Clinical trial NCT00075192: CP-675,206 With Neoadjuvant Hormone Therapy in Patients With High Risk Prostate Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Prostatic Neoplasms
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2004-01-07
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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 outcomes:
measure: 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
Other outcomes:
Locations:
city: La Masa
country: United States
facility: Research Site
state: California
city: Washington
country: United States
facility: Research Site
state: District of Columbia
city: Gallatin
country: United States
facility: Research Site
state: Tennessee
city: Hermitage
country: United States
facility: Research Site
state: Tennessee
city: Lebanon
country: United States
facility: Research Site
state: Tennessee
city: Murfreesboro
country: United States
facility: Research Site
state: Tennessee
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Smyrna
country: United States
facility: Research Site
state: Tennessee
Study officials:
References: