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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

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.

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Time to First Radiographic Progression — From start of first radiotherapy course to first radiographic progression or last follow-up, up to 36 months
  Time from the start date of the first radiotherapy course to the date of first radiographic progression documented on routine follow-up imaging. Radiographic progression includes new extraregional metastatic lesions, local recurrence, regional nodal recurrence, or unequivocal progression at previously treated metastatic sites.
• Number of Participants by First Radiographic Failure Pattern — At first documented radiographic progression or death, assessed up to 36 months.
  Number of participants classified according to the first radiographic failure pattern after comprehensive prostate-directed radiotherapy and metastasis-directed therapy. Each participant with radiographic progression will be assigned to one prespecified first-failure category based on investigator assessment of routine follow-up imaging and clinical documentation. Categories include local prostate or prostate-bed recurrence, regional nodal recurrence, progression at previously treated metastatic sites, new distant metastatic lesions, combined recurrence, oligometastatic progression, polymetastatic progression, or death without documented radiographic progression.

Trial sites (1)

More Affidea Nu-med Center of Oncological DIagnostics and Therapy trials in Poland

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