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.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
National Cancer Institute, Naples
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.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | 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.
