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Study of Effectiveness of IMC-A12 Antibody Combined With Hormone Therapy Prior to Surgery to Treat Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00769795
Recruitment Status : Completed
First Posted : October 9, 2008
Last Update Posted : March 29, 2017
Sponsor:
Information provided by (Responsible Party):
Bruce Montgomery, Fred Hutchinson Cancer Research Center

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: IMC-A12 Drug: Bicalutamide Drug: Goserelin Phase 2

Detailed Description:

Androgen deprivation has long been the principal means of controlling advanced prostate cancer, but it does not cure the disease and all patients ultimately progress if tumor is not eliminated with definitive local therapy. Neoadjuvant androgen deprivation prior to radical prostatectomy can downstage localized disease and reduce the likelihood of residual disease at the margins, but does not improve failure free survival. It has been demonstrated that despite androgen deprivation with luteinizing hormone releasing hormone (LHRH) agonists or orchiectomy, prostate tissue and prostate cancer maintain levels of androgens which are more than adequate to continue to stimulate the androgen receptor and downstream signaling. These levels of androgen may continue to allow both survival of tumor cells and induction of resistance by overexpression of receptor.

The anti-insulin-like growth factor type I receptor (IGF-IR) antibody IMC-A12 blocks translocation of the androgen receptor to the nucleus, dramatically augmenting efficacy of androgen deprivation in human prostate xenograft models. The combination of androgen deprivation with IMC-A12 is anticipated to more effectively treat cancer within the prostate, optimizing local control, while potentially eliminating micrometastatic disease. We propose to test this hypothesis in this phase II study, administering neoadjuvant androgen deprivation therapy IMC-A12 prior to radical prostatectomy for patients with clinically localized, high risk prostate cancer for 3 months.

Patients with clinically localized, and surgically resectable (cT1-T3) prostate cancer, at high risk for relapse who are candidates for radical prostatectomy will be treated with LHRH agonist and androgen receptor antagonist combined with IMC-A12, 10 mg/kg given intravenously every 14 days for 12 weeks. Patients will undergo biopsy of the prostate prior to treatment and radical prostatectomy 12 weeks after initiation of treatment.

The primary endpoint of the study is to evaluate the ability of LHRH agonist with IMC-A12 to induce a complete pathologic remission

Samples from the current study will be compared to control, untreated prostatectomy specimens from the Northwest Prostate SPORE Tissue Core and a concurrent set of specimens from patients treated with 12 weeks of combined androgen deprivation.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Neoadjuvant IMC-A12 Combined With Androgen Deprivation Prior to Prostatectomy
Study Start Date : October 2008
Primary Completion Date : August 2011
Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arm Intervention/treatment
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-A12
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.
Other Name: Cixutumumab
Drug: Bicalutamide
Bicalutamide 50 mg daily orally for 12 weeks
Drug: Goserelin
10.8 mg subcutaneous once



Primary Outcome Measures :
  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). [ Time Frame: At the time of prostatectomy after 3 months of treatment ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00769795


Locations
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
University of Washington Medical Center
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: 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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bruce Montgomery, Principal Investigator, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00769795     History of Changes
Other Study ID Numbers: 6857 (FH/UWCC ID)
NIH P50 CA097186
6857 ( Other Identifier: FHCRC/UWMC Cancer Consortium )
First Posted: October 9, 2008    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017

Keywords provided by Bruce Montgomery, Fred Hutchinson Cancer Research Center:
prostate cancer
prostatic neoplasm
androgen deprivation therapy
insulin-like growth factor receptor I
neoadjuvant
prostatectomy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Goserelin
Bicalutamide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Androgen Antagonists
Hormone Antagonists