This is a randomized phase 3 trial aiming to compare the efficacy of docetaxel and hormone therapy as second line treatment in patients with mCRPC progressing after therapy with abiraterone or enzalutamide.
Patients will be randomized 1:1 to receive docetaxel or hormone therapy (abiraterone or enzalutamide based on previous treatment). Docetaxel (standard) will be administered for 10 cycles (maximum). Hormone therapy (experimental) will be administered until progression or unacceptable toxicity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Docetaxel 75 mg/m2 intravenous (iv) infusion every 3 weeks plus oral prednisone 5 mg twice daily for a maximum of 10 cycles.
Patient will receive Abiraterone or Enzalutamide based on previous treatment. Abiraterone given orally at the dose of 1000 mg daily plus oral prednisone 5 mg twice daily until progression or unacceptable toxicity. One course of therapy corresponds to four weeks of treatment. Enzalutamide given orally at the dose of 160 mg daily until progression or unacceptable toxicity. One course of therapy corresponds to four weeks of treatment.
Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico
Naples, Italy
Overall survival (OS)
OS is defined as the time from randomization until death
Time frame: up to 5 years
Progression free survival (PFS)
PFS is defined as the time elapsed from the date of randomization to the date of progression, as defined by investigators, or the date of death, whichever comes first.
Time frame: up to 5 years
Time to Prostate-Specific Antigen (PSA) Progression
as determined by investigator
Time frame: up to 5 years
Incidence of symptomatic skeletal events (SSE)
reporting the incidence and types of skeletal related events
Time frame: up to 5 years
Time to symptomatic skeletal event (SSE)
Time from the date of randomization to the date of documented symptomatic skeletal event
Time frame: up to 5 years
Time to Pain Progression
Time from the date of randomization to the date of pain progression
Time frame: up to 5 years
Number of participants with treatment-related side effects as assessed by Common Terminology Criteria for Adverse Event (CTCAE) version 5.0
graded according to Common Terminology Criteria for Adverse Event (CTCAE) version 5.0
Time frame: baseline, during treatment (every 4 weeks) up to 5 years
Determination of changes in quality of life
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EORTC QLQ-C30, a quality of life questionnaires, composed by 30 items graded from1 (not at all) to 4 (very much) after 1 year from the diagnosis
Time frame: baseline, during treatment up to 5 years
Radiographic response (bone lesions)
Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time frame: up to 5 years
Radiographic response (soft tissue lesions)
Prostate Cancer Working Group 3 (PCWG3) criteria
Time frame: up to 5 years