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Docetaxel + Ketoconazole for Prostate Cancer (IST 16167 Trial)

N/A

Waitlist Available

Research Sponsored by Kansas City Veteran Affairs Medical Center

Eligibility Criteria Checklist

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

Must have

Patients must not have received prior treatment with surgery, radiation, or hormone deprivation.

Patients must meet at least one of the following high risk criteria: PSA > 20, Gleason score 8 or greater, Presence of pathological Gleason grade 4 or higher as the majority sum on biopsy core, Greater than 50% of cores at time of biopsy positive for cancer, Clinical Stage T3 Disease.

Must not have

Patients with clinical stage T4 disease are not eligible.

Patients with a history of peptic ulcer disease requiring treatment with surgery or endoscopy are not eligible.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial will give high-risk prostate cancer patients four rounds of a combination of ketoconazole and docetaxel before they have surgery to remove the prostate.

Who is the study for?

Men over 18 with high-risk prostate cancer who haven't had surgery, radiation, or hormone therapy can join this trial. They must have a specific type of tumor (adenocarcinoma), meet certain risk criteria like a PSA >20 or Gleason score ≥8, and be fit for surgery. Those on certain drugs, with liver issues, severe allergies to docetaxel/polysorbate 80, or other cancers treated with chemo are excluded.

What is being tested?

The trial tests the combination of two drugs—Docetaxel and Ketoconazole—given before surgical removal of the prostate in men with high-risk cancer. Over four cycles (each lasting three weeks), effects on tumor response and potential recurrence will be studied along with drug levels in the body.

What are the potential side effects?

Possible side effects include allergic reactions to medication components, nerve damage (neuropathy), blood count changes leading to increased infection risk or bleeding problems, liver function alterations that could affect drug processing and increase toxicity.

Eligibility Criteria

Inclusion Criteria

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

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I have not had surgery, radiation, or hormone therapy for my condition.

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My prostate cancer is high risk based on PSA levels, Gleason score, or biopsy results.

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My prostate cancer is confirmed by a biopsy.

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I am 18 years old or older.

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I am not taking any medications broken down by the enzyme cytochrome P450-3A4.

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Before taking docetaxel, my blood counts meet the required levels.

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I am physically active and considered fit for prostate surgery.

Exclusion Criteria

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

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My cancer has not spread to distant parts of my body.

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I have never had peptic ulcer disease that needed surgery or endoscopy.

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I have not been treated with chemotherapy for another type of cancer.

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I do not have severe nerve damage in my hands or feet.

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I am not taking corticosteroids for any other illness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

1Treatment groups

Experimental Treatment

Group I: AExperimental Treatment2 Interventions

Eligible patients with high-risk prostate cancer who are scheduled to undergo radical prostatectomy will receive four cycles of therapy with ketoconazole and docetaxel prior to surgery resection

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ketoconazole

FDA approved

Docetaxel

FDA approved

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kansas City Veteran Affairs Medical CenterLead Sponsor

23 Previous Clinical Trials

8,548 Total Patients Enrolled

1 Trials studying Prostate Cancer

52 Patients Enrolled for Prostate Cancer

SanofiIndustry Sponsor

2,187 Previous Clinical Trials

3,979,758 Total Patients Enrolled

47 Trials studying Prostate Cancer

6,421 Patients Enrolled for Prostate Cancer

Media Library

Ketoconazole Clinical Trial Eligibility Overview. Trial Name: NCT00870714 — N/A

Prostate Cancer Research Study Groups: A

Prostate Cancer Clinical Trial 2023: Ketoconazole Highlights & Side Effects. Trial Name: NCT00870714 — N/A

Ketoconazole 2023 Treatment Timeline for Medical Study. Trial Name: NCT00870714 — N/A

~1 spots leftby Sep 2025

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