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.

• Status: Active, not recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute, Naples
• Treatments: Abiraterone Acetate; Docetaxel; Hormones; Prednisone

Criteria

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