Prostate CancerPhase 2NCT00828308
Neoadjuvant Weekly Ixabepilone for High Risk, Clinically Localized Prostate Cancer
A Phase 2 study testing Ixabepilone and Prostatectomy in people with Prostate Cancer, run by Brown University at 1 site in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Ixabepilone and Prostatectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Dec 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 22Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Ixabepilone, Prostatectomy
- Keywords
- localized, high risk, prostate cancer, neoadjuvant treatment
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IxabepiloneDrug
Also called Ixempra
Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles.
ProstatectomyProcedure or surgery
Also called Prostatectomy 2-8 weeks after completion ***this was standard of care and not a part of the study**
Prostatectomy 2-8 weeks after completion *this was standard of care and not a part of the study
| Study group | Role | What they receive |
|---|---|---|
| Ixabepilone | Experimental | 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* Receives: Drug: Ixabepilone; Procedure: Prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prostate-Specific Antigen (PSA) Response
Decrease in PSA:number of participants with decreased serum PSA level after 12 weeks of ixabepilone
Measured: after 12 weeks of ixabepilone
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completionMar 2011
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- Rhode Island Hospital, The Miriam Hospital
- Responsible party
- Sponsor
- Investigators
- Howard Safran, MD, Study chair, BrUOG Study Chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00828308
- Sponsor's protocol ID
- BrUOG-Pros-221
- Status last verified
- Feb 2022
- First submitted
- 22 Jan 2009
- Last updated
- 8 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BrUOG-PROS-221 Neoadjuvant Weekly Ixabepilone for High Risk, Clinically Localized Prostate Cancer: A Phase II Study
- ClinicalTrials.gov ID
- NCT00828308
- Acronym / sponsor ID
- BrUOG-Pros-221
- Conditions
- Prostate Cancer
- Keywords
- localized, high risk, prostate cancer, neoadjuvant treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- Rhode Island Hospital, The Miriam Hospital
- Study start
- Feb 2009 (actual)
- Primary completion
- Mar 2011 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 23 Jan 2009 (estimated)
- Results
- Posted 1 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ixabepilone | Experimental | Drug: Ixabepilone, Procedure: ProstatectomyIxabepilone, 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* |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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.)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IxabepiloneAlso: IxempraIxabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. | Drug | Ixabepilone |
| ProstatectomyAlso: Prostatectomy 2-8 weeks after completion ***this was standard of care and not a part of the study**Prostatectomy 2-8 weeks after completion *this was standard of care and not a part of the study | Procedure or surgery | Ixabepilone |
Primary outcome
Prostate-Specific Antigen (PSA) Response
Time frame: after 12 weeks of ixabepilone
Decrease in PSA:number of participants with decreased serum PSA level after 12 weeks of ixabepilone
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Howard Safran, MD study chair
BrUOG Study Chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ixabepilone and Prostatectomy in people with Prostate Cancer, run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prostate-Specific Antigen (PSA) Response (time frame: after 12 weeks of ixabepilone). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2022.