OLIGOS: Impact of Treatment on Primary Tumour in Patients With Newly Diagnosed Oligometastatic Neoplasia of the Prostate
NCT ID: NCT06273345
Last Updated: 2025-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
150 participants
OBSERVATIONAL
2023-01-23
2026-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Single arm
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Histological confirmation of disease by prostate biopsies. Absence of neuroendocrine differentiation
* Low volume of metastatic disease defined according to CHAARTED study criteria (\< of 4 bone metastases, absence of visceral metastases)
* Patients without previous treatment of primary malignancy (e.g. previous radical prostatectomy, previous RT)
* Patients treated with systemic therapy (ADT as monotherapy or in combination) for less than 6 months prior to enrolment
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Patients eligible for local treatment of primary malignancy and concomitant systemic therapy
* Signature of informed consent
Exclusion Criteria
* High volume metastatic disease defined according to CHARTEED criteria
* ECOG performance status \> 1
* Patients included in other clinical trials
* Contraindications to hormone/systemic therapy administration
* Previous treatment of primary tumour (RP, RT or other treatment of primary tumour)
18 Years
MALE
No
Sponsors
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Istituto Oncologico Veneto IRCCS
OTHER
Responsible Party
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Locations
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Ospedale di Bressanone
Brixen, Bolzano, Italy
Casa di Cura Abano Terme
Abano Terme, Padova, Italy
Ospedale di Dolo
Dolo, Venezia, Italy
Ospedale di Bassano Del Grappa
Bassano del Grappa, Vicenza, Italy
Ospedale dell'Angelo - Mestre
Mestre, , Italy
Istituto Oncologico Veneto IRCCS
Padua, , Italy
Azienda Ospedale Università Padova
Padua, , Italy
Ospedale MAter Salutis - Legnago
Padua, , Italy
Ospedali Riuniti Padova Sud
Padua, , Italy
Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)
Trieste, , Italy
Presidio Ospedaliero Universitario Santa Maria della Misericorida (ASU FC)
Udine, , Italy
Azienda Ospedaliera Universitaria Integrata - Verona
Verona, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IOV-PR-1-2022-OLIGOS
Identifier Type: -
Identifier Source: org_study_id
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