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 · NCT06473259 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Abiraterone acetate tabletsApalutamide Oral TabletDarolutamide Oral TabletDocetaxelEnzalutamide Oral TabletTriptorelinradiotherapy
What this trial is about
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
Who can take part
Age range
No age limits stated
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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
Where it is running
3 locations listed.
- Istituto Oncologico Veneto - Padova, Italy
- Santa Chiara Hospital - Trento, Italy
- Azienda Ospedaliera San Luigi - Orbassano, Torino, Italy