๐ฌIn plain words
What the trial is, and whether it could suit you
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
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
๐
What it tests
- Definitive Prostate-Directed Radiotherapy
- Metastasis-Directed Stereotactic Body Radiotherapy
- Pelvic Lymph Node Irradiation
- Prostate Brachytherapy
Affidea Nu-med Center of Oncological Diagnostics and Therapy
Zamoลฤ, Poland
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.
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