Neoadjuvant Weekly Ixabepilone for High Risk, Clinically Localized Prostate Cancer

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

Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles.

Prostatectomy 2-8 weeks after completion(standard of care and not a part of study)

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Ixabepilone; Procedure: Prostatectomy

Detailed Description

Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. Prostatectomy 2-8 weeks after completion of chemotherapy (this was standard of care).

This protocol evaluated weekly ixabepilone prior to robotic prostatectomy for patients with high risk localized prostate cancer. PSA response rate, tumor margin status and pathologic responses were assessed.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Miriam Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 required.)
• 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 disease.)

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ixabepilone; Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. Prostatectomy 2-8 weeks after completion ***this was standard of care and not a part of the study***	Drug: Ixabepilone; Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles.; Other Names: Ixempra; Procedure: Prostatectomy; Prostatectomy 2-8 weeks after completion ***this was standard of care and not a part of the study**; Other Names: Prostatectomy 2-8 weeks after completion ***this was standard of care and not a part of the study**

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prostate-Specific Antigen (PSA) Response	Decrease in PSA:number of participants with decreased serum PSA level after 12 weeks of ixabepilone	after 12 weeks of ixabepilone

Collaborators and Investigators

• Sponsor: Brown University
• Collaborators: The Miriam Hospital; Rhode Island Hospital
• Investigators: Study Chair: Howard Safran, MD, BrUOG Study Chair

Publications and helpful links

Helpful Links

• ASCO abstract

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2009
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: January 22, 2009
• First Submitted That Met QC Criteria: January 22, 2009
• First Posted (Estimate): January 23, 2009

Study Record Updates

• Last Update Posted (Actual): March 8, 2022
• Last Update Submitted That Met QC Criteria: February 23, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: prostate cancer; neoadjuvant treatment; high risk; localized
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: BrUOG-Pros-221