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 @ 7:44 PM
Ignite Modification Date:
2025-12-24 @ 7:44 PM
NCT ID:
NCT00425503
Eligibility Criteria:
Inclusion Criteria:
* Histologic proof of prostatic adenocarcinoma without evidence of regional and/or distant metastasis, clinical stage T1, T2 or T3 with high grade disease (Gleason's grade 7 or above).
* Recent (less than or equal to 6 weeks prior to study entry) negative bone scan and CT scan of abdomen/pelvis.
* Appropriate surgical candidate for radical prostatectomy and a performance status of less than or equal to 2 (Zubrod scale).
* Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count greater than or equal to 1,500 and platelet count of greater than or equal to 100,000, adequate hepatic function with a bilirubin less than or equal to 1.5 mg % and SGPT less than 2.5x the upper limits of normal, adequate renal function defined as serum creatinine less than or equal to 2.0 mg %.
* Patients must have normal coagulation profile (PT, PTT) and no history of substantial non-iatrogenic bleeding diatheses. Use of anticoagulants is limited to local use only (for control of central line patency).
* Patients must sign an informed consent indicating that they are aware of the investigational nature of the study, in keeping with the policies of the institution.
* Patients screened and found eligible for the study, but not wanting to participate for any reason, will be followed along with the patients enrolled in the study in an effort to obtain outcome information (as historical information for design of future trials).
* No evidence of bifascicular block or active ischemia on EKG.
* Patients must have no history of congestive heart failure or previous MI.
Exclusion Criteria:
* Previous or current hormonal treatment, chemotherapy, radiation therapy, immunotherapy or other investigational status drug.
* Unable to tolerate transrectal ultrasound.
* Patients who are not appropriate surgical candidates for radical prostatectomy based on the evaluation of co-existent medical diseases and competing causes of death. Patients with uncontrolled cardiac, hepatic, renal or neurologic/psychiatric disorder are not eligible.
* Patients who are HIV positive or have chronic hepatitis B or C infections are not eligible.
* Patients on steroid medications are not eligible.
* Patients with uncontrolled and symptomatic orthostatic hypotension or uncontrolled hypertension are not eligible.
* Patients with significant arteriosclerotic disease, as defined by a previous arterial bypass, claudication limiting activity, or a history of cerebrovascular events within the last year (including TIA) are not eligible.
* Patients with diabetes mellitus requiring insulin or oral hypoglycemics for more than 5 years are not eligible.
* Patient has greater than or equal to grade 1 peripheral neuropathy within 14 days before enrollment.
* Hypersensitivity to boron, mannitol, or bortezomib.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00425503
Study Brief:
Protocol Section:
NCT00425503