NCT06473259

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 Therapy (Alone or in Combination) or Radiotherapy on the Primary Tumor in Combination With Androgen Deprivation Therapy in Metastatic Hormone-sensitive Prostate Cancer: Multicenter Observational Study of Patients Undergoing Treatment in Clinical Practice in Italian Hospitals

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (estimated)
• Sponsor: Santa Chiara Hospital · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: —

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

Conditions

• Prostate Cancer
• Hormone Sensitive Prostate Cancer
• Metastatic Tumor

Interventions

Type	Name	Description
DRUG	Docetaxel	6 courses of docetaxel 75 mg/sqm iv
DRUG	Apalutamide Oral Tablet	240 mg /daily orally
DRUG	Enzalutamide Oral Tablet	600 mg /daily orally
DRUG	Abiraterone acetate tablets	1000 mg /daily orally
DRUG	Darolutamide Oral Tablet	600 mg/daily orally
RADIATION	radiotherapy	radical radiotherapy on primary tumor
DRUG	Triptorelin	3,75 mg im/4 w

Timeline

• Start date: 2016-12-16
• Primary completion: 2026-12-01
• Completion: 2028-12-01
• First posted: 2024-06-25
• Last updated: 2024-06-25

Locations

3 sites across 1 country: Italy