Cabazitaxel and Radiation For Patients With Prostate Cancer

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, Radical prostatectomy Read More

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;