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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | from the start date of the chosen treatment to the date of the subject's death from any cause, up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | from the start date of the chosen treatment to the subject's death caused by the malignancy, up to 3 years. |
| CRPCa development |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Angelo Porreca, MD | Contact | 0423 421321 | +39 | angelo.porreca@iov.veneto.it |
| Gian Luca De Salvo, MD | Contact | 049 8215710 | +39 | gianluca.desalvo@iov.veneto.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale di Bressanone | Not yet recruiting | Brixen | Bolzano | Italy |
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Serum testosterone levels < 50 ng/dL or 1.7 nmol/L in association with biochemical progression or radiological progression |
| 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). | 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 | From admission to discharge, assessed up to 3 years |
| Quality of life assessment | Assessment of QoL using the EPIC-26 Short Form questionnaire. | 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 | From admission to discharge, assessed up to 3 years |
| Casa di Cura Abano Terme | Recruiting | Abano Terme | Padova | Italy |
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| Ospedale di Dolo | Recruiting | Dolo | Venezia | Italy |
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| Ospedale di Bassano Del Grappa | Recruiting | Bassano del Grappa | Vicenza | Italy |
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| Ospedale dell'Angelo - Mestre | Recruiting | Mestre | Italy |
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| Istituto Oncologico Veneto IRCCS | Recruiting | Padova | 35128 | Italy |
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| Azienda Ospedale Università Padova | Not yet recruiting | Padova | Italy |
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| Ospedale MAter Salutis - Legnago | Not yet recruiting | Padova | Italy |
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| Ospedali Riuniti Padova Sud | Recruiting | Padova | Italy |
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| Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) | Not yet recruiting | Trieste | Italy |
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| Presidio Ospedaliero Universitario Santa Maria della Misericorida (ASU FC) | Not yet recruiting | Udine | Italy |
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| Azienda Ospedaliera Universitaria Integrata - Verona | Recruiting | Verona | Italy |
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