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

Recruiting now

Conditions studied: Oligometastatic Prostate Carcinoma

In brief

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.

Key facts

Study ID

NCT06273345

Run by

Istituto Oncologico Veneto IRCCS

People needed

150

Starts

2023-01-23

Expected to finish

2026-01-01

Last updated by the study team

2025-04-17

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Ospedale di Dolo — Dolo, Venezia, Italy (enrolling)
• Ospedali Riuniti Padova Sud — Padova, Italy (enrolling)
• Ospedale di Bassano Del Grappa — Bassano del Grappa, Vicenza, Italy (enrolling)
• Ospedale dell'Angelo - Mestre — Mestre, Italy (enrolling)
• Azienda Ospedaliera Universitaria Integrata - Verona — Verona, Italy (enrolling)
• Istituto Oncologico Veneto IRCCS — Padova, Italy (enrolling)
• Casa di Cura Abano Terme — Abano Terme, Padova, Italy (enrolling)
• Azienda Ospedale Università Padova — Padova, Italy
• Ospedale di Bressanone — Brixen, Bolzano, Italy
• Ospedale MAter Salutis - Legnago — Padova, Italy
• Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) — Trieste, Italy
• Presidio Ospedaliero Universitario Santa Maria della Misericorida (ASU FC) — Udine, Italy

Full record on ClinicalTrials.gov

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