RecruitingNCT06273345

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


Sponsor

Istituto Oncologico Veneto IRCCS

Enrollment

150 participants

Start Date

Jan 23, 2023

Study Type

OBSERVATIONAL

Conditions

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: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating how systemic treatment (hormone therapy with or without additional drugs) affects the primary prostate tumor in men who have newly diagnosed prostate cancer that has already spread to a small number of sites in the body (called oligometastatic disease). **You may be eligible if...** - You have a new diagnosis of prostate cancer confirmed by biopsy - You have a small number of bone metastases (fewer than 4) and no spread to internal organs - You have not previously received treatment for your prostate cancer - You are in good general health (ECOG performance status 0 or 1) **You may NOT be eligible if...** - You have previously had prostate surgery or radiation - You have been on hormone therapy for more than 6 months - You have extensive cancer spread (visceral metastases or 4 or more bone lesions) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(12)

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

Padova, Italy

Azienda Ospedale Università Padova

Padova, Italy

Ospedale MAter Salutis - Legnago

Padova, Italy

Ospedali Riuniti Padova Sud

Padova, 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

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NCT06273345


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