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Antiandrogen + Radiation +/- Docetaxel for Prostate Cancer
Study Summary
This trial is testing docetaxel in combination with antiandrogen therapy and radiation therapy versus antiandrogen therapy and radiation therapy alone in treating patients with prostate cancer that has been removed by surgery.
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.Trial Design
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Who is running the clinical trial?
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- I have a history of inflammatory bowel disease.I have been mostly active and able to carry out all my pre-disease activities up to 90 days before registration.I had surgery to remove my prostate gland.I am currently on IV antibiotics for a bacterial or fungal infection.I am not currently taking, nor planning to take, strong medication that affects liver enzymes.I had surgery to remove my prostate gland.I have undergone surgery to remove my prostate.I've had a CT or MRI scan of my abdomen/pelvis in the last 120 days without signs of metastatic lymph nodes.I've had a bone scan or similar test within the last 4 months to check for cancer spread.My cancer has spread to other parts of my body.I have been cancer-free for at least 2 years, except for non-dangerous skin cancer or very early bladder cancer.I have had treatments like cryoablation or HIFU for prostate cancer.I have a history of hepatitis B or C.My prostate cancer score is 7 or higher and my PSA level was above 0.2 ng/ml before starting hormone therapy.My testosterone level was checked after prostate surgery but before starting hormone therapy.I had surgery for prostate cancer less than a year ago.I've had treatments for an enlarged prostate or HIFU before my prostate surgery.I stopped hormone therapy for prostate cancer at least 90 days ago.I have had treatments for an enlarged prostate or specific ultrasound therapy before prostate removal.I stopped hormone therapy for prostate cancer at least 90 days ago.My lymph nodes were tested and found to be cancer-free or were not tested.I've had a bone scan or similar test within the last 4 months to check for cancer spread.I have been mostly active and able to carry out all pre-disease activities without restriction in the last 3 months.My hemoglobin level is at least 10.0 g/dl without any medical help.My lymph nodes were tested and found to be cancer-free or were not tested.I've had a CT or MRI scan of my abdomen/pelvis in the last 120 days showing no major lymph node issues.I had a major heart attack in the last 6 months.I haven't been hospitalized for lung problems in the last 15 days.I do not have any severe illnesses that my doctor thinks would make chemotherapy unsafe for me.I am HIV positive but my CD4 count is 200 or higher because I'm on HAART.My prostate cancer score is 7 or higher and my PSA level was above 0.2 ng/ml before starting hormone therapy.My testosterone level was checked after prostate surgery and before starting hormone therapy.I had surgery for prostate cancer less than a year ago, and it was confirmed to be adenocarcinoma.I've had radiation in the same area where my current cancer is.My hemoglobin level is at least 10.0 g/dl without any medical help.I have had surgery to remove my prostate.I've had chemotherapy for this cancer before, but treatments for other cancers were over two years ago.I haven't been hospitalized for heart issues like unstable angina or heart failure in the last 6 months.I had my prostate surgery more than a year ago.My bilirubin levels are normal, or I have Gilbert's syndrome.My cancer tissue sample is available for genetic testing.My cancer tissue sample is available for genetic testing.
- Group 1: Arm I (androgen deprivation therapy, EBRT)
- Group 2: Arm II (androgen deprivation therapy, EBRT, docetaxel)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What conditions has Docetaxel been shown to be effective against?
"Docetaxel is primarily used to soothe skin conditions. However, it can also be used as treatment for metastatic bladder cancer, anger management therapy, and advance directives."
How many different places is this research project being organized and executed?
"There are 103 locations for this clinical trial, with 3 sites being Aria Health-Torresdale Campus in Philadelphia, Pennsylvania, Kaiser Permanente-Oakland in Oakland, California and Mercy Hospital Saint Louis in Saint Louis, Missouri."
How many volunteers are currently enrolled in this research?
"This study is not looking for volunteers at this time. The clinical trial was first posted on January 16th, 2017 and the last update was on September 7th, 2022. However, if you are interested in other trials, there are presently 2019 clinical trials actively recruiting participants with adenocarcinoma and 569 trials for Docetaxel admitting participants."
What other treatments has Docetaxel been trialed against?
"As of now, 569 clinical trials are underway that focus on Docetaxel. Of those active studies, 197 have reached Phase 3 testing. Given the broad scope of this research, 30749 locations across the globe are running these types of trials."
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