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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

Phase 1
18 Years
Open (Enrolling)
Prostate Cancer

Thank you

Trial Information

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

This research is being done because the standard treatments for metastatic prostate cancer
that is growing despite medical or surgical therapies are not curative. Existing
treatments, such as the docetaxel used as part of this study, may work temporarily, but
unfortunately the cancer continues to grow. This test drug, 177Lu-J591, is designed to seek
out prostate cancer cells and deliver a lethal dose of radiation to the areas of cancer, but
not to normal areas. Some of the normal organs (liver, kidney and bone marrow) do receive
some radiation dose that is within the acceptable limits.

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

- 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 leukemia

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Determine the maximum tolerated dose of fractionated 177Lu-DOTA-J591 administered concurrently with three-weekly docetaxel for the treatment of patients with metastatic, castrate-resistant prostate cancer.

Outcome Time Frame:

4 weeks post last J591 dose

Safety Issue:


Principal Investigator

Scott Tagawa, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Weill Medical College of Cornell University


United States: Food and Drug Administration

Study ID:




Start Date:

May 2009

Completion Date:

May 2012

Related Keywords:

  • Prostate Cancer
  • castrate-resistant prostate cancer
  • CRPC
  • Prostatic Neoplasms



Weill Cornell Medical College New York, New York  10021
University of North Carolina Chapel Hill Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina  27599