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.
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.
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.
Patients with synchronous de novo oligometastatic prostate cancer, defined as metastatic prostate adenocarcinoma diagnosed at initial presentation or within 6 months of primary diagnosis, with up to 10 extraregional metastatic lesions. Patients are treated in routine clinical practice with definitive prostate-directed radiotherapy, which may include external-beam radiotherapy, brachytherapy boost, or definitive brachytherapy monotherapy, and metastasis-directed radiotherapy to all identified extraregional metastatic lesions.
Cohort
Other
Definitive Prostate-Directed Radiotherapy
RadiationDefinitive 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
RadiationStereotactic 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
RadiationElective 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
RadiationHigh-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.
Time to First Radiographic Progression
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
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.
Time to Polymetastatic Progression
Time from the start date of the first radiotherapy course to development of polymetastatic progression, defined as more than five new and/or regrowing extraregional metastatic lesions.
Time to Next-Line Systemic Therapy
Time from the start date of the first radiotherapy course to initiation or escalation of the next line of systemic therapy following radiographic progression or a documented clinical decision to intensify treatment.
Overall Survival
Time from the start date of the first radiotherapy course to death from any cause. Patients alive at last available follow-up will be censored at the date of last known vital status.
Treatment-Related Adverse Events
Frequency and severity of treatment-related adverse events recorded during routine care and graded according to CTCAE version 5.0 where available. Genitourinary and gastrointestinal adverse events will be summarized separately, including grade 3 or higher adverse events.
Exploratory Associations Between Treatment Factors and Outcomes
Exploratory analyses will evaluate associations between outcomes and baseline metastatic burden, imaging modality, metastatic site distribution, prostate radiotherapy modality, brachytherapy boost or monotherapy, pelvic lymph node irradiation, metastasis-directed radiotherapy dose and fractionation, systemic therapy intensity, and treatment sequence.
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