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Cabazitaxel and Radiation For Patients With Pathologically Determined Stage 3 Prostate Cancer and/or Patients With PSA Elevation (>0.1- < 2.0 ng/mL) Following Radical Prostatectomy

Phase 2
18 Years
Open (Enrolling)
Prostate Cancer

Thank you

Trial Information

Cabazitaxel and Radiation For Patients With Pathologically Determined Stage 3 Prostate Cancer and/or Patients With PSA Elevation (>0.1- < 2.0 ng/mL) Following Radical Prostatectomy

Inclusion Criteria

Conditions for Patient Eligibility

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

- Radical prostatectomy for adenocarcinoma of the prostate with at least one of the

- 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

- 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;

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the maximum tolerated dose of cabazitaxel with concurrent adjuvant radiation

Outcome Time Frame:

2 mos

Safety Issue:


Principal Investigator

Howard Safran, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Brown University Oncology Research Group


United States: Food and Drug Administration

Study ID:

BrUOG 246



Start Date:

January 2013

Completion Date:

January 2016

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Radical prostatectomy
  • Prostatic Neoplasms



Miriam Hospital Providence, Rhode Island  02906