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 (ECHOS)

Santa Chiara Hospital

Status: Enrolling

Conditions: Metastatic Tumor; Hormone Sensitive Prostate Cancer; Prostate Cancer

Treatments: Radiation: radiotherapy; Drug: Docetaxel; Drug: Enzalutamide Oral Tablet; Drug: Apalutamide Oral Tablet; Drug: Darolutamide Oral Tablet; Drug: Triptorelin; Drug: Abiraterone acetate tablets

Study type: Observational

Funder types: Other

Identifiers

NCT06473259

A349

Details and patient eligibility

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

Enrollment: 3,000 estimated patients

Sex: Male

Volunteers: No Healthy Volunteers

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

Trial design

3,000 participants in 4 patient groups

ADT + docetaxel

Description:

mHSPC patients treated with ADT + docetaxel

Treatment:

Drug: Triptorelin

Drug: Docetaxel

ADT + ARPI

Description:

mHSPC patients treated with ADT + ARPI

Treatment:

Drug: Abiraterone acetate tablets

Drug: Triptorelin

Drug: Apalutamide Oral Tablet

Drug: Enzalutamide Oral Tablet

ADT + ARPI + docetaxel

Description:

mHSPC patients treated with ADT + docetaxel + ARPI

Treatment:

Drug: Triptorelin

Drug: Darolutamide Oral Tablet

Drug: Docetaxel

ADT + radiotherapy on primary tumor

Description:

mHSPC patients treated with ADT + radiotherapy on primary tumor

Treatment:

Drug: Triptorelin

Radiation: radiotherapy