A Phase I Pilot Study Comparing 123I MIP 1072 Versus 111In Capromab Pendetide in Subjects With Metastatic Prostate Cancer

Inclusion Criteria

• •Subjects must meet all of the following criteria to be enrolled in this study.
• •1. Male aged 18 years or older
• •2. Signed written informed consent and willingness to comply with protocol requirements
• •3. Histologic diagnosis of prostate cancer by validated history and/or biopsy of the prostate or of a metastatic lesion.
• •4. Evidence of metastatic disease as documented by an abnormal bone scan and CT scan or MRI plus:
• •* Castration/anti androgen therapy naïve/sensitive:
• •1. Gleason Score ≥ 7 and PSA ≥ 2.0 ng/mL with history of prostatectomy or primary radiation therapy of the prostate gland and prior undetectable PSA or; PSA \> 10.0 ng/mL if intact prostate, or
• •2. Gleason score ≤ 6 and PSA is ≥ 20 ng/mL, or
• •3. Gleason Score ≥ 8 and any doubling of PSA, or PSA \> 0.5 ng/mL, or
• •4. Clinical Stage 3 and Gleason Score ≥ 8
• •If on anti androgen therapy, must have initiated therapy at least 4 weeks prior to treatment.
• •* Castration/anti androgen therapy resistant:
• •1. Patients must have current or historical evidence of disease progression concomitant with surgical (orchiectomy) or medical castration (LHRH analogue); anti androgen withdrawal (4 weeks for flutamide and 6 weeks for nilutamide or bicalutamide) is necessary only for patients on anti androgens who have demonstrated a \> 3 month duration of beneficial response to anti androgens; progression is demonstrated by any of the following:
• •I. PSA progression: 2 serial rising PSA determinations at least 14 days apart over the PSA nadir, with the last measurement ≥ 2 ng/mL
• •II. Progression of measurable disease, or progression of non measurable disease as defined by:
• •i. Soft tissue disease: The appearance of one or more new lesions, and/or unequivocal worsening of non measurable disease when compared to imaging studies acquired during castration therapy or against the precastration studies if there was no response, or ii. Bone disease: Appearance of two or more new areas of abnormal uptake on bone scan when compared to imaging studies acquired during castration therapy or against the pre castration studies if there was no response.
• •III. Increased uptake of pre existing lesions on bone scan does not constitute progression.
• •IV. Testosterone ≤ 50 ng/dL achieved via medical or surgical castration.
• •5. Male subjects who are fertile agree to use an acceptable form of birth control, defined as abstinence, barrier or other acceptable, effective contraceptive method throughout the study period. A second form of barrier birth control must be utilized if a subject's partner is using oral contraception until at least seven days after the last injection.
• •6. Karnofsky performance is ≥ 50
• •7. Adequate hematologic, renal and liver function:
• •* WBC ≥ 2.0×103/mm3 (ANC \> 1.0 x 103 mm3)
• •* Platelet count ≥ 75×103/mm3
• •* Hemoglobin ≥ 9.0 g/dL
• •* Creatinine ≤ 2.5 mg/dL
• •* Total bilirubin ≤ 2x ULN
• •* AST, ALT ≤ 5x ULN