NCT04139772Active, not recruitingPhase 3
A Randomized Multicenter Phase III Trial Comparing Docetaxel or Hormone Therapy as Second Line Treatment in Patients With Asymptomatic or Oligosymptomatic Metastatic Castration-resistent Prostate Cancer (mCRPC) Progressing After Abiraterone or Enzalutamide.
National Cancer Institute, Naples1 site in 1 country18 target enrollmentStarted: September 1, 2019Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Overall survival (OS)
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologically or cytologically confirmed adenocarcinoma of the prostate
- •Distant metastatic disease
- •Previous first line treatment with abiraterone or enzalutamide for 6 cycles interrupted at least 2 weeks before randomization
- •Patients must be ≥ 18 years of age
- •Patients must have castrate serum level of testosterone of < 0.5 ng/mL ( 1.7 nmol/L)
- •Asymptomatic or Oligosymptomatic disease
- •Progressive disease according to Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria
- •ECOG performance status (PS) of 0-2
- •Sexually active males must use an accepted and effective method birth control measure
- •Written informed consent
Exclusion Criteria
- •Prior exposure to docetaxel or abiraterone for treatment of hormone-sensitive metastatic prostate cancer (mHSPC)
- •History of adrenal insufficiency or hypoaldosteronism
- •Any medical condition that would make prednisone use contraindicated
- •Any medical condition that would make docetaxel use contraindicated
- •Patients unable to swallow orally administered medication
- •Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV) requiring antiretroviral therapy
- •Other malignancy within the last 5 years, except for adequately treated non melanoma skin cancer, bladder cancer (pTis, pTa, pT1) or other solid tumours curatively treated with no evidence of disease for > 5 years
- •Participation in another clinical study with an investigational product within 30 days prior to randomization
- •Persistent toxicities [>Common Terminology Criteria for Adverse Event (CTCAE) grade 1)] caused by previous cancer therapy prior to randomization
- •Uncontrolled medical conditions including diabetes mellitus. Clinically significant cardiovascular disease (e.g.: uncontrolled hypertension or arrhythmia, unstable angina pectoris, congestive heart failure (CHF), vascular disease (arterial thrombosis) and myocardial infarction within < 6 months
- •Left ventricular ejection fraction < 50%
- •Peripheral neuropathy [> CTCAE grade 2]
- •Inadequate bone marrow function defined as:
- •haemoglobin < 9.0 g/dL
- •absolute neutrophils count (ANC) <1.5 x 109/L (> 1500 per mm3)
- •platelet count <100 x 109/L (>100,000 per mm3)
- •Inadequate renal and hepatic function, defined as:
- •total serum bilirubin > 1,0 x ULN
- •AST/SGOT o ALT/SGPT > 1,5 x ULN
- •calculated creatinine clearance < 40 mL/min
- •potassium level < 3,5 mmol/L
- •Child-Pugh class C
Arms & Interventions
Docetaxel
Active Comparator
Docetaxel 75 mg/m2 intravenous (iv) infusion every 3 weeks plus oral prednisone 5 mg twice daily for a maximum of 10 cycles.
Intervention: Docetaxel (Drug)
Abiraterone or Enzalutamide
Experimental
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.
Intervention: Abiraterone Acetate or Enzalutamide (Drug)
Outcomes
Primary Outcomes
Overall survival (OS)
Time Frame: up to 5 years
OS is defined as the time from randomization until death
Secondary Outcomes
- Time to Prostate-Specific Antigen (PSA) Progression(up to 5 years)
- Progression free survival (PFS)(up to 5 years)
- Incidence of symptomatic skeletal events (SSE)(up to 5 years)
- Time to symptomatic skeletal event (SSE)(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(baseline, during treatment (every 4 weeks) up to 5 years)
- Time to Pain Progression(up to 5 years)
- Determination of changes in quality of life(baseline, during treatment up to 5 years)
- Radiographic response (bone lesions)(up to 5 years)
- Radiographic response (soft tissue lesions)(up to 5 years)
Investigators
Study Sites (1)
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