Clinical trial · Interventional
Treatment With Radiolabeled Monoclonal Antibody HuJ591-GS (177Lu-J591) in Patients With Metastatic Prostate Cancer
A Phase 2 Trial of 177Lu Radiolabeled Monoclonal Antibody HuJ591-GS (177Lu-J591) in Patients With Metastatic Androgen-Independent Prostate Cancer
NCT00195039CI-TRIAL-00029792completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu -J591) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- All patients
- description
- 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.
- interventionNames
- Drug: 177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu -J591)
Primary outcomes (2)
- measure
- Define the PSA Response Rate.
- timeFrame
- At baseline, Day 1, 29, 43, 57, 85, week 18, week 24 & every 12 weeks
- description
- PSA response rate corresponds to change form baseline in PSA at any of the time points specified.
- measure
- Define the Measurable Disease Response Rate.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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 \< 50 ng/ml Exclusion Criteria: * Use of corticosteroids and/or adrenal hormone inhibitors within 4 weeks of treatment. * Use of PC-SPES within 4 weeks of treatment. * Use of red blood cell or platelet transfusions within 4 weeks of treatment. * Use of hematopoietic growth factors within 4 weeks of treatment. * Prior cytotoxic chemotherapy and/or radiation therapy within 4 weeks of treatment. * Bone scan demonstrating confluent lesions involving both axial and appendicular skeleton. * Prior radiation therapy encompassing \>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
References
Publications (3)
- RESULTS.T. Tagawa; M.I. Milowsky; M. J. Morris; S. Vallabhajosula; S. Goldsmith; D. Matulich; J. Kaplan; F. Berger; H. I. Scher; N. H. Bander; D. M. Nanus. Phase II trial of 177Lutetium radiolabeled anti-prostate-specific membrane antigen (PSMA) monoclonal antibody J591 in patients with metastatic castrate-resistant prostate cancer. J Clin Oncol 26: 2008 (May 20 suppl; abstr 5140)
- RESULTTagawa ST, Milowsky MI, Morris M, Vallabhajosula S, Christos P, Akhtar NH, Osborne J, Goldsmith SJ, Larson S, Taskar NP, Scher HI, Bander NH, Nanus DM. Phase II study of Lutetium-177-labeled anti-prostate-specific membrane antigen monoclonal antibody J591 for metastatic castration-resistant prostate cancer. Clin Cancer Res. 2013 Sep 15;19(18):5182-91. doi: 10.1158/1078-0432.CCR-13-0231. Epub 2013 May 28. PMID 23714732
- DERIVEDVlachostergios PJ, Niaz MJ, Skafida M, Mosallaie SA, Thomas C, Christos PJ, Osborne JR, Molina AM, Nanus DM, Bander NH, Tagawa ST. Imaging expression of prostate-specific membrane antigen and response to PSMA-targeted beta-emitting radionuclide therapies in metastatic castration-resistant prostate cancer. Prostate. 2021 Apr;81(5):279-285. doi: 10.1002/pros.24104. Epub 2021 Jan 19. PMID 33465252