Status:
COMPLETED
CP-675,206 With Neoadjuvant Hormone Therapy in Patients With High Risk Prostate Cancer
Lead Sponsor:
AstraZeneca
Conditions:
Prostatic Neoplasms
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
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 th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2006
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00075192
Start Date
March 1 2004
End Date
March 1 2006
Last Update
June 6 2012
Active Locations (11)
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1
Research Site
La Masa, California, United States, 91442
2
Research Site
Washington D.C., District of Columbia, United States, 20307
3
Research Site
Gallatin, Tennessee, United States, 37066
4
Research Site
Hermitage, Tennessee, United States, 37076