Neoadjuvant Weekly Ixabepilone for High Risk, Clinically Localized Prostate Cancer

• ClinicalTrials.gov Identifier: NCT00828308
• Recruitment Status: Completed
• First Posted: January 23, 2009
• Results First Posted: November 1, 2013
• Last Update Posted: March 8, 2022
• Sponsor: Brown University
• Collaborators: Rhode Island Hospital; The Miriam Hospital
• Information provided by (Responsible Party): Brown University

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)

Condition or disease	Intervention/treatment	Phase
Prostate Cancer	Drug: Ixabepilone; Procedure: Prostatectomy	Phase 2

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 16 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: BrUOG-PROS-221 Neoadjuvant Weekly Ixabepilone for High Risk, Clinically Localized Prostate Cancer: A Phase II Study
• Actual Study Start Date: February 2009
• Actual Primary Completion Date: March 2011
• Actual Study Completion Date: December 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Ixabepilone; 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: Ixabepilone; Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles.; Other Name: Ixempra; Procedure: Prostatectomy; Prostatectomy 2-8 weeks after completion ***this was standard of care and not a part of the study**; Other Name: Prostatectomy 2-8 weeks after completion ***this was standard of care and not a part of the study**

Outcome Measures

Primary Outcome Measures :

1. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Rhode Island

Miriam Hospital

Providence, Rhode Island, United States, 02906

Sponsors and Collaborators

Brown University

Rhode Island Hospital

The Miriam Hospital

Investigators

• Study Chair: Howard Safran, MD; BrUOG Study Chair

More Information

Additional Information:

ASCO abstract 

• Responsible Party: Brown University
• ClinicalTrials.gov Identifier: NCT00828308
• Other Study ID Numbers: BrUOG-Pros-221
• First Posted: January 23, 2009
• Results First Posted: November 1, 2013
• Last Update Posted: March 8, 2022
• Last Verified: February 2022

Keywords provided by Brown University:

localized; high risk; prostate cancer; neoadjuvant treatment

Additional relevant MeSH terms:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Prostatic Diseases