CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 55 enrolled
Drug / intervention
177Lu-J591 +3 moredrug
Likely dose
Ketoconazole 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00859781
NCT00859781Phase 2Active
CompareCT.gov

A Randomized Phase 2 Trial of 177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With High-Risk Castrate Biochemically Relapsed Prostate Cancer After Local Therapy

Weill Medical College of Cornell University·interventional·Posted Mar 11, 2009·Updated Apr 8, 2026

In Brief

A Phase 2 clinical trial evaluating 177Lu-J591, Ketoconazole, and 2 other interventions for Prostate Cancer. Active but no longer recruiting, targeting 55 participants across 9 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
CollaboratorsUnited States Department of Defense

Timeline

Phase 2Active
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 11, 2009
Enrollment StartJun 1, 2009
Primary CompletionFeb 10, 2022
Study CompletionSep 1, 2026
TodayJul 2, 2026
Enrollment to primary: 12.7 yearsPosted 17.3 years ago

Interventions

177Lu-J591drug

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

Ketoconazoledrug

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)

Hydrocortisonedrug

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

111In-J591drug

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