NCT00769795

Brief Summary

The purpose of this study is to determine whether combination treatment of prostate cancer with IMC-A12 (an antibody which blocks insulin-like growth factor receptor activity) with hormonal therapy (testosterone lowering) before prostatectomy, will be more effective than prior results with hormonal therapy alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at P25-P50 for phase_2 prostate-cancer

Timeline
Completed

Started Oct 2008

Geographic Reach
1 country

3 active sites

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

Study Start

First participant enrolled

October 1, 2008

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 9, 2008

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

March 29, 2017

Status Verified

March 1, 2017

Enrollment Period

2.8 years

First QC Date

October 7, 2008

Last Update Submit

March 28, 2017

Conditions

Prostate Cancer

Keywords

prostate cancerprostatic neoplasmandrogen deprivation therapyinsulin-like growth factor receptor Ineoadjuvantprostatectomy

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint of the study is to determine the effects of combining androgen deprivation with IMC-A12 on pathologic tumor stage (pathologic complete response).

    At the time of prostatectomy after 3 months of treatment

Study Arms (1)

Experimental

EXPERIMENTAL

Bicalutamide 50 mg daily for 12 weeks Goserelin 10.8 mg SC once IMC-A12 10 mg/kg IV every three weeks for 12 weeks

Drug: IMC-A12Drug: BicalutamideDrug: Goserelin

Interventions

IMC-A12DRUG

IMC-A12 will be administered every 2 weeks for a total of 6 doses at 10 mg/kg per dose. The last dose of IMC-A12 will be at least 2 weeks prior to prostatectomy.

Also known as: Cixutumumab
Experimental
BicalutamideDRUG

Bicalutamide 50 mg daily orally for 12 weeks

Experimental
GoserelinDRUG

10.8 mg subcutaneous once

Experimental

Eligibility Criteria

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

You may qualify if:

  • Men 18 years or older with clinically localized prostate cancer who have chosen surgery (prostatectomy) and are at high risk of cancer relapse due to clinical stage, Gleason Score, PSA level, or a combination of the three.
  • Good health and laboratory values within reasonable limits

You may not qualify if:

  • Patients with prostate cancer that has spread outside the prostate.
  • Patients who have low testosterone
  • Patients who have received hormonal therapies or drugs which affect hormone metabolism
  • Patients with serious medical conditions such as diabetes, other cancers, stroke, cardiovascular disease.
  • Patients who are receiving other investigational therapy or chemotherapy.
  • Patients who are unwilling to use contraceptives during and for a short time after the study
  • Inability to give informed consent for any reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Related Publications (1)

  • Dean JP, Sprenger CC, Wan J, Haugk K, Ellis WJ, Lin DW, Corman JM, Dalkin BL, Mostaghel E, Nelson PS, Cohen P, Montgomery B, Plymate SR. Response of the insulin-like growth factor (IGF) system to IGF-IR inhibition and androgen deprivation in a neoadjuvant prostate cancer trial: effects of obesity and androgen deprivation. J Clin Endocrinol Metab. 2013 May;98(5):E820-8. doi: 10.1210/jc.2012-3856. Epub 2013 Mar 26.

    PMID: 23533230DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

cixutumumabbicalutamideGoserelin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Bruce Montgomery, M.D.

    University of Washington and Seattle Cancer Care Alliance

    PRINCIPAL INVESTIGATOR

  • James P Dean, M.D., Ph.D.

    University of Washington and Seattle Cancer Care Alliance

    PRINCIPAL INVESTIGATOR

  • Stephen Plymate, M.D.

    University of Washington

    PRINCIPAL INVESTIGATOR

  • John M Corman, MD

    Virginia Mason Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 7, 2008

First Posted

October 9, 2008

Study Start

October 1, 2008

Primary Completion

August 1, 2011

Study Completion

November 1, 2011

Last Updated

March 29, 2017

Record last verified: 2017-03

Locations

US(3)