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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No uncontrolled ventricular arrhythmia
Continued PSA elevation after cessation of prior antiandrogen therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying how well DHA-paclitaxel works in treating patients with metastatic prostate cancer.
Who is the study for?
This trial is for adults with metastatic prostate cancer that hasn't improved with hormone therapy. They should have measurable disease, rising PSA levels despite stopping antiandrogen drugs, and a low testosterone level. No brain metastasis or recent heart attacks are allowed, and they must not have had certain treatments like taxanes or radiotherapy recently.Check my eligibility
What is being tested?
The study is testing the effectiveness of DHA-paclitaxel in patients whose prostate cancer has spread and isn't responding to hormone treatment anymore. It's a Phase II trial focusing on how well this chemotherapy drug works against advanced cancer.See study design
What are the potential side effects?
DHA-paclitaxel can cause side effects such as allergic reactions, changes in blood counts leading to increased infection risk or bleeding problems, nerve damage resulting in numbness or tingling sensations, muscle pain, nausea, vomiting, hair loss and fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart rhythm is stable and controlled.
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My PSA levels are still high after stopping hormone therapy for prostate cancer.
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I do not have spinal cord compression.
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I do not have any serious or unstable health conditions.
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I do not have cancer that has spread to my brain.
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I am fully active or can carry out light work.
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I do not have uncontrolled seizures.
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My prostate cancer was confirmed by a lab test.
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I do not have superior vena cava syndrome.
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I am 18 years old or older.
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I have not had surgery to remove my testicles and am continuing hormone therapy.
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I do not have severe numbness or pain in my hands or feet.
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My cancer has spread and is getting worse despite hormone treatment.
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I do not have a serious infection needing IV treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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Who is running the clinical trial?
TheradexLead Sponsor
33 Previous Clinical Trials
1,562 Total Patients Enrolled
Michael A. Carducci, MDStudy ChairSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
7 Previous Clinical Trials
343 Total Patients Enrolled
4 Trials studying Prostate Cancer
105 Patients Enrolled for Prostate Cancer
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Eligibility Criteria:
This trial includes the following eligibility criteria:- It's been over 2 weeks since my last major surgery and I've recovered.It's been over 28 days since I last used herbal preparations.I do not have cancer that has spread to my brain.My heart rhythm is stable and controlled.I haven't received nonhormonal treatments for my advanced cancer.My PSA levels are still high after stopping hormone therapy for prostate cancer.I do not have spinal cord compression.I do not have any serious or unstable health conditions.I have never been treated with taxanes.I am not currently on any hormonal therapy.I have no other cancers except for treated skin cancer or a cancer cured by surgery over 5 years ago.I am not taking any other cancer treatments.I am fully active or can carry out light work.I have not received samarium SM 153 or strontium chloride Sr 89 treatments.I am not currently receiving any form of radiotherapy.I have not had a heart attack in the last 3 months.I do not have uncontrolled seizures.My prostate cancer was confirmed by a lab test.I do not have superior vena cava syndrome.I am 18 years old or older.I have not had surgery to remove my testicles and am continuing hormone therapy.I do not have severe numbness or pain in my hands or feet.I am not currently on immunotherapy.My cancer has spread and is getting worse despite hormone treatment.I do not have a serious infection needing IV treatment.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- 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.
How many research centers are currently trialing this protocol?
"Arizona Oncology Associates in Tucson, the Lucille Parker Markey Cancer Center at the University of Kentucky, and Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins are only a few of 8 trial sites running this clinical experiment."
Answered by AI
Has this intervention achieved the requisite approval from the relevant governing body?
"There is limited clinical data in support of the safety of this treatment, thus it was given a score of 2. No efficacy evidence exists for this Phase 2 trial."
Answered by AI
Are participants accepted at this point in the experiment?
"Unfortunately, clinicaltrials.gov confirms that participants are not being sought for this trial at present. Initially posted on April 1st 2001 and last updated in July 2008, it appears to have concluded its recruitment phase; however there are still 1321 other trials looking for volunteers right now."
Answered by AI
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