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Recruiting NCT06473259

Evaluation of Clinical Outcomes of Chemotherapy or Androgen-receptor Targeting Agent (Alone or Combined) or Radiotherapy on Primary Tumor in Addition to Androgen Deprivation Therapy in HOrmone-Sensitive Metastatic Prostate Cancer Patients

Trial Parameters

Condition Prostate Cancer
Sponsor Santa Chiara Hospital
Study Type OBSERVATIONAL
Phase N/A
Enrollment 3,000
Sex MALE
Min Age N/A
Max Age N/A
Start Date 2016-12-16
Completion 2026-12
Interventions
DocetaxelApalutamide Oral TabletEnzalutamide Oral Tablet

Brief Summary

The aim of this observational study is to evaluate the clinical outcomes of treatment with docetaxel, ARTA (alone or in combination) or with radiotherapy on the primary tumor for mCSPC, in an unselected population, in clinical practice

Eligibility Criteria

Inclusion Criteria: 1. histologically confirmed diagnosis of adenocarcinoma of the prostate, metastatic, not undergoing previous treatment (except hormone therapy initiated no more than 4-6 months prior to docetaxel) for metastatic disease 2. treatment with docetaxel, ARPI (alone or in combination) or with radiation therapy on the primary tumor in combination with ADT within normal clinical practice or expanded access programs initiated between January 2015 and December 2027. 3. availability of inpatient and/or outpatient medical records for clinical data collection Exclusion Criteria: 1. histological diagnosis other than adenocarcinoma 2. patients who have received multiple lines of ADT for mCSPC 3. patients who have received docetaxel or ARTA for metastatic castration-resistant disease

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