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Monoclonal Antibodies

177Lu-J591 + Ketoconazole for Prostate Cancer

Phase 2

Waitlist Available

Led By Scott T Tagawa, M.D.

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically confirmed adenocarcinoma of the prostate previously treated with surgery and/or radiotherapy

Biochemical progression (rising PSA) after medical or surgical castration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up collected at screening, v2, v3, v5, v9 then every 4 weeks till psa progression or end of study at approximately 100 months

Awards & highlights

Study Summary

This trial tests a new drug to see if it's effective against prostate cancer when used with ketoconazole and hydrocortisone.

Who is the study for?

Men over 18 with advanced prostate cancer that's worsened after surgery or radiotherapy can join. They must have a rising PSA level, no signs of the cancer spreading significantly, and low testosterone. Participants should not be at high risk of other serious illnesses and agree to use contraception if they can father children.Check my eligibility

What is being tested?

The trial is testing an experimental drug called 177Lu-J591 combined with ketoconazole and hydrocortisone on prostate cancer patients. It aims to see how effective this combination is in controlling the progression of the disease.See study design

What are the potential side effects?

Possible side effects may include blood disorders like low platelet counts, issues with liver function tests, kidney problems indicated by creatinine levels, fatigue from anemia (low hemoglobin), infection risks due to neutrophil count changes, and potential heart complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer was confirmed by a lab test and I've had surgery or radiotherapy.

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My prostate cancer is worsening despite hormone therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ collected at screening, v2, v3, v5, v9 then every 4 weeks till psa progression or end of study at approximately 100 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~collected at screening, v2, v3, v5, v9 then every 4 weeks till psa progression or end of study at approximately 100 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and collected at screening, v2, v3, v5, v9 then every 4 weeks till psa progression or end of study at approximately 100 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of Participants Free of Radiographically Evident Metastases From Baseline to 18 Months After Study Drug Administration

Secondary outcome measures

Change in PSA Response Rate

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: 1. 177Lu-J591 + KetoconazoleExperimental Treatment3 Interventions

Ketoconazole 400 mg 3 times a day plus hydrocortisone 20 mg AM, 10 mg PM x 4 weeks followed by 177Lu-J591 Infusion, continue ketoconazole and hydrocortisone

Group II: 2. 111In-J591 + KetoconazolePlacebo Group3 Interventions

Ketoconazole 400 mg 3 times a day plus hydrocortisone 20 mg AM, 10 mg PM x 4 weeks followed by 111In-J591 (placebo) Infusion, continue ketoconazole and hydrocortisone

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

177Lu-J591

2009

Completed Phase 1

~40

Ketoconazole

2011

Completed Phase 3

~1420

Hydrocortisone

2005

Completed Phase 4

~1260

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor

1,054 Previous Clinical Trials

1,316,473 Total Patients Enrolled

48 Trials studying Prostate Cancer

35,584 Patients Enrolled for Prostate Cancer

United States Department of DefenseFED

861 Previous Clinical Trials

227,139 Total Patients Enrolled

38 Trials studying Prostate Cancer

9,149 Patients Enrolled for Prostate Cancer

Scott T Tagawa, M.D.Principal InvestigatorWeill Medical College of Cornell University

Media Library

177Lu-J591 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT00859781 — Phase 2

Prostate Cancer Research Study Groups: 1. 177Lu-J591 + Ketoconazole, 2. 111In-J591 + Ketoconazole

Prostate Cancer Clinical Trial 2023: 177Lu-J591 Highlights & Side Effects. Trial Name: NCT00859781 — Phase 2

177Lu-J591 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00859781 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many geographical sites are managing the trial?

"At the moment, 5 medical facilities are running this trial: Georgetown University Medical Center (Washington D.C.), Indiana University Melvin and Bren Simon Cancer Centre (Indianapolis), University of Iowa Hospitals and Clinics (Iowa City) along with another two locations."

Answered by AI

Is enrollment open for this experiment?

"The records found on clinicaltrials.gov state that this specific trial, which was first posted in June 2009 and updated lastly in March 2022 is no longer looking for participants. However, there are 1,411 other trials actively searching for patients at the moment."

Answered by AI

Have any other investigations used 177Lu-J591 as a focal point?

"177Lu-J591 was initially researched in 1995 at the NIH Clinical Center. Over 285 trials have been finalized, and currently 96 are ongoing; numerous of these studies take place Washington D.C."

Answered by AI

What therapeutic purpose does 177Lu-J591 serve?

"177Lu-J591 is usually prescribed to patients struggling with varicella-zoster virus acute retinal necrosis but has been approved for the treatment of multiple other ailments, such as neoplasms, vaginal candidiasis and iritis."

Answered by AI

How many participants are currently recruited for this experiment?

"Unfortunately, this trial is no longer accepting new candidates. Initially posted on June 1st 2009 and recently updated on March 25th 2022, the study has since closed its doors to applications. However, there are still 1315 trials recruiting patients with prostate cancer as well as 96 studies for 177Lu-J591 taking in volunteers."

Answered by AI

What potential hazards come with the utilization of 177Lu-J591?

"Because of the lack of evidence supporting efficacy, 177Lu-J591 was assigned a score of 2 on our safety scale due to its status as an experimental Phase 2 trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2009. "177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00859781.

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