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

Recruitingn/aAges 18 Years - anyMaleIstituto Oncologico Veneto IRCCS
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In plain words

What the trial is, and whether it could suit you

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 th

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📋 Eligibility rules (as published)
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)
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What it tests

  • Not listed
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Where

12 sites
Ospedale di Bressanone
Brixen, Italy
Casa di Cura Abano Terme
Abano Terme, Italy
Ospedale di Dolo
Dolo, Italy
Ospedale di Bassano Del Grappa
Bassano del Grappa, Italy
Ospedale dell'Angelo - Mestre
Mestre, Italy
Istituto Oncologico Veneto IRCCS
Padova, Italy
Azienda Ospedale Università Padova
Padova, Italy
Ospedale MAter Salutis - Legnago
Padova, Italy

…and 4 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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