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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

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring localized, high risk, prostate cancer, neoadjuvant treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

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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