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

NCT00859781 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2026-04-08

Study results available
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Summary

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.

Conditions

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

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Scott T Tagawa, M.D. · Weill Medical College of Cornell University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2022-02-10
Completion
2026-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00859781 on ClinicalTrials.gov