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

Обзор

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.

Первичные конечные точки

• Overall survival (OS) [Срок оценки: from the start date of the chosen treatment to the date of the subject's death from any cause, up to 3 years]

Вторичные конечные точки (6)

• Cancer-specific survival [Срок оценки: from the start date of the chosen treatment to the subject's death caused by the malignancy, up to 3 years.]
• CRPCa development [Срок оценки: From the date of randomization up to 3 years]
• Radiological progression-free survival [Срок оценки: From the treatment start date to radiological progression, up to 3 years]
• Quality of life assessment [Срок оценки: From admission to discharge, assessed up to 3 years]
• Quality of life assessment [Срок оценки: From admission to discharge, assessed up to 3 years]
• Complications [Срок оценки: From admission to discharge, assessed up to 3 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 12 центров

• Ospedale di Bressanone — Brixen
• Casa di Cura Abano Terme — Abano Terme
• Ospedale di Dolo — Dolo
• Ospedale di Bassano Del Grappa — Bassano del Grappa
• Ospedale dell'Angelo - Mestre — Mestre
• Istituto Oncologico Veneto IRCCS — Padova
• Azienda Ospedale Università Padova — Padova
• Ospedale MAter Salutis - Legnago — Padova
• … и ещё 4 центра

Идентификаторы

NCT: NCT06273345 · IOV-PR-1-2022-OLIGOS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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