A multicenter randomized controlled phase 2 study: Efficacy and safety of I-131-1095 radiotherapy in combination with enzalutamide in metastatic castration-resistant prostate cancer (mCRPC) patients who are 18F-DCFPyL prostate specific membrane antigen (PSMA)-avid chemotherapy-na ve and progressed on abiraterone (ARROW)
Recruiting
99 years or below
All
Phase
2
15 participants needed
1 Location
Brief description of study
A multicenter, open label, randomized phase 2 study of I-131-1095 radiotherapy (less than or equal to 100 mCi/dose) every 8 weeks for up to 4 doses in combination with enzalutamide compared to enzalutamide alone in patients with progressive mCRPC. Patients must have documented progression on abiraterone and be indicated for treatment with enzalutamide. Patients must not have had prior treatment with taxane based chemotherapy and must be ineligible or refuse to receive chemotherapy at the time of consent. Approximately 120 subjects at approximately 25 sites in the US and Canada will be centrally randomized in a 2:1 ratio (80 subjects receive I-131-1095 plus enzalutamide, 40 subjects receive enzalutamide along. Subjects will undergo PSMA imaging with 18F-DCFPyL PET/CT as part of the screening to confirm high PSMA expression.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Medical Research
-
Age: 99 years or below
-
Gender: All
Updated on
14 Oct 2020.
Study ID: 834060
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