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NCT06273345Recruiting

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

Source: ClinicalTrials.gov · Last updated 17 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
150 (estimated)
First submitted
6 Feb 2024
Start date
23 Jan 2023
Primary completion date
Jan 2026
Lead sponsor
Istituto Oncologico Veneto IRCCS
NCT number
NCT06273345

What you commit to

  • Study type: Observational
  • Planned participants: 150
  • From 23 Jan 2023 to the primary completion date, Jan 2026
  • 12 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Contraindications to hormone/systemic therapy administration
  • Previous treatment of primary tumour (RP, RT or other treatment of primary tumour)

Other illness

  • High volume metastatic disease defined according to CHARTEED criteria

Other

  • Inability or unwillingness to give written informed consent
  • ECOG performance status \> 1
  • Patients included in other clinical trials

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: Male

Full criteria on ClinicalTrials.gov

Sites (12)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Casa di Cura Abano Terme
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Abano TermeItalyRecruiting
Ospedale di Bassano Del Grappa
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Bassano del GrappaItalyRecruiting
Ospedale di Bressanone
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BrixenItalyNot yet recruiting
Ospedale di Dolo
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DoloItalyRecruiting
Ospedale dell'Angelo - Mestre
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MestreItalyRecruiting
Azienda Ospedale Universita Padova
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PadovaItalyNot yet recruiting
Istituto Oncologico Veneto - IRCCS
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PadovaItalyRecruiting
Ospedali Riuniti Padova Sud
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PadovaItalyRecruiting
Ospedale MAter Salutis - Legnago
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PadovaItalyNot yet recruiting
Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)
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TriesteItalyNot yet recruiting
Presidio Ospedaliero Universitario Santa Maria della Misericorida (ASU FC)
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UdineItalyNot yet recruiting
Azienda Ospedaliera Universitaria Integrata Verona
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VeronaItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.