Prostate Radiotherapy and Metastasis-Directed Therapy in Synchronous Oligometastatic Prostate Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

SynSABR-PC is a multicenter, ambispective observational registry of men with synchronous de novo oligometastatic prostate cancer (up to 10 metastatic lesions) treated with definitive prostate-directed radiotherapy and metastasis-directed SBRT to all visible lesions. Participants are managed according to standard clinical practice, without protocol-mandated treatments or randomization. The study aims to describe treatment patterns, outcomes, and sites of failure in real-world settings across diverse centers. Data collected include imaging, radiotherapy details, systemic therapy, follow-up, adverse events, and survival. This registry seeks to illuminate how comprehensive local and metastasis-directed radiotherapy performs outside of randomized trials.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* More than 10 extraregional metastatic lesions at baseline staging.
* 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.
* Histology other than adenocarcinoma of the prostate.

Where it's running

• Affidea Nu-med Center of Oncological Diagnostics and Therapy
  Zamość, Lublin Voivodeship, Poland Recruiting

Study contacts

• Principal investigator: Mateusz Bilski, MD, PhD — Affidea Nu-med Center of Oncological DIagnostics and Therapy
• Study coordinator: Mateusz Bilski, MD, PhD
• Email: mateusz.bilski@affidea.com
• Phone: 81 536 04 50

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.