OLIGOS: Impact of Treatment on Primary Tumour in Patients With Newly Diagnosed Oligometastatic Neoplasia of the Prostate
Recruiting · NCT06273345 · Observational (researchers observe without assigning treatment) · Lead sponsor: Istituto Oncologico Veneto IRCCS
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
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)
Where it is running
12 locations listed.
- 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
- 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