Impact of treatment on prostate cancer with limited metastasis
OLIGOS: Impact of Treatment on Primary Tumour in Patients With Newly Diagnosed Oligometastatic Neoplasia of the Prostate
This study is testing how well local treatments like surgery or radiation, combined with hormone therapy, can help men with early-stage prostate cancer that has spread a little, and how these treatments affect their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Istituto Oncologico Veneto IRCCS Academic / other |
| Locations | 12 sites (Brixen, Bolzano and 11 other locations) |
| Trial ID | NCT06273345 on ClinicalTrials.gov |
What this trial studies
This multicentre prospective observational study aims to create a registry of patients with newly diagnosed oligometastatic prostate carcinoma, following CHAARTED criteria. It will evaluate the oncological outcomes and quality of life impacts of local treatment (surgery or radiotherapy) combined with systemic hormonal therapy. The study focuses on patients with low-volume metastatic disease, ensuring they do not have high metastatic volume characteristics. Data will be collected from major urological centers in the Triveneto region.
Who should consider this trial
Good fit: Ideal candidates are patients with newly diagnosed oligometastatic prostate carcinoma who meet specific low-volume metastatic criteria.
Not a fit: Patients with high-volume metastatic disease or those with poor performance status may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the effectiveness of local treatments combined with systemic therapy for patients with oligometastatic prostate cancer.
How similar studies have performed: Other studies have shown promising results with similar approaches in treating oligometastatic prostate cancer, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Brixen, Bolzano and 11 other locations
- 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 — Padova, Italy (Recruiting)
- Azienda Ospedale Università Padova — Padova, Italy (Not_yet_recruiting)
- Ospedale MAter Salutis - Legnago — Padova, Italy (Not_yet_recruiting)
- Ospedali Riuniti Padova Sud — Padova, 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)
Study contacts
- Study coordinator: Angelo Porreca, MD
- Email: angelo.porreca@iov.veneto.it
- Phone: 0423 421321
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.