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Clinical Trial · NCT00859781
177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With Prostate Cancer
Overview
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.
Sponsor
Weill Medical College of Cornell University
Phase
Phase 2
Contacts
Scott T Tagawa, M.D. (PRINCIPAL_INVESTIGATOR)
ClinicalTrials.gov
NCT00859781Eligibility
Inclusion
- Rising PSA as defined above and either:
- Histologically or cytologically confirmed adenocarcinoma of the prostate previously treated with surgery and/or radiotherapy.
- No evidence of local recurrence or distant metastases
- High risk of systemic progression defined as:
- PSA doubling time \< 8 months
- Biochemical progression (rising PSA) after medical or surgical castration
- Absolute PSA \> 20 ng/mL AND/OR
Exclusion
- Adrenal hormone inhibitors (other than ketoconazole) within 4 weeks prior to study enrollment
- Prior use of ketoconazole for the purposes of prostate cancer therapy for greater than 1 month
- Finasteride (Propecia® or Proscar®) or dutasteride (Avodart®) within 4 weeks of enrollment
- Platelet count \<150,000/mm3 or known primary qualitative platelet disorder
- Prior cytotoxic chemotherapy and/or radiation therapy within 4 weeks of treatment
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