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 statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
AgeNot listed
SponsorSanta Chiara Hospital

About this trial

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

Qualifiers

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

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.

availability of inpatient and/or outpatient medical records for clinical data collection

Disqualifiers

histological diagnosis other than adenocarcinoma

patients who have received multiple lines of ADT for mCSPC

patients who have received docetaxel or ARTA for metastatic castration-resistant disease

Trial design

Treatments tested in this trial

  • Docetaxel
  • Apalutamide Oral Tablet
  • Enzalutamide Oral Tablet
  • Abiraterone acetate tablets
  • Darolutamide Oral Tablet
  • radiotherapy
  • Triptorelin

Treatment groups

3,000 Participants
are divided into 4 treatment groups

Sponsors and collaborators