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

AstraZeneca

Status and phase

Completed

Phase 2

Phase 1

Conditions

Prostatic Neoplasms

Treatments

Drug: leuprolide acetate and bicalutamide

Drug: CP-675,206 and leuprolide acetate and bicalutamide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00075192

A3671004

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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