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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

June 30, 2009

Primary Completion Date

February 10, 2022

Study Completion Date

May 31, 2026

Conditions
Prostate Cancer
Interventions
DRUG

177Lu-J591

177Lu-J591 70 mCi/m2 on day 29 (+/- 2 days) of treatment

DRUG

Ketoconazole

Ketoconazole at a dose of 400 mg (two 200 mg tabs) to be taken orally (preferably on an empty stomach) three times per day (total daily dose of 1200 mg)

DRUG

Hydrocortisone

Hydrocortisone at a dose of 20 mg orally each morning, 10 mg orally each evening (total daily dose of 30 mg)

DRUG

111In-J591

111In-J591 at a dose of 5 mCi on day 29 (+/- 2 days) of treatment

Trial Locations (9)

10021

Weill Cornell Medical College, New York

15232

UPMC Hillman Cancer Center, Pittsburgh

20007

Georgetown University Medical Center, Washington D.C.

46202

Indiana University Melvin and Bren Simon Cancer Center, Indianapolis

52242

University of Iowa Hospitals and Clinics, Iowa City

66205

The University of Kansas Cancer Center, Westwood

84108

University of Utah, Salt Lake City

90048

Cedars Sinai, Los Angeles

90089

USC/Norris Comprehensive cancer center, Los Angeles

All Listed Sponsors
collaborator

United States Department of Defense

FED

lead

Weill Medical College of Cornell University

OTHER

NCT00859781 - 177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With Prostate Cancer | Biotech Hunter | Biotech Hunter