I-131-1095 Radioligand Plus Enzalutamide vs Enzalutamide for mCRPC That Progressed During Abirate… (NCT03939689) | Clinical Trial Compass
CompletedPhase 2
I-131-1095 Radioligand Plus Enzalutamide vs Enzalutamide for mCRPC That Progressed During Abiraterone (ARROW).
United States120 participantsStarted 2019-05-30
Plain-language summary
This clinical trial was done to show whether a radioactive drug (I-131-1095) that binds to prostate-specific membrane antigen (PSMA) is useful in treating metastatic prostate cancer that is positive for PSMA. The trial enrolled men whose PSMA-positive metastatic prostate cancer had progressed while they were taking abiraterone. During the trial, all of the men took enzalutamide (standard-of-care therapy) once a day. However, some of the men also had up to 4 doses (8 weeks apart) of I-131-1095 (in addition to taking enzalutamide once a day). At specified times during the trial, all of the men had blood tests (to measure levels of prostate-specific antigen \[PSA\]) and imaging studies (to assess tumor status). The two groups of men were then compared in several ways. The main comparison was the percentage of men in each group with at least a 50% decrease in PSA levels. Other comparisons involved the response of the tumors (as seen on imaging) and overall survival. To assess safety, the number of adverse events in both groups were also compared.
Who can participate
Age range18 Years
SexMALE
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Inclusion criteria
✓. Male ≥ 18 years of age
✓. Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features at initial diagnosis
✓. Castration-resistant prostate cancer, with serum testosterone ≤ 50 ng/dL at Screening
✓. Radiographic evidence of metastatic disease prior to Randomization or up to 21 days prior to Screening
✓. Disease progression on prior abiraterone therapy as defined by meeting at least one of the following criteria per the investigator:
✓. PSA progression as defined by a minimum of two rising PSA levels at least 1 week apart
✓. Soft tissue disease progression defined by RECIST 1.1
✓. Bone disease progression defined by two or more new lesions on bone scan
Exclusion criteria
✕. Received any anti-tumor therapy within 4 weeks of Randomization, with the exception of abiraterone, GnRH therapy and non-radioactive bone-targeted agents