Clinical trial · Interventional
Docetaxel/Prednisone Plus Fractionated 177Lu- J591 Antibody for Metastatic, Castrate-resistant Prostate Cancer
A Phase I Trial of Docetaxel/Prednisone Plus Fractionated 177Lu- J591 Anti-prostate-specific Membrane Antigen Monoclonal Antibody in Patients With Metastatic, Castrate-resistant Prostate Cancer
NCT00916123CI-TRIAL-00051923completedPhase 1ClinicalTrials.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 test the effectiveness of the experimental drug, 177Lu-J591 antibody in combination with docetaxel chemotherapy against metastatic, castrate-resistant 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 177Lu-J591 | Drug | — | UNRESOLVED |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Prednisone | Drug | Prednisone | ALIAS |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Dose Level 1
- description
- 177Lu-J591 at 20 mCi/dose
- interventionNames
- Drug: Docetaxel
- Drug: Prednisone
- Drug: 177Lu-J591
- type
- EXPERIMENTAL
- label
- Dose Level 2
- description
- 177Lu-J591 at 25 mCi/dose
- interventionNames
- Drug: Docetaxel
- Drug: Prednisone
- Drug: 177Lu-J591
- type
- EXPERIMENTAL
- label
- Dose Level 3
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Histologic diagnosis of prostate adenocarcinoma.
* Patient must have progressive metastatic prostate cancer despite adequate medical or surgical castration therapy.
* Serum testosterone \< 50 mg/ml.
* Patients who have previously received docetaxel must meet BOTH of the the following criteria:
* reason for docetaxel discontinuation must NOT have been progression of disease while receiving drug (i.e. progression of cancer must have been AFTER docetaxel discontinuation) AND
* All docetaxel-related toxicities must have resolved to \< grade 1 (with the exception of alopecia) and the pt must be eligible by other criteria
Exclusion Criteria:
* 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 ("superscan").
* Prior radiation therapy encompassing \>25% of skeleton.Prior treatment with 89Strontium or 153Samarium containing compounds (e.g. Metastron®, Quadramet®).
* Platelet count \<150,000/mm3.
* Absolute neutrophil count (ANC) \<2,000/mm3.
* Hematocrit \<30 percent or Hemoglobin \< 10 g/dL.
* Abnormal coagulation profile (PT or INR, PTT) \> 1.3 x upper limit of normal (unless on therapeutic anticoagulation).
* -Serum creatinine \>2.5 mg/dL.
* AST (SGOT) \>2.5x ULN.
* Bilirubin (total) \>1.5x ULN.
* Serum calcium \>11 mg/dL.
* Active serious infection.
* Active angina pectoris or New York Heart Association Class III-IV.
* ECOG Performance Status \>2.
* Life expectancy \<6 months.
* Deep vein thrombosis and/or pulmonary embolus within 1 month of study entry.
* Other serious illness(es) which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study.
* Prior anti-PSMA monoclonal antibody therapy with the exception of ProstaScint®.
* Prior investigational therapy within 6 weeks of treatment.
* Known history of HIV.
* Known history of myelodysplastic syndrome or leukemiaReferences
Publications (1)
- RESULTBatra JS, Niaz MJ, Whang YE, Sheikh A, Thomas C, Christos P, Vallabhajosula S, Jhanwar YS, Molina AM, Nanus DM, Osborne JR, Bander NH, Tagawa ST. Phase I trial of docetaxel plus lutetium-177-labeled anti-prostate-specific membrane antigen monoclonal antibody J591 (177Lu-J591) for metastatic castration-resistant prostate cancer. Urol Oncol. 2020 Nov;38(11):848.e9-848.e16. doi: 10.1016/j.urolonc.2020.05.028. Epub 2020 Jun 27. PMID 32600929