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.
Study Type
OBSERVATIONAL
Enrollment
150
Ospedale di Bressanone
Brixen, Bolzano, Italy
NOT_YET_RECRUITINGCasa di Cura Abano Terme
Abano Terme, Padova, Italy
RECRUITINGOspedale di Dolo
Dolo, Venezia, Italy
RECRUITINGOspedale di Bassano Del Grappa
Bassano del Grappa, Vicenza, Italy
RECRUITINGOspedale dell'Angelo - Mestre
Mestre, Italy
RECRUITINGIstituto Oncologico Veneto IRCCS
Padua, Italy
RECRUITINGAzienda Ospedale Università Padova
Padua, Italy
NOT_YET_RECRUITINGOspedale MAter Salutis - Legnago
Padua, Italy
NOT_YET_RECRUITINGOspedali Riuniti Padova Sud
Padua, Italy
RECRUITINGAzienda Sanitaria Universitaria Giuliano Isontina (ASU GI)
Trieste, Italy
NOT_YET_RECRUITING...and 2 more locations
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.
Time frame: from the start date of the chosen treatment to the date of the subject's death from any cause, up to 3 years
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.
Time frame: from the start date of the chosen treatment to the subject's death caused by the malignancy, up to 3 years.
CRPCa development
Serum testosterone levels \< 50 ng/dL or 1.7 nmol/L in association with biochemical progression or radiological progression
Time frame: From the date of randomization up to 3 years
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).
Time frame: From the treatment start date to radiological progression, up to 3 years
Quality of life assessment
Assessment of QoL using the EuroQol 5-dimensional 5-level questionnaire (EQ-5D-5L)19
Time frame: From admission to discharge, assessed up to 3 years
Quality of life assessment
Assessment of QoL using the EPIC-26 Short Form questionnaire.
Time frame: From admission to discharge, assessed up to 3 years
Complications
Evaluation of complications related to radiotherapy treatment, according to CTCAE v5.0 and surgical treatment, evaluated according to the Clavien Dindo classification
Time frame: From admission to discharge, assessed up to 3 years
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