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Enzalutamide +/- Radium Ra 223 for Prostate Cancer
Study Summary
This trial studies how well enzalutamide with or without radium Ra 223 dichloride works in treating patients with castration-resistant prostate cancer.
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 am not taking oral steroids or immunosuppressants, except for adrenal replacement.I do not have untreated brain metastases or leptomeningeal disease.I have hepatitis B, C, or cirrhosis.I do not have any severe illnesses that would stop me from following the study's requirements.I have not taken ARN-509 or enzalutamide for more than 15 days.I am not currently using specific hormone therapies for cancer, or I can stop them for 2 weeks before starting the study drug.I have been treated with specific radioactive drugs for bone cancer spread.I have prostate cancer that has spread to my bones, with or without symptoms.My prostate cancer has worsened despite low testosterone levels.I haven't had docetaxel or cabazitaxel for my advanced prostate cancer, but I may have had abiraterone.I am fully active or can carry out light work.I am a man with bone metastases, but may also have cancer spread to organs.I have had treatment for spinal cord compression.I haven't had seizures, TIAs, or strokes in the last 6 months.My cancer has spread to a new area.I had radiation therapy over 4 weeks ago for bone metastasis but have at least one bone metastasis that wasn't treated.I have been treated with docetaxel or cabazitaxel for prostate cancer.My cancer symptoms are worsening despite hormone therapy or my testosterone is low.I have chronic diarrhea or have been diagnosed with Crohn's or ulcerative colitis.
- Group 1: Arm I (enzalutamide, radium 223)
- Group 2: Arm II (enzalutamide)
- 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.
- 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
Has Enzalutamide received the requisite FDA clearance?
"Enzalutamide's safety has been established to a degree, thus it earns a rating of 2. This is because the clinical trial status for this drug is Phase 2 and there are no results indicating its efficacy yet."
What is the total number of individuals being recruited for this investigation?
"Unfortunately, this clinical trial has already filled its quota of participants and is no longer accepting new ones. The study was posted on November 21st 2018 and the last update occurred August 6th 2022. If you are curious about other trials, there are presently 3654 studies actively recruiting patients with prostate cancer as well as 98 Enzalutamide-related investigations currently enrolling individuals."
Is this medical study currently recruiting participants?
"Currently, there is no recruitment for this specific medical trial. First posted on November 21st 2018 and last updated August 6th 2022; if you are seeking other trials, 3654 studies regarding prostate cancer are actively recruiting patients and 98 involving Enzalutamide require volunteers."
Are there any precedents of employing Enzalutamide in clinical research?
"Currently, 98 Enzalutamide studies are live and 30 of them are in Phase 3. Germantown, Tennessee is one hub for these trials but a total of 5740 locations across the world offer clinical trial opportunities with this drug."
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