Prostate Cancer, Hormone Sensitive Prostate Cancer, Metastatic Tumor
Conditions
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
Interventions
DRUGDocetaxel
6 courses of docetaxel 75 mg/sqm iv
DRUGApalutamide Oral Tablet
240 mg /daily orally
DRUGEnzalutamide Oral Tablet
600 mg /daily orally
1000 mg /daily orally
600 mg/daily orally
RADIATIONradiotherapy
radical radiotherapy on primary tumor
DRUGTriptorelin
3,75 mg im/4 w
Sponsors
Santa Chiara Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| rate of patients with an objective response | through study completion, an average of 2 year | rate of patients who experienced a reduction of at least 30% of measurable lesions |
Countries
Italy
Contacts
Primary ContactOrazio Caffo, MD
Outcome results
None listed