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BrUOG-PROS-221 Neoadjuvant Weekly Ixabepilone for High Risk, Clinically Localized Prostate Cancer: A Phase II Study

Phase 2
18 Years
Open (Enrolling)
Prostate Cancer

Thank you

Trial Information

BrUOG-PROS-221 Neoadjuvant Weekly Ixabepilone for High Risk, Clinically Localized Prostate Cancer: A Phase II Study

Ixabepilone will be given IV weekly for 12 weeks, in an intensive 20 mg/m2/week schedule,
prior to prostatectomy for patients with localized, high risk prostate cancer. The objective
of this study is to determine the PSA response and pathologic complete response of weekly

Inclusion Criteria:

- Histologic documentation of prostatic adenocarcinoma. Patients with small cell,
neuroendocrine or transitional cell carcinomas are not eligible.

- All eligible patients must have a known Gleason sum based on biopsy or TURP at the
time of registration.

- Clinically Localized Disease: Patients must have clinical stage T1-T3a and no
radiographic evidence of metastatic disease as demonstrated by:

- Either CT or MRI of the abdomen and pelvis, that demonstrate no nodes > 1 cm: or
endorectal MRI(If one or more lymph nodes(s) measures > 1 cm, a negative biopsy is

- Negative bone scan (with plain films and /or MRI and/or CT scan confirmation, if
necessary).(Positive PET and Prostascint scans are not considered proof of metastatic

- Patients must have high risk disease defined as either:

- Gleason Score 8-10

- PSA > 15 ng/ml

- Stage T3a

- Stage T2c and Gleason score of 7

- Stage T2b, Gleason score of 7, greater than 50% of the cores positive from a
single lobe.

- No prior treatment for prostate cancer including prior surgery (excluding TURP),
pelvic lymph node dissection, radiation therapy, chemotherapy or hormone therapy.

- Patient must be appropriate candidates for radical prostatectomy with an estimated
life expectancy > 10 years as determined by an urologist.

- ECOG PS 0-1

- Age > 18 years of age.

- Required initial laboratory values:

- ANC > 1500/ul

- Platelet count > 100,000/mm3

- Creatinine < 2.0 mg/dl

- Serum PSA < 100 ng/ml

- Bilirubin < upper institutional limit of normal (ULN)

- AST/ALT < 2.5 X ULN

Exclusion Criteria:

- Active or uncontrolled infection.

- Patients must not have other coexistent medical condition that would preclude
protocol therapy.

- Previous severe hypersensitivity reaction to a drug formulated in CremophoreL
(polyoxyethylated castor oil).

- Grade 1 or greater neuropathy (motor or sensory) at study entry

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Prostate-Specific Antigen (PSA) response

Outcome Time Frame:

after 12 weeks of ixabepilone

Safety Issue:



United States: Institutional Review Board

Study ID:




Start Date:

January 2009

Completion Date:

July 2013

Related Keywords:

  • Prostate Cancer
  • localized
  • high risk
  • prostate cancer
  • neoadjuvant treatment
  • Prostatic Neoplasms



Miriam Hospital Providence, Rhode Island  02906