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Chemotherapy + Hormone Therapy With Surgery for Prostate Cancer
Study Summary
This trial is comparing docetaxel given before surgery to surgery alone in treating patients with high-risk localized prostate cancer to see if it is more effective.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2012 Phase 3 trial • 5351 Patients • NCT00003782Trial Design
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Who is running the clinical trial?
Media Library
- I have a history of blood clots or stroke and cannot undergo major prostate surgery.I am 18 years old or older.I am able to get out of my bed or chair and move around.I currently have cancer.I have not had any cancer except for basal or squamous cell skin cancer in the last 5 years.My cancer is not small cell, neuroendocrine, or transitional cell carcinoma.I need assistance with my daily activities due to my health condition.My cancer is in an early stage and has not spread, as confirmed by scans.I am a good candidate for prostate surgery and expected to live more than 10 years.I have a history of blood clots but am considered fit for prostate surgery.I am under 18 years old.My cancer is confirmed as prostate adenocarcinoma.My prostate cancer is aggressive, with a high Gleason score or a low chance of being progression-free in 5 years.I have prostate cancer and haven't had surgery, radiation, or chemo, but may have had up to 4 months of hormone therapy.My prostate cancer's aggressiveness has been measured.I have had a condition where my lymphocytes multiply unusually.
- Group 1: Arm A: docetaxel + LHRH agonist + surgical intervention
- Group 2: Arm B: surgical intervention
- 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.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
In how many different geographical areas is this trial taking place?
"Currently, this trial is enrolling at 100 sites. The locations are based in Billings, Jackson and Robbinsdale as well as 100 other locations. If you choose to participate, it is important to select the location closest you to minimize travel demands."
Are there any current vacancies for participants in this research?
"The latest information from clinicaltrials.gov is that this study has completed recruiting patients for the trial. The trial was posted on May 8th, 2007 and last edited January 10th, 2020. Even though this specific study isn't looking for more participants, there are 1,790 other trials going on right now that are actively enrolling patients."
Are there any life-threatening dangers associated with docetaxel?
"Docetaxel is considered safe by our team at Power, who gave it a score of 3. This is due to the fact that docetaxel is currently in Phase 3 trials, meaning there is preliminary evidence of its efficacy as well as multiple rounds of data affirming its safety."
How many test subjects are involved in this experiment?
"While this study is no longer recruiting, it's worth noting that there are currently 1364 trials for patients with prostate cancer and 426 trials for docetaxel."
How effective has docetaxel been in other medical trials?
"426 clinical trials are currently being conducted for docetaxel. Of those, 163 have progressed to Phase 3 testing. 29427 locations around the world are running studies on this cancer treatment medication, with most of the research teams based out of Duarte, California."
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