Radioimmunotherapy in Prostate Cancer Using 177Lu-J591 Antibody

Inclusion

• Hematocrit \> 27% or Hemoglobin \> 9 g/dL without blood transfusion dependency
• ECOG Performance Status \> 2
• progressive tumor lesions on CT or MRI and/or
• Serum testosterone \< 50 ng/mlExclusion Criteria
• Known history of HIV
• Prior cytotoxic chemotherapy and/or radiation therapy within 4 weeks of treatment.
• For subjects who have not undergone surgical orchiectomy, LHRH agonist or antagonist therapy must me maintained for the duration of this study
• Progressive, castrate metastatic carcinoma of the prostate defined by presence of metastatic disease on imaging and:
• AST \> 2x ULN
• CNS metastasis
• Patients of child bearing potential must agree to use an effective method of contraception
• History of seizure and/or stroke within past 6 months
• Life expectancy \< 6 months
• Patient must have progressed following discontinuation of anti-androgen therapy, if received
• Prior radiation therapy encompassing \>25% of expected red marrow distribution.
• Prior treatment with 89Strontium (Metastron®) or 153Samarium (Quadramet®)
• rising PSA
• Inclusion Criteria
• Other investigational therapy within 4 weeks of treatment
• Serious active infection (as assessed by investigator)
• Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study
• Normal coagulation profile (defined as PT or INR and PTT \< 1.3x ULN), unless on a stable anticoagulation regimen
• Serum creatinine \> 2x ULN
• Prior corticosteroids and/or adrenal hormone inhibitors within 4 weeks of treatment, except for low dose maintenance prednisone or hydrocortisone (i.e. for adrenal insufficienty) on a stable dose at the investigator's discretion
• Bilirubin (total) \> 1.5x ULN; subjects with Gilbert's syndrome will be allowed if direct bilirubin is within institutional normal limits
• Histologic diagnosis (recent or remote) of prostate adenocarcinoma
• Rising PSA on 3 serial determinations over a period of greater than 2 weeks. An increase in PSA must be determined by two separate measurements taken at least one week apart and confirmed by a third and if necessary, a fourth measurement. If the third measurement is not greater than the second, then a fourth measurement must be taken. The fourth measurement must be greater than the second measurement for the patients to be eligible for enrollment in the study. The minimum final PSA must be \> 2.
• new osseus lesions on bone scan and/or
• Active angina pectoris or NY Heart Association Class III-IV
• Absolute neutrophil count (ANC) ≥ 2,000/mm3
• Prior treatment with monoclonal Ab J591 labeled with therapeutic doses of 177Lu or 90Y
• Platelet count \> 150,000/mm3

Exclusion

Exclusion criteria not yet provided.