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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 3,000
- Locations
- 3
- Primary Endpoint
- progression free survival
Study Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •availability of inpatient and/or outpatient medical records for clinical data collection
Exclusion Criteria
- •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
Arms & Interventions
ADT + docetaxel
mHSPC patients treated with ADT + docetaxel
Intervention: Docetaxel (Drug)
ADT + docetaxel
mHSPC patients treated with ADT + docetaxel
Intervention: Triptorelin (Drug)
ADT + ARPI
mHSPC patients treated with ADT + ARPI
Intervention: Apalutamide Oral Tablet (Drug)
ADT + ARPI
mHSPC patients treated with ADT + ARPI
Intervention: Enzalutamide Oral Tablet (Drug)
ADT + ARPI
mHSPC patients treated with ADT + ARPI
Intervention: Abiraterone acetate tablets (Drug)
ADT + ARPI
mHSPC patients treated with ADT + ARPI
Intervention: Triptorelin (Drug)
ADT + ARPI + docetaxel
mHSPC patients treated with ADT + docetaxel + ARPI
Intervention: Docetaxel (Drug)
ADT + ARPI + docetaxel
mHSPC patients treated with ADT + docetaxel + ARPI
Intervention: Darolutamide Oral Tablet (Drug)
ADT + ARPI + docetaxel
mHSPC patients treated with ADT + docetaxel + ARPI
Intervention: Triptorelin (Drug)
ADT + radiotherapy on primary tumor
mHSPC patients treated with ADT + radiotherapy on primary tumor
Intervention: radiotherapy (Radiation)
ADT + radiotherapy on primary tumor
mHSPC patients treated with ADT + radiotherapy on primary tumor
Intervention: Triptorelin (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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)
Investigators
Orazio Caffo
Director
Santa Chiara Hospital