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

NCT06273345 | Recruiting

• 1 other identifier: IOV-PR-1-2022-OLIGOS
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 12

Brief Summary

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.

Conditions

Oligometastatic Prostate Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Cancer-specific survival

  from the start date of the chosen treatment to the subject's death caused by the malignancy, up to 3 years.

• CRPCa development

  From the date of randomization up to 3 years

• Radiological progression-free survival

  From the treatment start date to radiological progression, up to 3 years

• Quality of life assessment

  From admission to discharge, assessed up to 3 years

• Quality of life assessment

  From admission to discharge, assessed up to 3 years

Study Arms (1)

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Istituto Oncologico Veneto IRCCS: lead

Study Sites (12)

Ospedale di Bressanone

Brixen, Bolzano, Italy

NOT YET RECRUITING

Casa di Cura Abano Terme

Abano Terme, Padova, Italy

RECRUITING

Ospedale di Dolo

Dolo, Venezia, Italy

RECRUITING

Ospedale di Bassano Del Grappa

Bassano del Grappa, Vicenza, Italy

RECRUITING

Ospedale dell'Angelo - Mestre

Mestre, Italy

RECRUITING

Istituto Oncologico Veneto IRCCS

Padua, 35128, Italy

RECRUITING

Azienda Ospedale Università Padova

Padua, Italy

NOT YET RECRUITING

Ospedale MAter Salutis - Legnago

Padua, Italy

NOT YET RECRUITING

Ospedali Riuniti Padova Sud

Padua, Italy

RECRUITING

Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)

Trieste, Italy

NOT YET RECRUITING

Presidio Ospedaliero Universitario Santa Maria della Misericorida (ASU FC)

Udine, Italy

NOT YET RECRUITING

Azienda Ospedaliera Universitaria Integrata - Verona

Verona, Italy

RECRUITING

Central Study Contacts

Angelo Porreca, MD

CONTACT

0423 421321; angelo.porreca@iov.veneto.it

Gian Luca De Salvo, MD

CONTACT

049 8215710; gianluca.desalvo@iov.veneto.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 22, 2024
• Study Start: January 23, 2023
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (12)