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

Summary

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.

Conditions

• Prostate Cancer
• Metastatic Prostate Cancer
• Oligometastatic Prostate Cancer
• Synchronous Oligometastatic Prostate Cancer

Interventions

RADIATION

Definitive Prostate-Directed Radiotherapy

Definitive radiotherapy to the prostate delivered as part of routine clinical practice. Techniques may include external-beam radiotherapy, moderately hypofractionated radiotherapy, ultra-hypofractionated prostate radiotherapy, external-beam radiotherapy with brachytherapy boost, or definitive prostate brachytherapy monotherapy in selected patients.

RADIATION

Metastasis-Directed Stereotactic Body Radiotherapy

Stereotactic body radiotherapy delivered with ablative intent to all identified extraregional metastatic lesions at baseline. Dose, fractionation, target site, number of treated lesions, and treatment sequence are determined by routine institutional practice and recorded in the registry.

RADIATION

Pelvic Lymph Node Irradiation

Elective or definitive pelvic lymph node irradiation, with or without dose escalation to involved pelvic lymph nodes, delivered according to institutional standards. This treatment is permitted but not mandatory and is recorded as a treatment-related variable.

RADIATION

Prostate Brachytherapy

High-dose-rate or low-dose-rate prostate brachytherapy delivered either as a boost after external-beam radiotherapy or as definitive brachytherapy monotherapy in selected patients, according to institutional practice.

Sponsors & Collaborators

• Affidea Nu-med Center of Oncological DIagnostics and Therapy

  lead OTHER

Principal Investigators

• Mateusz Bilski, MD, PhD · Affidea Nu-med Center of Oncological DIagnostics and Therapy

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-26

Primary Completion

2028-12-30

Completion

2029-12-30

Countries

• Poland

Study Locations