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
ID: NCT06473259
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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
6 courses of docetaxel 75 mg/sqm iv
240 mg /daily orally
600 mg /daily orally
1000 mg /daily orally
600 mg/daily orally
radical radiotherapy on primary tumor
3,75 mg im/4 w
Treatment Arms Description
mHSPC patients treated with ADT + docetaxel
mHSPC patients treated with ADT + ARPI
mHSPC patients treated with ADT + docetaxel + ARPI
mHSPC patients treated with ADT + radiotherapy on primary tumor
- 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
- 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
Primary Outcome Measures
- progression free survival — Time Frame: 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
View Secondary Outcome Measures (1)
- overall survival — Time Frame: 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
This trial is recruiting at 3 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:
Show All 3 Facilities & Contact Sites
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View Official Medical/Scientific Title
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