Cabazitaxel and Radiation For Patients With Prostate Cancer

Conditions for Patient Eligibility

Each patient must meet all of the following inclusion criteria to be enrolled in the study:

* Radical prostatectomy for adenocarcinoma of the prostate with at least one of the following:

  * Extracapsular tumor extension,
  * Positive surgical margins,
  * Seminal vesicle invasion
  * Regional lymph node positive (N1)
  * Post-prostatectomy PSA of \> 0.1 - \< 2.0 ng/mL at least 6 weeks after prostatectomy and within 30 days of registration in a patient with T2 or T3 disease at prostatectomy.
* No distant metastases.
* No prior pelvic or prostate radiation or chemotherapy for prostate cancer.
* ECOG performance status 0-1.
* Age\>18.
* Required entry laboratory parameters within 14 days of study entry: Granulocytes ≥ 1500 cells/mm3; platelet count ≥100,000 cells/mm3, Creatinine ≤ 1.5X upper limit of normal (if creatinine clearance 1.0-1.5x ULN, creatinine clearance will be calculated according to Chronic Kidney Disease Epidemiology Group formula and patients with creatinine clearance \< 60 ml/min should be excluded),19 .Hgb \> 9.0 g/dl, total bilirubin ≤ 1x ULN, and AST or ALT ≤ 2.5 x ULN.
* Life expectancy of at least 1 year.
* Must not have uncontrolled severe, intercurrent illness.
* No concurrent anticancer therapy.
* Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
* Signed study-specific consent form prior to study entry.
* Conditions for Patient Ineligibility

Patients meeting any of the following exclusion criteria are not to be enrolled in the study:

* Evidence of distant metastases (M1). Equivocal bone scans are allowed if plain films are negative for metastasis.
* Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up.
* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (For example, carcinoma in situ of the oral cavity or bladder are permissible).
* History of severe hypersensitivity (\> grade 3) reaction to Cabazitaxel or other drugs formulated with polysorbate 80.
* History of severe hypersensitivity (\> grade 3) to docetaxel.
* Any uncontrolled severe, intercurrent illness (including uncontrolled diabetes)
* At least 4 weeks since any major surgery.
* Patients on concurrent anticancer therapy.
* PSA \> 2ng/ml
* Concurrent or planned treatment with strong inhibitors or inducers of cytochrome p450 3A4/5 (a one-week wash out period is necessary for patients who are already on these treatments (see appendix H and I)
* Androgen deprivation therapy started prior to prostatectomy for \> 6 months duration;
* Neoadjuvant chemotherapy prior to prostatectomy;
* Prior cryosurgery or brachytherapy of the prostate; prostatectomy should be the primary treatment and not a salvage procedure;
* Prior pelvic radiotherapy;