I-131-1095 Radioligand Plus Enzalutamide vs Enzalutamide for mCRPC That Progressed During Abiraterone (ARROW).

Inclusion Criteria

• •1. Male ≥ 18 years of age
• •2. Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features at initial diagnosis
• •3. Castration-resistant prostate cancer, with serum testosterone ≤ 50 ng/dL at Screening
• •4. Radiographic evidence of metastatic disease prior to Randomization or up to 21 days prior to Screening
• •5. Disease progression on prior abiraterone therapy as defined by meeting at least one of the following criteria per the investigator:
• •1. PSA progression as defined by a minimum of two rising PSA levels at least 1 week apart
• •2. Soft tissue disease progression defined by RECIST 1.1
• •3. Bone disease progression defined by two or more new lesions on bone scan
• •6. Planned to receive treatment with enzalutamide
• •7. Subjects who are ineligible or choose not to receive taxane-based chemotherapy based on personal preference or physician opinion. Examples of conditions that could make a patient ineligible or refuse to receive taxane-based chemotherapy, but would allow them to still be eligible to receive I-131-1095 include the following:
• •1. Poor performance status
• •2. Prior intolerance to cytotoxic agents
• •3. History of another malignancy suspected for recurrence or metastases
• •4. Other serious medical conditions such as symptomatic peripheral neuropathy CTCAE Grade 2 or higher; or clinically significant cardiovascular disease per the Investigator or treating physician
• •8. Subjects receiving bisphosphonate therapy must have been on stable doses for at least 4 weeks prior to Randomization
• •9. ECOG performance status 0-2
• •10. If sexually active, agree to use a medically acceptable method of birth control or sexual abstinence from the time of dosing through 28 days after the last dose of I-131-1095. Female partners must use hormonal or barrier contraception unless postmenopausal or abstinent.
• •11. Estimated life expectancy of at least 6 months as determined by the Investigator.
• •12. Able and willing to provide signed informed consent and comply with protocol requirements