Clinical trial · Interventional
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
NCT00828308CI-TRIAL-00056932completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ixabepilone | Drug | — | UNRESOLVED |
| Prostatectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ixabepilone
- 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\*\*\*
- interventionNames
- Drug: Ixabepilone
- Procedure: Prostatectomy
Primary outcomes (1)
- measure
- Prostate-Specific Antigen (PSA) Response
- timeFrame
- after 12 weeks of ixabepilone
- description
- Decrease in PSA:number of participants with decreased serum PSA level after 12 weeks of ixabepilone
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.