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

• Conditions: Prostate Cancer; Hormone Sensitive Prostate Cancer; Metastatic Tumor
• Interventions: Radiation: radiotherapy; Drug: Docetaxel; Drug: Apalutamide Oral Tablet; Drug: Darolutamide Oral Tablet; Drug: Enzalutamide Oral Tablet; Drug: Abiraterone acetate tablets; Drug: Triptorelin

• Registration Number: NCT06473259
• Lead Sponsor: Santa Chiara Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-16
• Study First Submitted: 2024-05-28
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-24
• Last Update Submitted: 2024-06-24
• Study First Posted: 2024-06-25
• Last Update Posted: 2024-06-25
• Primary Completion: 2026-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 3000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ADT + ARPI + docetaxel	Darolutamide Oral Tablet	mHSPC patients treated with ADT + docetaxel + ARPI
ADT + radiotherapy on primary tumor	radiotherapy	mHSPC patients treated with ADT + radiotherapy on primary tumor
ADT + docetaxel	Docetaxel	mHSPC patients treated with ADT + docetaxel
ADT + ARPI	Abiraterone acetate tablets	mHSPC patients treated with ADT + ARPI
ADT + ARPI + docetaxel	Docetaxel	mHSPC patients treated with ADT + docetaxel + ARPI
ADT + ARPI + docetaxel	Triptorelin	mHSPC patients treated with ADT + docetaxel + ARPI
ADT + ARPI	Enzalutamide Oral Tablet	mHSPC patients treated with ADT + ARPI
ADT + ARPI	Apalutamide Oral Tablet	mHSPC patients treated with ADT + ARPI
ADT + ARPI	Triptorelin	mHSPC patients treated with ADT + ARPI
ADT + docetaxel	Triptorelin	mHSPC patients treated with ADT + docetaxel
ADT + radiotherapy on primary tumor	Triptorelin	mHSPC patients treated with ADT + radiotherapy on primary tumor

Primary Outcome Measures

Name	Time	Method
progression free survival	From date of treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months	the projected rate over the time of patients without progressive disease

Secondary Outcome Measures

Name	Time	Method
overall survival	From date of treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months	the projected rate over the time of alive patients

Trial Locations

Locations (3)

Azienda Ospedaliera San Luigi; 🇮🇹 Orbassano, Torino, Italy

Istituto Oncologico Veneto; 🇮🇹 Padova, Italy

Santa Chiara Hospital; 🇮🇹 Trento, Italy