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
- Diseases
- Prostate cancer
- 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
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Casa di Cura Abano Terme Coordinator of this site? Confirm its status | Abano Terme | Italy | Recruiting |
| Ospedale di Bassano Del Grappa Coordinator of this site? Confirm its status | Bassano del Grappa | Italy | Recruiting |
| Ospedale di Bressanone Coordinator of this site? Confirm its status | Brixen | Italy | Not yet recruiting |
| Ospedale di Dolo Coordinator of this site? Confirm its status | Dolo | Italy | Recruiting |
| Ospedale dell'Angelo - Mestre Coordinator of this site? Confirm its status | Mestre | Italy | Recruiting |
| Azienda Ospedale Universita Padova Coordinator of this site? Confirm its status | Padova | Italy | Not yet recruiting |
| Istituto Oncologico Veneto - IRCCS Coordinator of this site? Confirm its status | Padova | Italy | Recruiting |
| Ospedali Riuniti Padova Sud Coordinator of this site? Confirm its status | Padova | Italy | Recruiting |
| Ospedale MAter Salutis - Legnago Coordinator of this site? Confirm its status | Padova | Italy | Not yet recruiting |
| Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) Coordinator of this site? Confirm its status | Trieste | Italy | Not yet recruiting |
| Presidio Ospedaliero Universitario Santa Maria della Misericorida (ASU FC) Coordinator of this site? Confirm its status | Udine | Italy | Not yet recruiting |
| Azienda Ospedaliera Universitaria Integrata Verona Coordinator of this site? Confirm its status | Verona | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.