NCT00828308

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_2 prostate-cancer

Timeline
Completed

Started Feb 2009

Longer than P75 for phase_2 prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 23, 2009

Completed
9 days until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

November 1, 2013

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 8, 2022

Status Verified

February 1, 2022

Enrollment Period

2.1 years

First QC Date

January 22, 2009

Results QC Date

August 20, 2013

Last Update Submit

February 23, 2022

Conditions

Prostate Cancer

Keywords

localizedhigh riskprostate cancerneoadjuvant treatment

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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\*\*\*

Drug: IxabepiloneProcedure: Prostatectomy

Interventions

IxabepiloneDRUG

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

Also known as: Ixempra
Ixabepilone
ProstatectomyPROCEDURE

Prostatectomy 2-8 weeks after completion \*\*\*this was standard of care and not a part of the study\*\*

Also known as: Prostatectomy 2-8 weeks after completion ***this was standard of care and not a part of the study**
Ixabepilone

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • +7 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

ixabepiloneProstatectomy

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Urologic Surgical Procedures, MaleUrologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Results Point of Contact

Title
Anthony Mega, MD
Organization
BrUOG
BrUOG@brown.edu
4018633000

Study Officials

  • Howard Safran, MD

    BrUOG Study Chair

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2009

First Posted

January 23, 2009

Study Start

February 1, 2009

Primary Completion

March 1, 2011

Study Completion

December 1, 2016

Last Updated

March 8, 2022

Results First Posted

November 1, 2013

Record last verified: 2022-02

Locations

US(1)