RecruitingNCT06473259

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


Sponsor

Santa Chiara Hospital

Enrollment

3,000 participants

Start Date

Dec 16, 2016

Study Type

OBSERVATIONAL

Conditions

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


Eligibility

Sex: MALE

Plain Language Summary

Simplified for easier understanding

This study is collecting real-world data on men with metastatic prostate cancer — cancer that has spread beyond the prostate — to better understand how different treatment combinations (chemotherapy, hormone-blocking drugs, or radiation) affect outcomes in everyday clinical practice. **You may be eligible if...** - You have been diagnosed with prostate cancer that has spread (metastatic disease) - You received treatment with docetaxel (a chemotherapy), hormone-blocking drugs (called ARPIs), or radiation between January 2015 and December 2027 - Your medical records are available for data collection - You had not previously received treatment for the metastatic stage (aside from hormonal therapy started up to 6 months before docetaxel) **You may NOT be eligible if...** - Your cancer type is not adenocarcinoma (the most common type) - You received multiple lines of hormone-blocking therapy before this stage - You already received chemotherapy or hormone-blocking drugs for treatment-resistant (castration-resistant) prostate cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDocetaxel

6 courses of docetaxel 75 mg/sqm iv

DRUGApalutamide Oral Tablet

240 mg /daily orally

DRUGEnzalutamide Oral Tablet

600 mg /daily orally

DRUGAbiraterone acetate tablets

1000 mg /daily orally

DRUGDarolutamide Oral Tablet

600 mg/daily orally

RADIATIONradiotherapy

radical radiotherapy on primary tumor

DRUGTriptorelin

3,75 mg im/4 w


Locations(3)

Azienda Ospedaliera San Luigi

Orbassano, Torino, Italy

Istituto Oncologico Veneto

Padova, Italy

Santa Chiara Hospital

Trento, Italy

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NCT06473259


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