Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
British Columbia Cancer Agency
With
Sanofi
Ozmosis Research Inc.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Histological diagnosis of prostate adenocarcinoma.
Able and willing to provide informed consent and to comply with the study procedures
Age ≥18
Evidence of metastatic disease on a chest, abdominal, or pelvic CT scan and/or bone scan within 6 weeks of registration
Castration resistant disease defined as evidence of radiological and/or PSA progression despite castrate levels of testosterone (serum testosterone \< 50 ng/dL (1.7 nmol/L)). For PSA progression, there must be at least 2 sequential rises at a minimum of 1-week intervals. The first PSA value must be ≥ 2. (Prostate Cancer Working Group 2 (PCWG2) criteria)
Poor prognosis disease as defined by any of the following:
the presence of liver metastases OR development of castration-resistance within 12 months of orchiectomy or commencement of LHRH antagonist/agonist for metastatic disease OR the presence of 4 or more of the following factors:
LDH \> ULN
ECOG Performance status (PS) 2
visceral metastatic disease
serum albumin less than or equal to 4 g/dL
ALP \> ULN
or \< 36 months from commencement of initial androgen deprivation therapy to study enrollment
ECOG PS 0-2.
Adequate end-organ function within 14 days of registration:
Haemoglobin ≥ 90 g/L Neutrophils ≥ 1.5 x 109 /L Platelets ≥ 100 x 109/L AST \< 1.5 x ULN ALT \< 1.5 x ULN Bilirubin ≤ 1.0 x ULN (exceptions for Gilbert's syndrome) Creatinine ≤ 1.5 x ULN
At least 21 days have passed since completing radiotherapy (exception for radiotherapy: at least 7 days since completing a single fraction of ≤ 800 cGy to a restricted field or limited-field radiotherapy to non-marrow bearing area such as an extremity or orbit) at the time of randomization.
At least 21 days have passed since receiving any investigational agent at the time of registration.
At least 21 days have passed since major surgery.
Neuropathy ≤ grade 1 at the time of registration.
Has recovered from all therapy-related toxicity to ≤ grade 2 (except alopecia, anemia and any signs or symptoms of androgen deprivation therapy) at the time of registration.
Eligible for abiraterone acetate and/or enzalutamide as per standard of care practices.
You may not be if
Histologic evidence of small cell/neuroendocrine prostate cancer.
Other chemotherapy regimen beyond one prior course of docetaxel.
Previously received treatment with cabazitaxel.
Received any prior next-generation anti-androgen (e.g. enzalutamide, ARN-509) or CYP 17 inhibitors (e.g. abiraterone, TAK-700).
Other condition, illness, psychiatric condition, or laboratory abnormality that may increase the risk associated with administration of cabazitaxel, abiraterone or enzalutamide, study participation, or may interfere with the interpretation of study results and in the judgment of the investigator would make the patient inappropriate for entry into this study.
Clareo Health | Cabazitaxel vs Abiraterone or Enzalutamide in Patients With Poor Prognosis Metastatic Castration-resistant Prostate Cancer
