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

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: January 5, 2004
Last updated: June 5, 2012
Last verified: June 2012

January 5, 2004
June 5, 2012
March 2004
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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
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Complete list of historical versions of study NCT00075192 on Archive Site
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
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CP-675,206 With Neoadjuvant Hormone Therapy in Patients With High Risk Prostate Cancer
A Phase 1, Open Label, Non-Randomized, Dose Escalation Study to Evaluate the Safety of CP-675,206 in Combination With Neoadjuvant Androgen Ablation and a Phase 2, Open Label, Randomized Study to Evaluate the Efficacy of CP-675,206 in Combination With Neoadjuvant Androgen Ablation and Androgen Ablation Alone in Patients With High Risk Prostate Cancer
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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Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostatic Neoplasms
  • Drug: CP-675,206 and leuprolide acetate and bicalutamide
  • Drug: leuprolide acetate and bicalutamide
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
March 2006
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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
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP