Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2025-12-24 @ 3:31 PM
NCT ID:
NCT00075192
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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00075192
Study Brief:
Protocol Section:
NCT00075192