Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03939689 | I-131-1095 Radioligand Plus Enzalutamide vs Enzalutamide for mCRPC That Progressed During Abiraterone (ARROW). | PHASE2 | COMPLETED | 120 | — | — | May 30, 2019 | Sep 24, 2024 | Oct 14, 2025 | 27 | United States, Canada |
The percentage of participants with a PSA response according to PCWG3 criteria. PCWG3 defines PSA response as the first occurrence of a 50 percent or more decline in PSA from baseline, confirmed by a second measurement at least 3 weeks later.
| Arm | Type | Description |
|---|---|---|
| Enzalutamide | ACTIVE_COMPARATOR | Participants received the label dosage of enzalutamide once daily for up to 53 weeks. |
| I-131-1095 in combination with enzalutamide | EXPERIMENTAL | Participants received up to 4 (8-week) cycles of I-131-1095: 100 mCi for the first dose. Subsequent dose(s) were reduced to 75 mCi for participants experiencing any of the dose-limiting toxicities. The third and fourth therapeutic doses could be reduced to 75 mCi on the basis of dosimetry assessment after administration of 10 mCi of I-131-1095 prior to the third dosing cycle. Participants also received the label dosage of enzalutamide once daily for up to 53 weeks. |
| Name | Type | Description |
|---|---|---|
| I-131-1095 | DRUG | Participants received up to 4 (8-week) cycles of I-131-1095: 100 mCi for the first dose. Subsequent dose(s) were reduced to 75 mCi for participants experiencing any dose-limiting toxicities. The third and fourth therapeutic doses could be reduced to 75 mCi on the basis of dosimetry assessment after administration of 10 mCi of I-131-1095 prior to the third dosing cycle. Participants also received the label dosage of enzalutamide once daily for up to 53 weeks. |
| Enzalutamide | DRUG | Participants received the label dosage of enzalutamide once daily for up to 53 weeks. |
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. Ra...