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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

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

Recruiting
Male
Phase N/A

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Overview

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

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

Study details
    Prostate Cancer
    Hormone Sensitive Prostate Cancer
    Metastatic Tumor

NCT06473259

Santa Chiara Hospital

15 October 2025

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