cabazitaxel and radiation for patients with prostate cancer

Conditions: Prostate Cancer

Summary: there is a high relapse rate for patients who have undergone prostatectomy and have pathologic extracapsular prostate extension, positive surgical margins or seminal vesicle involvement (pathologic stage 3 disease). while adjuvant radiation improves progression-free and overall survival, approximately half of these patients will develop recurrence. similarly, radiation therapy has become the standard salvage therapy for patients with rising psa \>0.1 - \ 0.1 - \< 2.0 ng/ml).


Eligibility criteria:
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 \ 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;

Keywords: prostate cancer radical prostatectomy