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Active Not Recruiting NCT00859781

177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With Prostate Cancer

Conditions: Prostate Cancer

Sex: Male
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 55
Sponsor: Weill Medical College of Cornell University

Location: Cedars Sinai Los Angeles California

Summary

The purpose of this study is to test the effectiveness of the experimental drug, 177Lu-J591 in combination with ketoconazole and hydrocortisone against prostate cancer.

Eligibility Criteria

Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the prostate previously treated with surgery and/or radiotherapy. * Biochemical progression (rising PSA) after medical or surgical castration * High risk of systemic progression defined as: 1. Rising PSA as defined above and either: 2. Absolute PSA \> 20 ng/mL AND/OR 3. PSA doubling time \< 8 months * No evidence of local recurrence or distant metastases * Age \>18 years. * Serum testosterone \< 50 ng/ml * Patients capable of fathering children must agree to use an effective method of contraception for the duration of the trial. * Subjects on bisphosphonate therapy must be on a stable dose and must have started therapy \> 4 weeks prior to protocol therapy. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Use of red blood cell or platelet transfusions within 4 weeks of treatment * Use of hematopoietic growth factors within 4 weeks of treatment * Prior cytotoxic chemotherapy and/or radiation therapy within 4 weeks of treatment * Prior radiation therapy encompassing \>25% of skeleton (see Appendix C) * Prior treatment with 89Strontium or 153Samarium containing compounds (e.g. Metastron®, Quadramet®) * Platelet count \2x ULN * Bilirubin (total) \>1.5x ULN; subjects with Gilbert's syndrome will be allowed if direct bilirubin is within institutional normal limits * Active serious infection * Active angina pectoris or NY Heart Association Class III-IV * ECOG Performance Status \> 2 * Life expectancy \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT00859781). StuddyBuddy aggregates publicly available trial information.