Clinical trial NCT01750866 (phase 2, status: withdrawn)
Conditions: castrate-resistant metastatic prostate cancer
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: cabazitaxel, prednisone, granulocyte colony-stimulating factor (g-csf)
SMILES: [H][C@]12[C@H](OC(=O)C3=CC=CC=C3)[C@]3(O)C[C@H](OC(=O)[C@H](O)[C@@H](NC(=O)OC(C)(C)C)C4=CC=CC=C4)C(C)=C([C@@H](OC)C(=O)[C@]1(C)[C@H](C[C@H]1OC[C@@]21OC(C)=O)OC)C3(C)C, [H][C@@]12CC=C(C3=CC=CN=C3)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])CC=C2C[C@@H](O)CC[C@]12C
Reason stopped: 
    no accrual
  
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically proven, castrate-resistant metastatic prostate cancer without
             neuroendocrine differentiation or small cell histology

          -  Age ≥ 75 years of age

          -  Progressive disease despite:

          -  Previous therapy with docetaxel

          -  Progressive disease for study enrollment is defined by either:

          -  PSA criteria according to the Prostate Cancer Clinical Trials Working Group (PCWG2)
             criteria with a minimum of three rising PSA levels with an interval of ≥ 1 week
             between each determination and a PSA at the screening visit of ≥ 2 ng/ml

          -  Radiographic progression in soft tissue according to Response Evaluation Criteria in
             Solid Tumors (RECIST 1.1) criteria

          -  Appearance of two or more lesions on a bone

          -  Previous treatment with abiraterone acetate or enzalutamide is allowed, but last dose
             must be at least 14 days prior to enrollment in this trial.

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

          -  Ongoing androgen deprivation with a serum testosterone < 50 ng/dL

          -  A score of 8-14 on the Mini Nutritional Assessment (MNA) (normal nutritional status or
             at risk of malnutrition). MNA in Appendix 4 and available at www.mna-elderly.com.

          -  Patients must have the following laboratory values:

          -  Hematologic:

          -  Absolute Neutrophil Count (ANC) >/=1.5x109/L

          -  Hemoglobin (Hgb) >/=9 g/dl

          -  Platelets (plt) >/=100x109/L

          -  Biochemistry :

          -  Potassium within normal limits or correctable with supplements

          -  Total calcium (corrected for serum albumin) and phosphorus within normal limits Liver
             and Kidney Functions

          -  AST (aspartate aminotransferase/glutamic oxaloacetic transaminase/GOT)and ALT (alanine
             aminotransferase/glutamic pyruvic transaminase/GPT) ≤ 1.5 x Upper Limit of Normal
             (ULN)

          -  Serum bilirubin </= 1 x ULN

          -  Serum creatinine </= 1.5 x ULN. If creatinine is 1.0 to 1.5 x ULN, creatinine
             clearance will be calculated according to the CKD-EPI (Chronic Kidney Disease
             Epidemiology Collaboration) formula and only patients with a creatinine clearance > 60
             mL/min will be included.

          -  Life expectancy of ≥ 6 months

          -  No concomitant anticancer or investigational drug or participation in an
             investigational trial within 30 days of starting treatment with cabazitaxel. Treatment
             with nitrosoureas, mitomycin, or monoclonal antibodies, such as trastuzumab, must be ≥
             6 weeks

          -  Male participants with partners who are of child bearing potential must agree to use
             double barrier method of birth control 28 days prior to study entry, during the study
             and for 28 days following the last dose of cabazitaxel OR have history of a vasectomy.

          -  Signed informed consent indicating an understanding of the purpose of the study and
             the necessary procedures and willingness to participate

        Exclusion Criteria:

          -  History of severe hypersensitivity reaction (≥grade 3) to docetaxel and polysorbate 80
             containing drugs

          -  Uncontrolled severe illness or medical condition (including uncontrolled diabetes
             mellitus)

          -  Concurrent or planned treatment with strong inhibitors or strong inducers of
             cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are
             already on these treatments)

          -  Previous treatment with cabazitaxel

          -  Patients with Central Nervous System (CNS) metastasis. Patients without clinical signs
             or symptoms of CNS involvement are not required to have a CT/MRI of the brain

          -  Clinically significant cardiac disease within 6 months, including myocardial
             infarction, New York Heart Association (NYHA) Class III or IV heart disease, or left
             ventricular ejection fraction of < 50% at baseline for patients with a history of
             congestive heart failure.

          -  History of another malignancy in the previous 5 years with the exception of curatively
             treated non-melanomatous skin cancer.

          -  Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome
             (AIDS)-related illness due to potential pharmacokinetic interactions of therapy with
             cabazitaxel.

          -  Other severe acute or chronic medical or psychiatric conditions or laboratory
             abnormality that may increase the risk associated with study participation or study
             drug administration, 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 trial.

          -  Unresolved toxicities from previous chemotherapy which has not resolved to ≤ grade 1
             by CTCAE Version 4.02 criteria with the exception of alopecia or grade 2 peripheral
             neuropathy.

          -  Major surgery ≤ 2 weeks prior to the start of the study or who have not recovered from
             a previous surgery. (Placement of a venous access device within 2 weeks is permitted)