Phase 2
Completed N=47
Treatment With Radiolabeled Monoclonal Antibody HuJ591-GS (177Lu-J591) in Patients With Metastatic Prostate Cancer
Source: ClinicalTrials.gov NCT00195039 ↗Enrolled (actual)
47
Serious AEs
19.2%
Results posted
Oct 2017
Primary outcomePrimary: Define the PSA Response Rate. — 5; 17; 25 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Define the PSA Response Rate. |
5; 17; 25 | — |
| PRIMARY Define the Measurable Disease Response Rate. |
1; 8; 2; 1 | — |
| SECONDARY Define the Duration of Biochemical PSA and/or Measurable Disease Response. |
22.2; 11.4 | — |
| SECONDARY Define the Toxicity of 177Lu-J591 Given as Single Dose. |
6; 0; 0; 41; 11; 0 | — |
| SECONDARY Define the Incidence of Human Anti-J591 Antibody (HAHA) Response. |
— | — |
| SECONDARY Number of Participants With Hematological Toxicity Relative to Bone Marrow Involvement (Bone Scan Index). |
— | — |
| SECONDARY Assess the Survival Rate of Patients Following Treatment. |
17.6 | — |
| SECONDARY Number of Participants With Targeting of 177Lu-J591 to Known Tumor Sites. |
44 | — |
Eligibility Criteria
Inclusion Criteria
- Histologic diagnosis of prostate adenocarcinoma.
- Metastatic prostate cancer progressive on imaging studies and/or rising PSA despite adequate medical or surgical castration therapy.
- Progressed following discontinuation of anti-androgen therapy, if received.
- Serum testosterone 25% of skeleton.
- Prior treatment with 89Strontium or 153Samarium containing compounds (e.g. Metastron®, Quadramet®).
- Active angina pectoris or NY Heart Association Class III-IV.
- History of deep vein thrombophlebitis and/or pulmonary embolus within 3 months of study entry.
- Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study.
- Prior monoclonal antibody therapy with the exception of ProstaScint®
- Prior investigational therapy (medications or devices) within 6 weeks of treatment.
- Known history of HIV
Data sourced from ClinicalTrials.gov (NCT00195039). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.