NCT06273345

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Istituto Oncologico Veneto IRCCS · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Oligometastatic Prostate Carcinoma

Timeline

• Start date: 2023-01-23
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2024-02-22
• Last updated: 2025-04-17

Locations

12 sites across 1 country: Italy