NCT00075192

Brief Summary

This is a multi-center, open label, randomized study. Patients will be randomized to one of the following arms with an allocation ratio of 3:1, respectively: Arm A: CP-675,206 + neoadjuvant hormone therapy (NHT) OR Arm B: neoadjuvant hormone therapy. After randomization, patients will receive study treatment for three cycles (one cycle is defined as 28 days). After completion of three cycles, patients will undergo a prostatectomy and pathology assessments will be completed at a central laboratory, the Armed Forces Institute of Pathology (AFIP) in Washington, DC.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2004

Typical duration for phase_1

Geographic Reach
1 country

11 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

First Submitted

Initial submission to the registry

January 5, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2004

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2004

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

June 6, 2012

Status Verified

June 1, 2012

First QC Date

January 5, 2004

Last Update Submit

June 5, 2012

Conditions

Prostatic Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Assess safety of combination therapy and effectiveness as assessed by pathological response after 3 months of treatment follow for disease status for a maximum of 24 months

Secondary Outcomes (1)

  • assess Pk during treatment monitor for human anti-human antibodies at the end of the study explore genetic influences on safety and/or immune response

Interventions

CP-675,206 and leuprolide acetate and bicalutamideDRUG
leuprolide acetate and bicalutamideDRUG

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed adenocarcinoma of the prostate, previously untreated
  • Potential candidate for radical prostatectomy on the basis of the patient's general medical condition, performance status, and life expectancy
  • Potential candidate for NHT prior to prostatectomy, including high or intermediate risk of recurrence, based on an estimated risk of biochemical recurrence: High risk category: PSA \>20 or Gleason score 8 or cT2c/cT3 OR Intermediate risk category: PSA \>10 and d20 or Gleason score 7 or cT2b
  • No evidence of metastatic disease by physical examination, bone scan, and computed tomography, or MRI, of the abdomen and pelvis
  • Age \> 18 years
  • ECOG performance status 0-1
  • Adequate bone marrow, hepatic, and renal function determined within 2 weeks prior to starting therapy
  • Availability of prostatectomy specimen for histological analysis at the Armed Forces Institute of Pathology

You may not qualify if:

  • Prior hormone therapy, radiation, chemotherapy, or immunologic therapy for prostate cancer
  • History of, or significant risk for, chronic inflammatory or autoimmune disease
  • Potential requirement for systemic corticosteroids before surgery based on prior history
  • History of autoimmune colitis or chronic GI conditions associated with diarrhea or bleeding, or current acute colitis of any origin
  • Any serious uncontrolled medical disorder or active infection which would impair ability to receive study treatment and subsequent prostatectomy
  • Coexisting malignancies except basal or squamous cell carcinoma of the skin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Research Site

La Masa, California, 91442, United States

Location

Research Site

Washington D.C., District of Columbia, 20307, United States

Location

Research Site

Gallatin, Tennessee, 37066, United States

Location

Research Site

Hermitage, Tennessee, 37076, United States

Location

Research Site

Lebanon, Tennessee, 37087, United States

Location

Research Site

Murfreesboro, Tennessee, 37130, United States

Location

Research Site

Nashville, Tennessee, 37203, United States

Location

Research Site

Nashville, Tennessee, 37205, United States

Location

Research Site

Nashville, Tennessee, 37207, United States

Location

Research Site

Nashville, Tennessee, 37211, United States

Location

Research Site

Smyrna, Tennessee, 37167, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

tremelimumabLeuprolidebicalutamide

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 Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2004

First Posted

January 7, 2004

Study Start

March 1, 2004

Study Completion

March 1, 2006

Last Updated

June 6, 2012

Record last verified: 2012-06

Locations

US(11)