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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

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Observational
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Poland
Affidea Nu-med Center of Oncological Diagnostics and Therapy
RECRUITING
Zamość
Contact Information
Primary
Mateusz Bilski, MD, PhD
mateusz.bilski@affidea.com
81 536 04 50
Backup
Paulina Kleban
paulina.kleban@affidea.com
81 536 04 50
Time Frame
Start Date: 2026-06-26
Estimated Completion Date: 2029-12-30
Participants
Target number of participants: 700
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Affidea Nu-med Center of Oncological DIagnostics and Therapy

This content was sourced from clinicaltrials.gov

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