CP-675,206 With Neoadjuvant Hormone Therapy in Patients With High Risk Prostate Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2006-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Prostatic Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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CP-675,206 and leuprolide acetate and bicalutamide

Intervention Type DRUG

leuprolide acetate and bicalutamide

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No