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Clinical Trials in Italy / NCT06273345
Recruiting Observational

OLIGOS: Impact of Treatment on Primary Tumour in Patients With Newly Diagnosed Oligometastatic Neoplasia of the Prostate

NCT06273345 · tracked via the Priya Life Science Italy tracker
Sponsor
Istituto Oncologico Veneto IRCCS
Phase
Observational
Started
2023-01-23
Last updated
2025-04-17

Condition(s) studied

Oligometastatic Prostate Carcinoma

Study summary

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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Diagnosis of new-onset prostate neoplasia (any risk category according to EAU guidelines). * 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: * Inability or unwillingness to give written informed consent * 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)

Primary outcome measure(s)

Trial sites (12)

FacilityCityRegionStatus
Ospedale di Bressanone Brixen Bolzano Not Yet Recruiting
Casa di Cura Abano Terme Abano Terme Padova Recruiting
Ospedale di Dolo Dolo Venezia Recruiting
Ospedale di Bassano Del Grappa Bassano del Grappa Vicenza Recruiting
Ospedale dell'Angelo - Mestre Mestre Italy Recruiting
Istituto Oncologico Veneto IRCCS Padova Italy Recruiting
Azienda Ospedale Università Padova Padova Italy Not Yet Recruiting
Ospedale MAter Salutis - Legnago Padova Italy Not Yet Recruiting
Ospedali Riuniti Padova Sud Padova Italy Recruiting
Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) Trieste Italy Not Yet Recruiting
Presidio Ospedaliero Universitario Santa Maria della Misericorida (ASU FC) Udine Italy Not Yet Recruiting
Azienda Ospedaliera Universitaria Integrata - Verona Verona Italy Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06273345 on ClinicalTrials.gov ↗ ← All trials in Italy