Prostatic Neoplasms
Conditions
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.
Interventions
DRUGCP-675,206 and leuprolide acetate and bicalutamide
DRUGleuprolide acetate and bicalutamide
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United States
Outcome results
None listed