Prostate Radiotherapy and Metastasis-Directed Therapy in Synchronous Oligometastatic Prostate Cancer
SynSABR-PC
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
1 other identifier
observational
700
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2026
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 26, 2026
CompletedFirst Submitted
Initial submission to the registry
June 28, 2026
CompletedFirst Posted
Study publicly available on registry
July 6, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2029
July 6, 2026
July 1, 2026
2.5 years
June 28, 2026
July 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
From start of first radiotherapy course to first radiographic progression or last follow-up, up to 36 months
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.
At first documented radiographic progression or death, assessed up to 36 months.
Secondary Outcomes (4)
Time to Polymetastatic Progression
From start of first radiotherapy course to polymetastatic progression or last follow-up, up to 36 months
Time to Next-Line Systemic Therapy
From start of first radiotherapy course to next-line systemic therapy or last follow-up, up to 36 months
Overall Survival
From start of first radiotherapy course to death or last known follow-up, up to 60 months
Treatment-Related Adverse Events
From start of first radiotherapy course to last follow-up, up to 36 months
Other Outcomes (1)
Exploratory Associations Between Treatment Factors and Outcomes
From start of first radiotherapy course to last follow-up, up to 36 months
Study Arms (3)
Historical Retrospective Cohort
Eligible patients treated before registry activation. Baseline disease characteristics, imaging, treatment details, follow-up, radiographic progression, adverse events, subsequent therapy, and survival data are abstracted retrospectively from available medical records.
Ambispective Follow-Up Cohort
Eligible patients treated before registry activation who remain under follow-up. Baseline and treatment data are collected retrospectively, while follow-up updates after registry activation, including imaging, progression, subsequent therapy, adverse events, and survival, are collected prospectively where permitted.
Prospective Enrollment Cohort
Newly eligible patients identified from registry activation onward and entered prospectively before, during, or shortly after routine clinical decision-making for definitive prostate-directed radiotherapy and metastasis-directed therapy. Treatment is not assigned by the registry.
Interventions
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.
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.
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.
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.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Affidea Nu-med Center of Oncological Diagnostics and Therapy
Zamość, Lublin Voivodeship, 22-400, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mateusz Bilski, MD, PhD
Affidea Nu-med Center of Oncological DIagnostics and Therapy
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 3 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Medical Director and Head of Radiotherapy Department
Study Record Dates
First Submitted
June 28, 2026
First Posted
July 6, 2026
Study Start
June 26, 2026
Primary Completion (Estimated)
December 30, 2028
Study Completion (Estimated)
December 30, 2029
Last Updated
July 6, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will become available beginning 12 months after publication of the primary registry analysis and will remain available for 5 years.
- Access Criteria
- Data will be available to qualified researchers who submit a scientifically sound proposal approved by the study steering group. Data sharing will require a signed data use agreement and, where applicable, documentation of ethics or institutional approval. Shared data may be used only for the approved research purpose and may not be used to attempt participant re-identification.
De-identified individual participant data underlying the main published analyses may be shared after publication. The shared dataset may include baseline clinical characteristics, staging and imaging modality, metastatic burden and location, prostate-directed radiotherapy details including brachytherapy where applicable, metastasis-directed radiotherapy details, systemic therapy, follow-up, radiographic progression, pattern of failure, subsequent treatments, adverse events, survival status, and censoring information. Direct identifiers, free-text clinical notes, raw imaging files, and exact calendar dates that could enable re-identification will not be shared.