Gender
Male
Age Group
18 Years and up
Accepting Healthy Volunteers
No
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
Exclusion Criteria:
1. Received any anti-tumor therapy within 4 weeks of Randomization, with the exception of
abiraterone, GnRH therapy and non-radioactive bone-targeted agents
2. Received prior chemotherapy for castration-resistant prostate cancer
3. Superscan as evidenced on baseline bone scan
4. Treatment with Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223 within
6 months prior to Randomization
5. Prior hemi-body irradiation
6. Prior PSMA-targeted radioligand therapy
7. Major surgery within 4 weeks of Randomization
8. Impaired organ function as evidenced by the following laboratory values at Screening:
1. Absolute neutrophil count < 1500 μL
2. Platelet count < 100,000/μL
3. Hemoglobin < 9.5 g/dL
4. Albumin < 3.0 g/dL (30 g/L)
5. Total bilirubin > 2 x ULN unless in instances of known or suspected Gilbert's
disease
6. AST or ALT > 2.5 x ULN
7. Calculated creatinine clearance (CrCL) < 30 mL/min (Cockroft-Gault equation), or
currently on renal dialysis.
9. QT interval corrected for heart rate (QTc) > 470 msec
10. Previous use of enzalutamide for more than 7 days prior to consent
11. Planned initiation of alternative therapy for prostate cancer, investigational
therapy, or participation in clinical trials during the study
12. History or risk of seizure (i.e., clinically significant neurological disorder) or any
other condition that contraindicates treatment with enzalutamide
13. Gastrointestinal disorder affecting absorption of oral medications
14. Known or suspected brain metastasis or active leptomeningeal disease
15. Active malignancy other than prostate cancer, with the exception of curatively treated
non-melanoma skin cancer, carcinoma in situ, or non-muscle invasive bladder/urothelial
cancer
16. Subjects with any medical condition or other circumstances that, in the opinion of the
investigator, compromise obtaining reliable data, achieving study objectives, or
completing the study.
