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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Docetaxel, Apalutamide Oral Tablet, Enzalutamide Oral Tablet, Abiraterone acetate tablets.
- Who it may be relevant to
- Registry conditions: Prostate Cancer, Hormone Sensitive Prostate Cancer, Metastatic Tumor. Basic parameters: No limits · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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
- 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
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]
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]
Eligibility criteria
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 2027.
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Italy · 3 centers
- Azienda Ospedaliera San Luigi — Orbassano
- Istituto Oncologico Veneto — Padova
- Santa Chiara Hospital — Trento
Identifiers
NCT: NCT06473259 · A349