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

Sponsor
Affidea Nu-med Center of Oncological DIagnostics and Therapy
Study ID
NCT07686016
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Definitive Prostate-Directed Radiotherapy — RADIATION
    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 — RADIATION
    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 — RADIATION
    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 — RADIATION
    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 Details

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.

Key Dates

First listed
Jul 6, 2026
Start date
Jun 26, 2026
Status verified
Jul 2026
Primary completion
Dec 30, 2028
Completion
Dec 30, 2029

Study Design

Enrollment
700 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Time to First Radiographic Progression [ Time Frame: From start of first radiotherapy course to first radiographic progression or last follow-up, up to 36 months ]

Central Contacts

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