Clinical trial · Interventional
Radiolabeled Monoclonal Antibody in Treating Patients With Progressive Metastatic Androgen-Independent Adenocarcinoma (Cancer) of the Prostate
A Phase II Trial Of Lu Radiolabeled Monoclonal Antibody HuJ591-GS (Lu-J591) In Patients With Metastatic Androgen-Independent Prostate Cancer
- 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)
RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or deliver radioactive tumor-killing substances to them without harming normal cells. PURPOSE: This phase II trial is studying how well radiolabeled monoclonal antibody works in treating patients with progressive metastatic androgen-independent adenocarcinoma (cancer) of the prostate.
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 |
|---|---|---|---|
| lutetium Lu 177 monoclonal antibody J591 | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Biochemical response as measured by prostate-specific antigen level at 8 weeks after treatment
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the prostate
* Metastatic disease
* Progressive disease after prior antiandrogen therapy, as evidenced by at least 1 of the following parameters:
* New osseous lesions on bone scan
* Greater than 25% increase in the sum of the products of the longest perpendicular diameters of the lesions OR the appearance of new lesions on MRI or CT scan
* Rising prostate-specific antigen (PSA) despite adequate medical or surgical castration therapy
* Consecutive increase in PSA, determined by two separate measurements taken at least 1 week apart and confirmed by a third, and if necessary, a fourth measurement
* PSA must be ≥ 5 ng/mL and ≥ 25% above the previous nadir
* Measurable or evaluable disease
* Serum testosterone ≤ 50 ng/dL
* No confluent lesions involving axial and appendicular skeleton on bone scan ("superscan")
PATIENT CHARACTERISTICS:
Age
* Over 18
Performance status
* Karnofsky 70-100%
Life expectancy
* At least 6 months
Hematopoietic
* Absolute neutrophil count ≥ 2,000/mm\^3
* Hematocrit ≥ 30%
* Hemoglobin ≥ 10 g/dL
* Platelet count ≥ 150,000/mm\^3
* No serious hematologic illness that would preclude study participation
Hepatic
* AST ≤ 2 times upper limit of normal (ULN)
* Bilirubin ≤ 1.5 times ULN
* PTT normal
* PT normal OR
* INR normal
* No serious hepatic illness that would preclude study participation
Renal
* Creatinine ≤ 2.5 mg/dL
* Calcium ≤ 11 mg/dL
* No serious renal illness that would preclude study participation
Cardiovascular
* No New York Heart Association class III or IV heart disease
* No active angina pectoris
* No prior deep vein thrombophlebitis within the past 3 months
* No other serious cardiac illness that would preclude study participation
Pulmonary
* No pulmonary embolus within the past 3 months
* No other serious respiratory illness that would preclude study participation
Other
* Fertile patients must use effective contraception
* HIV negative
* No serious CNS illness that would preclude study participation
* No active serious infection not controlled by antibiotics
* No other serious illness that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* More than 2 weeks since prior red blood cell or platelet transfusions
* More than 2 weeks since prior hematopoietic growth factors
* No prior monoclonal antibody therapy except ProstaScint®
* No other concurrent monoclonal antibody-based therapy
* No concurrent medication to support platelet count (e.g., oprelvekin)
Chemotherapy
* More than 4 weeks since prior cytotoxic chemotherapy
Endocrine therapy
* See Disease Characteristics
* Concurrent luteinizing hormone-releasing hormone (LHRH) analog allowed provided 1 of the following is true:
* Treatment is maintained during study participation
* Treatment is terminated at least 10 weeks (for 1-month depot preparations), 24 weeks (for 3-month depot preparations), or 32 weeks (for 4-month depot preparations) prior to study entry
* More than 4 weeks since prior corticosteroids
* More than 4 weeks since prior adrenal hormone inhibitors
* Concurrent low-dose prednisone (≤ 5mg/day) for adrenal insufficiency allowed
* No concurrent finasteride
Radiotherapy
* More than 4 weeks since prior radiotherapy
* No prior radiotherapy to \> 25% of skeleton
* No prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium-containing compounds (e.g., Metastron® or Quadramet®)
Surgery
* Not specified
Other
* More than 4 weeks since prior PC-SPES
* More than 4 weeks since prior investigational therapy (medications or devices)
* At least 1 week since prior aspirin and/or nonsteroidal anti-inflammatory agents possessing antiplatelet activity
* At least 1 week since prior antiplatelet medication, including the following:
* Abciximab
* Cilostazol
* Clopidogrel
* Dipyridamole
* Ticlopidine
* No concurrent anticoagulant medications (for platelet count \< 50,000/mm\^3), including the following:
* Dalteparin
* Danaparoid
* Enoxaparin
* Heparin
* Warfarin
* No other concurrent investigational therapyReferences
Publications (0)
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