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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
IST 16167 Trial 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.Check my eligibility
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.See study design
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.
IST 16167 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
IST 16167 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To determine the pathologic response rate of neoadjuvant therapy with the combination of docetaxel and ketoconazole given to patients who are at a high risk of recurrence of prostate cancer.
Secondary outcome measures
To assess in preliminary fashion whether of this treatment will decrease the incidence of biochemical recurrence and provide a survival benefit as compared to patients with local treatment only or other adjuvant therapies.
IST 16167 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
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
2,163 Previous Clinical Trials
3,512,460 Total Patients Enrolled
47 Trials studying Prostate Cancer
6,421 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has not spread to distant parts of my body.My liver tests are within the allowed range for the study.I have not had surgery, radiation, or hormone therapy for my condition.I agree to use effective birth control during and for 3 months after treatment.My prostate cancer is high risk based on PSA levels, Gleason score, or biopsy results.I have never had peptic ulcer disease that needed surgery or endoscopy.My prostate cancer is confirmed by a biopsy.I am 18 years old or older.I am not taking any medications broken down by the enzyme cytochrome P450-3A4.Before taking docetaxel, my blood counts meet the required levels.I am on warfarin and can have my blood clotting time checked weekly.I have not been treated with chemotherapy for another type of cancer.I do not have severe nerve damage in my hands or feet.I am not taking corticosteroids for any other illness.I am physically active and considered fit for prostate surgery.
Research Study Groups:
This trial has the following groups:- Group 1: A
Awards:
This trial has 3 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What conditions is Ketoconazole prescribed to treat?
"Primarily used for cutaneous candidiasis, Ketoconazole can also be applied to a range of bacterial vaginosis and fungal infections such as tinea pedis caused by epidermophyton floccosumin and systemic candidiasis."
Answered by AI
Is there still capacity to enroll participants in this research project?
"According to data on clinicaltrials.gov, this medical trial is no longer looking for participants. It was initially posted on September 1st 2004 and last modified on March 25th 2009; however, there are 1650 other trials actively recruiting at the moment."
Answered by AI
How many individuals are eligible to partake in this trial?
"At the present moment, this trial is not accepting any new participants. It was initially posted in September of 2004 and its information was last revised on March 25th 2009. If you are seeking other trials to join, there are 1321 clinical studies recruiting patients with prostate cancer and 329 research projects that require volunteers for Ketoconazole treatments."
Answered by AI
Have any other experiments studied the efficacy of Ketoconazole?
"Currently, 329 Ketoconazole studies are being conducted globally. Of these ongoing experiments, 127 have entered Phase 3 trials with the majority taking place in São Paulo, RS and 22416 other sites hosting clinical investigations for this treatment."
Answered by AI
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