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About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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:
Inadequate renal and hepatic function, defined as:
Primary purpose
Allocation
Interventional model
Masking
18 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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