NCT06273345 OLIGOS: Impact of Treatment on Primary Tumour in Patients With Newly Diagnosed Oligometastatic Neoplasia of the Prostate
| NCT ID | NCT06273345 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Oncologico Veneto IRCCS |
| Condition | Oligometastatic Prostate Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2023-01-23 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2023-01-23 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06273345 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Oligometastatic Prostate Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06273345 currently recruiting?
Yes, NCT06273345 is actively recruiting participants. Contact the research team at angelo.porreca@iov.veneto.it for enrollment information.
Where is the NCT06273345 trial being conducted?
This trial is being conducted at Brixen, Italy, Abano Terme, Italy, Dolo, Italy, Bassano del Grappa, Italy and 8 additional locations.
Who is sponsoring the NCT06273345 clinical trial?
NCT06273345 is sponsored by Istituto Oncologico Veneto IRCCS. The trial plans to enroll 150 participants.