Clinical trial NCT01531205 (phase 2, status: terminated)
Conditions: prostate cancer
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: androgen ablation, cabazitaxel, salvage therapy, neoadjuvant treatment - hormonal therapy, neoadjuvant treatment - cabazitaxel
SMILES: CC(O)(CS(=O)(=O)C1=CC=C(F)C=C1)C(=O)NC1=CC(=C(C=C1)C#N)C(F)(F)F, [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, COC1=CC=CC=C1OC1=C(NS(=O)(=O)C2=CC=C(C=C2)C(C)(C)C)N=C(N=C1OCCO)C1=NC=CC=N1, [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
Reason stopped: 
    low accrual
  
Eligibility criteria:

        Inclusion Criteria:

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

          -  Life expectancy must be more than 10 years

          -  Peripheral neuropathy: must be </= grade 1

          -  A minimum PSA of 1 ng/ml if not on androgen deprivation therapy

          -  Patients must have one of the following criteria to be eligible:

               -  PSA recurrence with a doubling time of less than 9 months (calculated by at least
                  3 PSA values that were obtained at least 4 weeks apart)

               -  Prostatic biopsy Gleason Grade of >/= 8 at the time of initial biopsy prior to
                  radiation therapy and as determined by either an outside pathology report or on
                  review of slides by our institutional pathologist(s)

               -  Clinical stage of >/= T3 (defined as evidence of extracapsular or seminal vesicle
                  extension on digital rectal examination or transrectal ultrasonography) either at
                  the time of initial diagnosis or following radiotherapy

          -  Prior radiation therapy of any type including external beam radiotherapy,
             brachytherapy, high dose radiotherapy, or proton therapy

          -  Positive prostate biopsy documenting local recurrence following radiation therapy

          -  Prior androgen deprivation therapy up to a total duration of 36 months is allowable.

          -  Patients who are on LHRH analog therapy should continue such therapy provided that the
             patient does not have castration resistant prostate cancer (rising PSA in the presence
             of castrate levels of serum testosterone, ie < 50 ng/dl). Androgen deprivation therapy
             other than LHRH analog should be discontinued 4 weeks prior to study enrollment.

          -  All prostatic carcinoma variants except small cell carcinoma of the prostate will be
             allowed.

          -  Patients must have no evidence of metastatic diseases on the bone scan and an
             abdominal/pelvic CT or MRI performed within 30 days of study enrollment.

          -  All patients must be regarded as acceptable anesthetic risk for salvage surgery
             (salvage radical prostatectomy, salvage cystoprostatectomy, salvage total pelvic
             exenteration) and confirm their intention to undergo salvage surgery at the end of the
             neoadjuvant chemohormonal therapy.

          -  Patients must have adequate bone marrow function defined as an absolute peripheral
             granulocyte count of > 1,500/mm^3 and platelet count of > 100,000/mm^3; adequate
             hepatic function defined with a total bilirubin of < 1.5 mg/dl and aspartic
             transaminase/alanine transaminase (AST/ALT) < 1.5 X the upper limits of normal (ULN);
             adequate renal function defined as serum creatinine clearance > 60 ml/min (measured or
             calculated).

          -  Men and women of childbearing potential must be willing to consent to using effective
             contraception while on treatment and for at least 3 months thereafter.

          -  Patients must sign an informed consent indicating that they are aware of the
             investigational nature of this study, in keeping with the policies of the institution.

          -  All patients must be evaluated in the Department of Genitourinary Oncology prior to
             signing informed consent.

        Exclusion Criteria:

          -  Patients with small cell histology

          -  Patients with clinical, radiological, or pathological evidence of bone, lymph node or
             visceral metastasis (liver or lung metastasis)

          -  Castration resistant prostate cancer defined as rising PSA profile in setting of
             castrate levels of testosterone (serum testosterone < 50 ng/dl)

          -  Prior chemotherapy

          -  Patients with severe or uncontrolled intercurrent infection

          -  Patients with New York Heart Association (NYHA) Class III/IV congestive heart failure,
             unstable angina or history of myocardial infarction within the last 6 months

          -  Contraindications to corticosteroids

          -  Uncontrolled severe hypertension, persistently uncontrolled diabetes mellitus, oxygen
             dependent lung disease, chronic liver disease or HIV infection

          -  Second malignancies (excluding non-melanoma skin cancer) unless disease-free for 3
             years

          -  Overt psychosis, mental disability or otherwise incompetent to give informed consent

          -  Patients with a history of severe hypersensitivity reaction to Cabazitaxel® or other
             drugs formulated with polysorbate 80