Expired Study
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Rochester, Minnesota 55905


Purpose:

A total of 108 males with advanced prostate cancer will be enrolled into this study. Patients must have undergone prostate cancer staging within 180 days of enrollment. 54 patients will be randomized to receive hormone therapy alone and 54 patients will be randomized to receive hormone therapy plus the MDX-010 therapy.


Study summary:

This trial has been designed to ensure the capture of both treatment mechanism-specific data as well as clinically meaningful data within a relatively compressed study interval. Thus, this trial is constructed around a single inductive short-term cycle of AA therapy.


Criteria:

Inclusion Criteria: - Histologically confirmed adenocarcinoma of the prostate staged within 180 days of study enrollment, stage with or without metastatic disease, with the exclusion of central nervous system metastases; includes post radical prostatectomy patients with a rising PSA. - An initial PSA greater than 4.0 using the Hybritech Assay. For those participants who have received hormone therapy less than or equal to 21 days, a documented PSA of greater than or equal to 4.0 prior to initiation of hormone therapy is acceptable. For those participants who are post radical prostatectomy, a rising PSA is acceptable. - Adequate organ function defined as: WBC greater than 3,000; platelets greater than 75,000; total bilirubin less than 1.5mg; transaminases less than 2.5 times upper limit of normal; serum creatinine less than 2.0 mg or calculated creatinine clearance greater than 60 mL. All values must be obtained 14 days prior to study entry. - ECOG performance status of 0 2. - Patients must be 18 years of age at the time of study entry and able to understand and sign informed consent. Exclusion Criteria: - Underlying other serious medical condition which, in the opinion of the investigator, precludes study participation. This includes immuno-suppressive disease such as AIDS or autoimmune disorders such as multiple sclerosis or lupus. - Patients not recovered from major infections and/or surgical procedures. - Prior hormonal therapy greater than 21 days prior to enrollment, including estrogens, LH/RH agonists, antiandrogens, or 5-reductase inhibitors. - Recent less than 3 months of informed consent usage of immuno suppressive medications including steroids, Immuran, Cyclosporin. Topical or inhalational steroid use is permissible. - For participants who elect to undergo the baseline transrectal needle biopsy of the prostate, current usage of systemic anticoagulation therapy, i.e. heparin or coumadin or inability to discontinue aspirin, aspirin-containing products or ibuprofen for seven days prior to the prostate biopsies required for this study. - Prior systemic chemotherapy. - Prior radiation therapy to the prostate - Concurrent malignancy, except for adequately treated basal cell or squamous cell skin cancer. - Prior malignancy, unless the patient has been cancer free for five years or more. - Uncontrolled underlying medical or psychiatric illness, or serious active infections. - Patient unwilling to complete all required follow-up visits.


NCT ID:

NCT00170157


Primary Contact:

Principal Investigator
Eugene D. Kwon, M.D.
Mayo Clinic


Backup Contact:

N/A


Location Contact:

Rochester, Minnesota 55905
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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