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.
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)
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
Patients with a diagnosis of new-onset oligo-metastatic prostatic neoplasia are included in the study. The definition of oligo-metastatic neoplasm is based on the CHARTEED criteria (less than 4 metastases, absence of visceral metastases). All patients should undergo staging by conventional imaging techniques (total body bone scintigraphy, CT abdomen with mdc) or with PET-CT (choline or PSMA) and multiparametric prostate MRI to assess the local extension (clinical stage) of the disease, surgical resectability of the disease and radiotherapy planning. In addition, individual cases should be discussed in the multidisciplinary oncology group of the enrolling centre. The choice of treatment type will be based on the decision of the multidisciplinary team and the patient's preferences.
Cohort
Prospective
Not listed
Overall survival (OS)
Impact of primary tumour treatment in addition to systemic therapy on overall survival (OS) in patients with new-onset oligometastatic prostate neoplasia.
Cancer-specific survival
CSS is defined as the time (quantified in months) from the start date of the chosen treatment and the subject's death caused by the malignancy.
CRPCa development
Serum testosterone levels \< 50 ng/dL or 1.7 nmol/L in association with biochemical progression or radiological progression
Radiological progression-free survival
Definition of radiological progression (r-PFS): time from treatment start date to radiological progression (appearance of two or more new lesions on bone scintigraphy or appearance of visceral lesions).
Quality of life assessment
Assessment of QoL using the EuroQol 5-dimensional 5-level questionnaire (EQ-5D-5L)19
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