Actively Recruiting
OLIGOS: Impact of Treatment on Primary Tumour in Patients With Newly Diagnosed Oligometastatic Neoplasia of the Prostate
Led by Istituto Oncologico Veneto IRCCS · Updated on 2025-04-17
150
Participants Needed
12
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
OLIGOS: Impact of Treatment on Primary Tumour in Patients With Newly Diagnosed Oligometastatic Neoplasia of the Prostate
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of new-onset prostate neoplasia (any risk category according to EAU guidelines)
- Histological confirmation by prostate biopsies without neuroendocrine differentiation
- Low volume metastatic disease with fewer than 4 bone metastases and no visceral metastases per CHAARTED criteria
- No previous treatment of primary malignancy (e.g., radical prostatectomy or radiotherapy)
- Systemic therapy (ADT alone or combined) for less than 6 months before enrollment
- ECOG performance status 0-1
- Eligible for local treatment of primary tumor and systemic therapy
- Signed informed consent
You will not qualify if you...
- Unable or unwilling to give written informed consent
- High volume metastatic disease per CHAARTED criteria
- ECOG performance status greater than 1
- Participation in other clinical trials
- Contraindications to hormone or systemic therapy
- Previous treatment of primary tumor (surgery, radiotherapy, or other)
AI-Screening
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Trial Site Locations
Total: 12 locations
1
Ospedale di Bressanone
Brixen, Bolzano, Italy
Not Yet Recruiting
2
Casa di Cura Abano Terme
Abano Terme, Padova, Italy
Actively Recruiting
3
Ospedale di Dolo
Dolo, Venezia, Italy
Actively Recruiting
4
Ospedale di Bassano Del Grappa
Bassano del Grappa, Vicenza, Italy
Actively Recruiting
5
Ospedale dell'Angelo - Mestre
Mestre, Italy
Actively Recruiting
6
Istituto Oncologico Veneto IRCCS
Padova, Italy, 35128
Actively Recruiting
7
Azienda Ospedale Università Padova
Padova, Italy
Not Yet Recruiting
8
Ospedale MAter Salutis - Legnago
Padova, Italy
Not Yet Recruiting
9
Ospedali Riuniti Padova Sud
Padova, Italy
Actively Recruiting
10
Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)
Trieste, Italy
Not Yet Recruiting
11
Presidio Ospedaliero Universitario Santa Maria della Misericorida (ASU FC)
Udine, Italy
Not Yet Recruiting
12
Azienda Ospedaliera Universitaria Integrata - Verona
Verona, Italy
Actively Recruiting
Research Team
A
Angelo Porreca, MD
CONTACT
G
Gian Luca De Salvo, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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