XCancer

177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With Prostate Cancer

Description:

The purpose of this study is to test the effectiveness of the experimental drug, 177Lu-J591 in combination with ketoconazole and hydrocortisone against prostate cancer.

Sponsor:

Weill Medical College of Cornell University

Phase:

Phase 2

Contacts:

Scott T Tagawa, M.D. (PRINCIPAL_INVESTIGATOR)

Government Study Link:

NCT00859781 - Click here to see study on

ClinicalTrials.gov

Inclusion
  • Rising PSA as defined above and either:
  • Histologically or cytologically confirmed adenocarcinoma of the prostate previously treated with surgery and/or radiotherapy.
  • No evidence of local recurrence or distant metastases
  • High risk of systemic progression defined as:
  • PSA doubling time \< 8 months
  • Biochemical progression (rising PSA) after medical or surgical castration
  • Absolute PSA \> 20 ng/mL AND/OR
Exclusion
  • Adrenal hormone inhibitors (other than ketoconazole) within 4 weeks prior to study enrollment
  • Prior use of ketoconazole for the purposes of prostate cancer therapy for greater than 1 month
  • Finasteride (Propecia® or Proscar®) or dutasteride (Avodart®) within 4 weeks of enrollment
  • Platelet count \<150,000/mm3 or known primary qualitative platelet disorder
  • Prior cytotoxic chemotherapy and/or radiation therapy within 4 weeks of treatment