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
Condition: Prostate Cancer, Metastatic Prostate Cancer, Oligometastatic Prostate Cancer, Synchronous Oligometastatic Prostate Cancer
Study Type: Observational [Patient Registry]
Clinical Trials Identifier NCT 8-digits: NCT07686016
Sponsor: Affidea Nu-med Center of Oncological DIagnostics and Therapy
Phase:
Eligibility:
- Age: minimum 18 Years maximum N/A
- Gender: Male
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.
View trial on ClinicalTrials.gov