Prostate Cancer
Conditions
Keywords
localized, high risk, prostate cancer, neoadjuvant treatment
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.
Interventions
DRUGIxabepilone
Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles.
PROCEDUREProstatectomy
Prostatectomy 2-8 weeks after completion \*\*\*this was standard of care and not a part of the study\*\*
Sponsors
Rhode Island Hospital
The Miriam Hospital
Brown University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prostate-Specific Antigen (PSA) Response | after 12 weeks of ixabepilone | Decrease in PSA:number of participants with decreased serum PSA level after 12 weeks of ixabepilone |
Countries
United States
Participant flow
Recruitment details
First patient enrolled 2/11/09 and last patient enrolled was 3/30/11
Participants by arm
| Arm | Count |
|---|---|
| Ixabepilone Ixabepilone, 16 mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. Prostatectomy 2-8 weeks after completion of chemotherapy (this was standard of care and not a part of the study) | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | Ixabepilone |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Age, Continuous | 56.5 years STANDARD_DEVIATION 29 |
| Region of Enrollment United States | 16 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 16 / 16 |
| serious Total, serious adverse events | 1 / 16 |
Outcome results
Primary
Prostate-Specific Antigen (PSA) Response
Decrease in PSA:number of participants with decreased serum PSA level after 12 weeks of ixabepilone
Time frame: after 12 weeks of ixabepilone
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ixabepilone | Prostate-Specific Antigen (PSA) Response | 14 participants |