Neoadjuvant Weekly Ixabepilone for High Risk, Clinically Localized Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ixabepilone
Prostatectomy
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring localized, high risk, prostate cancer, neoadjuvant treatment
Eligibility Criteria
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
Sites / Locations
- Miriam Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ixabepilone
Arm Description
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***
Outcomes
Primary Outcome Measures
Prostate-Specific Antigen (PSA) Response
Decrease in PSA:number of participants with decreased serum PSA level after 12 weeks of ixabepilone
Secondary Outcome Measures
Full Information
NCT ID
NCT00828308
First Posted
January 22, 2009
Last Updated
February 23, 2022
Sponsor
Brown University
Collaborators
Rhode Island Hospital, The Miriam Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00828308
Brief Title
Neoadjuvant Weekly Ixabepilone for High Risk, Clinically Localized Prostate Cancer
Official Title
BrUOG-PROS-221 Neoadjuvant Weekly Ixabepilone for High Risk, Clinically Localized Prostate Cancer: A Phase II Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
February 2009 (Actual)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Brown University
Collaborators
Rhode Island Hospital, The Miriam Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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)
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
localized, high risk, prostate cancer, neoadjuvant treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ixabepilone
Arm Type
Experimental
Arm Description
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***
Intervention Type
Drug
Intervention Name(s)
Ixabepilone
Other Intervention Name(s)
Ixempra
Intervention Description
Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles.
Intervention Type
Procedure
Intervention Name(s)
Prostatectomy
Other Intervention Name(s)
Prostatectomy 2-8 weeks after completion ***this was standard of care and not a part of the study**
Intervention Description
Prostatectomy 2-8 weeks after completion ***this was standard of care and not a part of the study**
Primary Outcome Measure Information:
Title
Prostate-Specific Antigen (PSA) Response
Description
Decrease in PSA:number of participants with decreased serum PSA level after 12 weeks of ixabepilone
Time Frame
after 12 weeks of ixabepilone
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard Safran, MD
Organizational Affiliation
BrUOG Study Chair
Official's Role
Study Chair
Facility Information:
Facility Name
Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
12. IPD Sharing Statement
Links:
URL
http://meetinglibrary.asco.org/content/89343-116
Description
ASCO abstract
Learn more about this trial
Neoadjuvant Weekly Ixabepilone for High Risk, Clinically Localized Prostate Cancer
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