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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorIstituto Oncologico Veneto IRCCS

About this trial

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 criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

150 Participants
are grouped into 1 trial group