protocolSection identificationModule nctId: NCT06273345, orgStudyIdInfo id: IOV-PR-1-2022-OLIGOS, briefTitle: OLIGOS: Impact of Treatment on Primary Tumour in Patients With Newly Diagnosed Oligometastatic Neoplasia of the Prostate, acronym: OLIGOS, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-23, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Istituto Oncologico Veneto IRCCS, class: OTHER, descriptionModule briefSummary: The proposed study consists of a multicentre prospective observational study involving patients with oligometastatic prostatic neoplasia defined according to CHAARTED criteria.The aim of the study is the creation of a registry including patients with newly diagnosed OMPCa, belonging to the main urological centres in the Triveneto region, in order to evaluate the oncological outcomes and the impact on the quality of life of local treatment of the primary neoplasm (surgical or radiotherapy) in addition to systemic hormonal treatment (ADT as monotherapy or in combination with Docetaxel/androgen receptor signal inhibitors (ARTA)).The above criteria define 'high metastatic volume' disease with the following parameters* ≥ 4 bone metastases, including at least one outside the spine and pelvis* Presence of visceral metastases Consequently, patients included in the study should not have the above-mentioned characteristics., conditionsModule conditions: Oligometastatic Prostate Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Cancer-specific survival, secondaryOutcomes measure: CRPCa development, secondaryOutcomes measure: Radiological progression-free survival, secondaryOutcomes measure: Quality of life assessment, secondaryOutcomes measure: Quality of life assessment, secondaryOutcomes measure: Complications, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ospedale di Bressanone, status: NOT_YET_RECRUITING, city: Bressanone, state: Bolzano, country: Italy, contacts name: Michael Aigner, MD, role: CONTACT, email: michael.aigner@sabes.it, contacts name: Michael Aigner, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.71503, lon: 11.65598, locations facility: Casa di Cura Abano Terme, status: RECRUITING, city: Abano Terme, state: Padova, country: Italy, contacts name: Daniele Romagnoli, MD, role: CONTACT, email: dromagnolo@casacura.it, contacts name: Daniele Romagnoli, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.35753, lon: 11.78725, locations facility: Ospedale di Dolo, status: RECRUITING, city: Dolo, state: Venezia, country: Italy, contacts name: Gianna Pace, MD, role: CONTACT, email: gianna.pace@aulss3.veneto.it, contacts name: Gianna Pace, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.42528, lon: 12.08429, locations facility: Ospedale di Bassano Del Grappa, status: RECRUITING, city: Bassano Del Grappa, state: Vicenza, country: Italy, contacts name: Antonio Celia, MD, role: CONTACT, email: antonio.celia@aulss7.veneto.it, contacts name: Antonio Celia, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.76656, lon: 11.72739, locations facility: Ospedale dell'Angelo - Mestre, status: RECRUITING, city: Mestre, country: Italy, contacts name: Francesco Gerardo Mandato, MD, role: CONTACT, email: francesco.mandato@aulss3.veneto.it, contacts name: Francesco Gerardo Mandato, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.49167, lon: 12.24538, locations facility: Istituto Oncologico Veneto IRCCS, status: RECRUITING, city: Padova, zip: 35128, country: Italy, contacts name: Angelo Porreca, MD, role: CONTACT, phone: 0423 421321, phoneExt: +39, email: angelo.porreca@iov.veneto.it, contacts name: Gian Luca De Salvo, MD, role: CONTACT, phone: 049 8215710, phoneExt: +39, email: gianluca.desalvo@iov.veneto.it, contacts name: Angelo Porreca, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.40797, lon: 11.88586, locations facility: Azienda Ospedale Università Padova, status: NOT_YET_RECRUITING, city: Padova, country: Italy, contacts name: Fabio Zattoni, MD, role: CONTACT, email: fabio.zattoni@unipd.it, contacts name: Fabio Zattoni, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.40797, lon: 11.88586, locations facility: Ospedale MAter Salutis - Legnago, status: NOT_YET_RECRUITING, city: Padova, country: Italy, contacts name: Pierpaolo Curti, MD, role: CONTACT, phone: 0442 622387, phoneExt: +39, email: pierpaolo.curti@aulss9.veneto.it, contacts name: Pierpaolo Curti, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.40797, lon: 11.88586, locations facility: Ospedali Riuniti Padova Sud, status: RECRUITING, city: Padova, country: Italy, contacts name: Nicola Zanovello, MD, role: CONTACT, email: nicola.zanovello@aulss6.veneto.it, contacts name: Nicola Zanovello, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.40797, lon: 11.88586, locations facility: Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI), status: NOT_YET_RECRUITING, city: Trieste, country: Italy, contacts name: Carlo Trombetta, MD, role: CONTACT, email: trombcar@units.it, contacts name: Carlo Trombetta, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.64953, lon: 13.77679, locations facility: Presidio Ospedaliero Universitario Santa Maria della Misericorida (ASU FC), status: NOT_YET_RECRUITING, city: Udine, country: Italy, contacts name: Gianluca Giannarini, MD, role: CONTACT, email: gianluca.giannarini@asufc.sanita.fvg.it, contacts name: Gianluca Giannarini, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.0693, lon: 13.23715, locations facility: Azienda Ospedaliera Universitaria Integrata - Verona, status: RECRUITING, city: Verona, country: Italy, contacts name: Alessandro Antonelli, MD, role: CONTACT, phone: 0458127702/03, phoneExt: +39, email: alessandro.antonelli@aovr.veneto.it, contacts name: Alessandro Antonelli, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.4299, lon: 10.98444, hasResults: False