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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

Must not have

Platelet count <150,000/mm3 or known primary qualitative platelet disorder

Prior radiation therapy encompassing >25% of skeleton

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

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My platelet count is below 150,000 or I have a known platelet disorder.

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I have had radiation therapy on more than a quarter of my bones.

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I do not have serious heart, lung, brain, kidney, liver, or blood diseases that could affect my participation.

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I have previously been treated with 89Strontium or 153Samarium.

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I have used ketoconazole for prostate cancer treatment for more than a month.

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I have an active cancer that is not non-melanoma skin cancer.

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I have been diagnosed with myelodysplastic syndrome.

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I have severe heart problems.

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I need assistance with my daily activities.

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I have been diagnosed with HIV.

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I am currently fighting a serious infection.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

Hydrocortisone

2005

Completed Phase 4

~1280