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.
- 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.
- 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.
Study participants would be randomized to receive hormone therapy alone or hormone therapy together with MDX-010. Those randomized to the hormone therapy alone would be seen monthly for 18 months. Those randomized to the hormone therapy and MDX-010 treatment group would be seen weekly for four weeks and then monthly up to 18 months.
You would be in the study for at least 18 months.
Last updated: 03/15/2012
NCT ID: NCT00170157