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

Recruiting

• Conditions: Oligometastatic Prostate Carcinoma

• Registration Number: NCT06273345
• Lead Sponsor: Istituto Oncologico Veneto IRCCS

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-23
• Study First Submitted: 2024-02-06
• Study First Submitted QC: 2024-02-15
• Study First Posted: 2024-02-22
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-17
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 150

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	from the start date of the chosen treatment to the date of the subject's death from any cause, up to 3 years	Impact of primary tumour treatment in addition to systemic therapy on overall survival (OS) in patients with new-onset oligometastatic prostate neoplasia.

Secondary Outcome Measures

Name	Time	Method
Cancer-specific survival	from the start date of the chosen treatment to the subject's death caused by the malignancy, up to 3 years.	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.
Radiological progression-free survival	From the treatment start date to radiological progression, up to 3 years	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).
CRPCa development	From the date of randomization up to 3 years	Serum testosterone levels \< 50 ng/dL or 1.7 nmol/L in association with biochemical progression or radiological progression
Quality of life assessment	From admission to discharge, assessed up to 3 years	Assessment of QoL using the EPIC-26 Short Form questionnaire.
Complications	From admission to discharge, assessed up to 3 years	Evaluation of complications related to radiotherapy treatment, according to CTCAE v5.0 and surgical treatment, evaluated according to the Clavien Dindo classification

Trial Locations

Locations (12)

Istituto Oncologico Veneto IRCCS; 🇮🇹 Padova, Italy

Ospedali Riuniti Padova Sud; 🇮🇹 Padova, Italy

Ospedale di Bressanone; 🇮🇹 Bressanone, Bolzano, Italy

Ospedale di Dolo; 🇮🇹 Dolo, Venezia, Italy

Casa di Cura Abano Terme; 🇮🇹 Abano Terme, Padova, Italy

Ospedale di Bassano Del Grappa; 🇮🇹 Bassano Del Grappa, Vicenza, Italy

Ospedale dell'Angelo - Mestre; 🇮🇹 Mestre, Italy

Azienda Ospedale Università Padova; 🇮🇹 Padova, Italy

Ospedale MAter Salutis - Legnago; 🇮🇹 Padova, Italy

Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI); 🇮🇹 Trieste, Italy

Presidio Ospedaliero Universitario Santa Maria della Misericorida (ASU FC); 🇮🇹 Udine, Italy

Azienda Ospedaliera Universitaria Integrata - Verona; 🇮🇹 Verona, Italy