONTACT', 'email': 'investigacion@mfar.net', 'phone': '0034934344412'}, {'name': 'A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario de Jaén', 'geoPoint': {'lat': 37.76922, 'lon': -3.79028}}, {'zip': '11407', 'city': 'Jerez de la Frontera', 'state': 'Andalusia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'A responsible person Designated by the Sponsor', 'role': 'CONTACT', 'email': 'investigacion@mfar.net', 'phone': '0034934344412'}, {'name': 'A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Jerez de la Frontera', 'geoPoint': {'lat': 36.68645, 'lon': -6.13606}}, {'zip': '29010', 'city': 'Málaga', 'state': 'Andalusia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'A responsible person Designated by the Sponsor', 'role': 'CONTACT', 'email': 'investigacion@mfar.net', 'phone': '0034934344412'}, {'name': 'A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Virgen de la Victoria', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '41009', 'city': 'Seville', 'state': 'Andalusia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'A responsible person Designated by the Sponsor', 'role': 'CONTACT', 'email': 'investigacion@mfar.net', 'phone': '0034934344412'}, {'name': 'A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Virgen Macarena', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '41013', 'city': 'Seville', 'state': 'Andalusia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'A responsible person Designated by the Sponsor', 'role': 'CONTACT', 'email': 'investigacion@mfar.net', 'phone': '0034934344412'}, {'name': 'A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Virgen del Rocío', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '41014', 'city': 'Seville', 'state': 'Andalusia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'A responsible person Designated by the Sponsor', 'role': 'CONTACT', 'email': 'investigacion@mfar.net', 'phone': '0034934344412'}, {'name': 'A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Virgen de Valme', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '22004', 'city': 'Huesca', 'state': 'Aragon', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'A responsible person Designated by the Sponsor', 'role': 'CONTACT', 'email': 'investigacion@mfar.net', 'phone': '0034934344412'}, {'name': 'A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario San Jorge', 'geoPoint': {'lat': 42.13615, 'lon': -0.4087}}, {'zip': '50009', 'city': 'Zaragoza', 'state': 'Aragon', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'A responsible person Designated by the Sponsor', 'role': 'CONTACT', 'email': 'investigacion@mfar.net', 'phone': '0034934344412'}, {'name': 'A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Clínico Universitario Lozano Blesa', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}, {'zip': '50009', 'city': 'Zaragoza', 'state': 'Aragon', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'A responsible person Designated by the Sponsor', 'role': 'CONTACT', 'email': 'investigacion@mfar.net', 'phone': '0034934344412'}, {'name': 'A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Miguel Servet', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}, {'zip': '07703', 'city': 'Maó', 'state': 'Balearic Islands', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'A responsible person Designated by the Sponsor', 'role': 'CONTACT', 'email': 'investigacion@mfar.net', 'phone': '0034934344412'}, {'name': 'A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital General Mateu Orfila', 'geoPoint': {'lat': 39.88853, 'lon': 4.26583}}, {'zip': '07120', 'city': 'Palma de Mallorca', 'state': 'Balearic Islands', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'A responsible person Designated by the Sponsor', 'role': 'CONTACT', 'email': 'investigacion@mfar.net', 'phone': '0034934344412'}, {'name': 'A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Son Espases', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'zip': '07198', 'city': 'Palma de Mallorca', 'state': 'Balearic Islands', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'A responsible person Designated by the Sponsor', 'role': 'CONTACT', 'email': 'investigacion@mfar.net', 'phone': '0034934344412'}, {'name': 'A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Son Llàtzer', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'zip': '48903', 'city': 'Barakaldo', 'state': 'Basque Country', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'A responsible person Designated by the Sponsor', 'role': 'CONTACT', 'email': 'investigacion@mfar.net', 'phone': '0034934344412'}, {'name': 'A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario de Cruces', 'geoPoint': {'lat': 43.29639, 'lon': -2.98813}}, {'zip': '48013', 'city': 'Bilbao', 'state': 'Basque Country', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Designated by the Sponsor', 'role': 'CONTACT', 'email': 'investigacion@mfar.net', 'phone': '0034934344412'}, {'name': 'A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Basurto', 'geoPoint': {'lat': 43.26271, 'lon': -2.92528}}, {'zip': '20014', 'city': 'Donostia / San Sebastian', 'state': 'Basque Country', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'A responsible person Designated by the Sponsor', 'role': 'CONTACT', 'email': 'investigacion@mfar.net', 'phone': '0034934344412'}, {'name': 'A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'OSI Donostialdea - Onkologikoa', 'geoPoint': {'lat': 43.31283, 'lon': -1.97499}}, {'zip': '48960', 'city': 'Galdakao', 'state': 'Basque Country', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'A responsible person Designated by the Sponsor', 'role': 'CONTACT', 'email': 'investigacion@mfar.net', 'phone': '0034934344412'}, {'name': 'A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Galdakao-Usansolo Ospitalea', 'geoPoint': {'lat': 43.23073, 'lon': -2.8429}}, {'zip': '01009', 'city': 'Vitoria-Gasteiz', 'state': 'Basque Country', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'A responsible person Designated by the Sponsor', 'role': 'CONTACT', 'email': 'investigacion@mfar.net', 'phone': '0034934344412'}, {'name': 'A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario de Álava - Txagorritxu', 'geoPoint': {'lat': 42.84998, 'lon': -2.67268}}, {'zip': '35016', 'city': 'Las Palmas de Gran Canaria', 'state': 'Canary Islands', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'A responsible person Designated by the Sponsor', 'role': 'CONTACT', 'email': 'investigacion@mfar.net', 'phone': '0034934344412'}, {'name': 'A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Materno Infantil de Gran Canaria', 'geoPoint': {'lat': 28.10178, 'lon': -15.41573}}, {'zip': '09006', 'city': 'Burgos', 'state': 'Castille and León', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'A responsible person Designated by the Sponsor', 'role': 'CONTACT', 'email': 'investigacion@mfar.net', 'phone': '0034934344412'}, {'name': 'A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario de Burgos', 'geoPoint': {'lat': 42.34106, 'lon': -3.70184}}, {'zip': '34004', 'city': 'Palencia', 'state': 'Castille and León', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'A responsible person Designated by the Sponsor', 'role': 'CONTACT', 'email': 'investigacion@mfar.net', 'phone': '0034934344412'}, {'name': 'A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Complejo Hospitalario de Palencia', 'geoPoint': {'lat': 42.00955, 'lon': -4.52406}}, {'zip': '37007', 'city': 'Salamanca', 'state': 'Castille and León', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'A responsible person Designated by the Sponsor', 'role': 'CONTACT', 'email': 'investigacion@mfar.net', 'phone': '0034934344412'}, {'name': 'A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Complejo Asistencial Universitario de Salamanca', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}, {'zip': '40002', 'city': 'Segovia', 'state': 'Castille and León', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'A responsible person Designated by the Sponsor', 'role': 'CONTACT', 'email': 'investigacion@mfar.net', 'phone': '0034934344412'}, {'name': 'A Principal Investigator Designated by the Sponsor, M.D.; 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