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

Phase 1

Completed

• Conditions: Prostatic Neoplasms

• Registration Number: NCT00075192
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2004-01-05
• Study First Submitted QC: 2004-01-06
• Study First Posted: 2004-01-07
• Study Start: 2004-03
• Study Completion: 2006-03
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-05
• Last Update Posted: 2012-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇺🇸 Smyrna, Tennessee, United States