Use of an Experimental Radiopharmaceutical (131I-MIP-1095) in Men With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Inclusion Criteria

• •Males, age ≥18 years.
• •Subjects must have histologically or cytologically confirmed adenocarcinoma of the prostate
• •Subjects must be castration resistant with evidence of progressive prostate cancer despite castrate levels of testosterone (≤ 50 ng/dL) according to the PCWG3 criteria
• •Subjects must have metastatic disease detectable by either bone scan or cross sectional imaging by CT or MRI as per the PCWG3 guidelines
• •Subjects must have progressive disease at study entry defined as 1 or more of the following 3 criteria that occurred while the subject was on androgen deprivation therapy:
• •* PSA progression defined by a minimum of two rising PSA levels with an interval of ≥1 week between each determination. Subjects who received an anti-androgen as part of their primary hormonal therapy must demonstrate progression after withdrawal. The PSA value at screening should be ≥ 2 μg/L (2 ng/mL).
• •* Soft tissue disease progression defined by RECIST 1.1
• •* Bone disease progression defined by PCWG3 with two or more new lesions on bone scan.
• •Note: For subjects enrolling on the basis of soft tissue or bone progression, the baseline scan must show progression relative to a comparison scan performed during prior therapy. If the comparison scan is not available, the baseline scan report must reference the previous scan to document progression
• •Subjects who received combined androgen blockade as their first-line hormonal therapy with an antiandrogen must have shown PSA progression after discontinuing the antiandrogen for ≥ 6 weeks prior to study treatment. No washout is needed after abiraterone or enzalutamide are discontinued. First generation antiandrogens such as bicalutamide must be withdrawn if given as first-line therapy.
• •ECOG Performance status of 0-1.
• •Adequate organ reserve as evidenced by:
• •1. neutrophil count ≥ 1500 μL
• •2. platelet count ≥ 100,000/μL
• •3. hemoglobin ≥ 9.5 g/dL
• •4. total bilirubin level ≤1.5 x ULN
• •5. AST and ALT ≤2.5 x ULN
• •6. serum amylase ≤ ULN
• •7. lipase ≤ ULN
• •8. serum creatinine ≤1.5 x ULN or calculated creatinine clearance ≥ 60 mL/min (Cockroft Gault equation)
• •9. clearance of 99mTc MAG3 within 1.5 x ULN and no evidence of obstruction on the scan.
• •Serum albumin of \> 3.0 g/dL
• •Subjects must have received, were ineligible to receive, or refused at least one cytotoxic chemotherapy and enzalutamide or abiraterone or both enzalutamide and abiraterone.
• •Subjects must agree to use a medically acceptable method of birth control (e.g., spermicide in conjunction with a barrier such as a condom) or sexual abstinence for the duration of the study, including 30 days after the last dose of study drug. Sperm donation is prohibited during the study and for 30 days after the last dose of study drug. Female partners must use hormonal or barrier contraception unless postmenopausal or abstinent.
• •Life expectancy ≥ 6 months