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

This page presents selected fields from the linked source record. It does not add a medical interpretation.

Open original source record ↗

Record identity and dates

Source

ClinicalTrials.gov

Source record ID

NCT00859781

Title field or adapter rule

{'original_value': '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', 'source_field': 'protocolSection.identificationModule.officialTitle'}

Ingested At

2026-11-07T01:02:18.857831+00:00

Published At

2023-07-19T00:00:00+00:00

Record Updated At

2026-11-05

Results Posted At

2023-07-19

Source Retrieved At

2026-11-07T01:02:18.192178+00:00

Timestamp Basis

ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

Date limitation

ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

Fields recorded by this source

protocolSection.conditionsModule.conditions

["Prostate Cancer"]

protocolSection.statusModule.lastUpdatePostDateStruct

{"date": "2026-11-05", "type": "ACTUAL"}

protocolSection.identificationModule.nctId

"NCT00859781"

protocolSection.identificationModule.officialTitle

"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"

protocolSection.statusModule.overallStatus

"ACTIVE_NOT_RECRUITING"

protocolSection.designModule.phases

["PHASE2"]

protocolSection.statusModule.resultsFirstPostDateStruct

{"date": "2023-07-19", "type": "ACTUAL"}

Study condition terms

• Prostate Cancer (protocolSection.conditionsModule.conditions)

Interventions recorded in this study

• {'armGroupLabels': ['1. 177Lu-J591 + Ketoconazole'], 'description': '177Lu-J591 70 mCi/m2 on day 29 (+/- 2 days) of treatment', 'name': '177Lu-J591', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['1. 177Lu-J591 + Ketoconazole', '2. 111In-J591 + Ketoconazole'], 'description': '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)', 'name': 'Ketoconazole', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['1. 177Lu-J591 + Ketoconazole', '2. 111In-J591 + Ketoconazole'], 'description': 'Hydrocortisone at a dose of 20 mg orally each morning, 10 mg orally each evening (total daily dose of 30 mg)', 'name': 'Hydrocortisone', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['2. 111In-J591 + Ketoconazole'], 'description': '111In-J591 at a dose of 5 mCi on day 29 (+/- 2 days) of treatment', 'name': '111In-J591', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])

An intervention appearing in a study record does not establish an effect or an approved use.

Drug names recorded in this source

• 177Lu-J591 (protocolSection.armsInterventionsModule.interventions[].name)
• Ketoconazole (protocolSection.armsInterventionsModule.interventions[].name)
• Hydrocortisone (protocolSection.armsInterventionsModule.interventions[].name)
• 111In-J591 (protocolSection.armsInterventionsModule.interventions[].name)

A recorded drug name is not by itself an indication or a condition-specific relationship.

This index keeps the source fields it imported; it may not contain the complete original record. Verify wording and context in the linked source.