At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed prostate adenocarcinoma
- ✓Metastatic disease with evidence of progression on imaging and/or rising PSA on castration therapy
- ✓Progression after anti-androgen therapy discontinuation (if previously received)
- ✓Serum testosterone maintained below 50 ng/ml
- ✕Corticosteroids or adrenal hormone inhibitors within 4 weeks of treatment
- ✕PC-SPES herbal supplement within 4 weeks of treatment
- ✕Red blood cell or platelet transfusions within 4 weeks of treatment
- ✕Hematopoietic growth factors within 4 weeks of treatment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Trial of 177Lu Radiolabeled Monoclonal Antibody HuJ591-GS (177Lu-J591) in Patients With Metastatic Androgen-Independent Prostate Cancer
In Brief
A Phase 2 clinical trial evaluating 177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu -J591) for Prostate Cancer. Completed, enrolled 47 participants across 1 site.
Detailed Summary
The purpose of this study is to find out how effective 177Lu -J591 is in the treatment of patients with metastatic, androgen-independent prostate cancer.
Study Details
Timeline
Interventions
Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated ("naked") J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.