Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hormone Sensitive Prostate Cancer | — | UNRESOLVED | — |
| Metastatic Tumor | Neoplasm | CURATED_BROADER | 0.78 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abiraterone acetate tablets | Drug | Abiraterone | ALIAS |
| Apalutamide Oral Tablet | Drug | Apalutamide | ALIAS |
| Darolutamide Oral Tablet | Drug | Darolutamide | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Enzalutamide Oral Tablet | Drug | Enzalutamide | ALIAS |
| radiotherapy | Radiation | — | UNRESOLVED |
| Triptorelin | Drug | Triptorelin | ALIAS |
Design
Arms and outcomes
Arms (4)
- label
- ADT + docetaxel
- description
- mHSPC patients treated with ADT + docetaxel
- interventionNames
- Drug: Docetaxel
- Drug: Triptorelin
- label
- ADT + ARPI
- description
- mHSPC patients treated with ADT + ARPI
- interventionNames
- Drug: Apalutamide Oral Tablet
- Drug: Enzalutamide Oral Tablet
- Drug: Abiraterone acetate tablets
- Drug: Triptorelin
- label
- ADT + ARPI + docetaxel
- description
- mHSPC patients treated with ADT + docetaxel + ARPI
- interventionNames
- Drug: Docetaxel
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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
References
Publications (0)
Data not yet available