NCT07686016Recruiting
Prostate Radiotherapy and Metastasis-Directed Therapy in Synchronous Oligometastatic Prostate Cancer
Outcomes and Patterns of Failure After Definitive Prostate-Directed Radiotherapy and Metastasis-Directed Therapy in Patients With Synchronous De Novo Prostate Cancer and Up to 10 Metastases: An Ambispective Multicenter Real-World Evidence Registry
Source: ClinicalTrials.gov · Last updated 6 Jul 2026
Brief summary (registry, in English)
This is an ambispective, multicenter, observational real-world registry of patients with synchronous de novo oligometastatic prostate cancer, defined as prostate cancer with up to 10 extraregional metastatic lesions diagnosed at initial presentation or within 6 months of the primary diagnosis. The study will evaluate outcomes after comprehensive local and metastasis-directed treatment. Eligible patients receive definitive prostate-directed radiotherapy, which may include external-beam radiotherapy, external-beam radiotherapy with brachytherapy boost, or definitive prostate brachytherapy monotherapy in selected patients, together with stereotactic body radiotherapy to all identified extraregional metastatic lesions. Systemic therapy is given according to routine clinical practice and local multidisciplinary decisions. The registry is non-interventional. Participants are not assigned to treatment by the study protocol, and no experimental treatment, randomization, or protocol-mandated imaging schedule is used. The study collects de-identified data from routine medical records, including baseline disease characteristics, imaging, radiotherapy details, systemic therapy, radiographic progression, patterns of failure, subsequent treatments, adverse events, and survival. The study includes historical retrospective data, prospective follow-up of previously treated eligible patients, and prospective enrollment of newly eligible patients from the registry activation date. The main goal is to describe where and when prostate cancer progresses after comprehensive treatment of the prostate and all visible metastatic lesions, and to identify clinical and treatment-related factors associated with disease control and adverse events.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 700 (estimated)
- First submitted
- 28 Jun 2026
- Start date
- 26 Jun 2026
- Primary completion date
- 30 Dec 2028
- Lead sponsor
- Affidea Nu-med Center of Oncological DIagnostics and Therapy
- Diseases
- Prostate cancer
- NCT number
- NCT07686016
What you commit to
- Study type: Observational
- Planned participants: 700
- From 26 Jun 2026 to the primary completion date, 30 Dec 2028
- 1 site 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
- Incomplete metastasis-directed therapy, defined as treatment of selected metastatic lesions only while leaving other known baseline extraregional metastatic sites untreated.
- Prostate-directed radiotherapy delivered with palliative rather than definitive intent.
- Missing key dates preventing outcome determination, including prostate-directed radiotherapy, brachytherapy, metastasis-directed SBRT dates, or follow-up information.
- Prior definitive treatment of prostate cancer before diagnosis of synchronous metastatic disease.
Other
- More than 10 extraregional metastatic lesions at baseline staging.
- Histology other than adenocarcinoma of the prostate.
Who the study is looking for
- Histologically confirmed adenocarcinoma of the prostate.
- Male sex.
- Age 18 years or older.
- Synchronous de novo metastatic prostate cancer diagnosed at initial presentation or within 6 months of primary prostate cancer diagnosis.
- Up to 10 extraregional metastatic lesions on staging imaging used for clinical decision-making.
- Treatment with definitive prostate-directed radiotherapy, including external-beam radiotherapy alone, external-beam radiotherapy with brachytherapy boost, or definitive prostate brachytherapy monotherapy in selected patients.
- Treatment with SBRT or another ablative metastasis-directed radiotherapy approach to all identified extraregional metastatic lesions.
- Availability of sufficient clinical, imaging, radiotherapy, systemic therapy, follow-up, adverse event, and survival data for outcome assessment.
- For prospectively enrolled patients, ability to provide informed consent where required by local ethics and regulatory procedures.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Affidea NU-MED Center of Oncological Diagnostics and Therapy Coordinator of this site? Confirm its status | Zamość | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.