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

Sponsor
Santa Chiara Hospital
Study ID
NCT06473259
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Docetaxel — DRUG
    6 courses of docetaxel 75 mg/sqm iv
  • Apalutamide Oral Tablet — DRUG
    240 mg /daily orally
  • Enzalutamide Oral Tablet — DRUG
    600 mg /daily orally
  • Abiraterone acetate tablets — DRUG
    1000 mg /daily orally
  • Darolutamide Oral Tablet — DRUG
    600 mg/daily orally
  • radiotherapy — RADIATION
    radical radiotherapy on primary tumor
  • Triptorelin — DRUG
    3,75 mg im/4 w

Study Details

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

Key Dates

Start date
Dec 16, 2016
Status verified
Jun 2024
Primary completion
Dec 31, 2026
Completion
Dec 31, 2028

Study Design

Enrollment
3,000 participants (estimated)

Arms

  • Arm: ADT + docetaxel
    mHSPC patients treated with ADT + docetaxel
  • Arm: ADT + ARPI
    mHSPC patients treated with ADT + ARPI
  • Arm: ADT + ARPI + docetaxel
    mHSPC patients treated with ADT + docetaxel + ARPI
  • Arm: ADT + radiotherapy on primary tumor
    mHSPC patients treated with ADT + radiotherapy on primary tumor

Primary Outcome Measure

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 ]

Central Contacts

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