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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00859781 | 177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With Prostate Cancer | PHASE2 | ACTIVE NOT_RECRUITING | 55 | — | — | Jun 1, 2009 | Sep 1, 2026 | Apr 8, 2026 | 9 | United States |
Subjects will perform a CT and/or MRI scan of the abdomen and pelvis, chest x-ray or CT scan of the chest and bone scan to determine the proportion of participants free of radiographically evident metastases from baseline to 18 months after study drug administration.
| Arm | Type | Description |
|---|---|---|
| 1. 177Lu-J591 + Ketoconazole | EXPERIMENTAL | Ketoconazole 400 mg 3 times a day plus hydrocortisone 20 mg AM, 10 mg PM x 4 weeks followed by 177Lu-J591 Infusion, continue ketoconazole and hydrocortisone |
| 2. 111In-J591 + Ketoconazole | PLACEBO_COMPARATOR | Ketoconazole 400 mg 3 times a day plus hydrocortisone 20 mg AM, 10 mg PM x 4 weeks followed by 111In-J591 (placebo) Infusion, continue ketoconazole and hydrocortisone |
| Name | Type | Description |
|---|---|---|
| 177Lu-J591 | DRUG | 177Lu-J591 70 mCi/m2 on day 29 (+/- 2 days) of treatment |
| Ketoconazole | DRUG | Ketoconazole at a dose of 400 mg (two 200 mg tabs) to be taken orally (preferably on an empty stomach) three times per day (total daily dose of 1200 mg) |
| Hydrocortisone | DRUG | Hydrocortisone at a dose of 20 mg orally each morning, 10 mg orally each evening (total daily dose of 30 mg) |
| 111In-J591 | DRUG | 111In-J591 at a dose of 5 mCi on day 29 (+/- 2 days) of treatment |
Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the prostate previously treated with surgery and/or radiotherapy. * Biochemical progression (rising PSA) after medical or surgical castration * High risk of systemic progression defined as: 1. Rising PSA as defined...