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;