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Combination Therapy for Prostate Cancer
Study Summary
This trial is testing abiraterone acetate, prednisone, and apalutamide with or without ipilimumab or cabazitaxel and carboplatin to treat 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 have active or symptomatic viral hepatitis or chronic liver disease.I haven't taken specific prostate cancer drugs or chemotherapy in the last year.I do not have an active infection or a condition that prevents steroid use, and I do not have HIV/AIDS.My cancer outside of bones is growing or new.I am undergoing treatment to lower my testosterone levels below 50 ng/dL.I haven't had any prostate cancer treatment in the last 28 days, except for hormone therapy or bone metastases treatment.My cancer did not respond to more than 2 chemotherapy treatments.I haven't taken Flutamide, Bicalutamide, or Nilutamide recently, or I meet the exception criteria.I had radiation for my main cancer site within 6 weeks or had palliative radiation and am recovered.I take more than 10mg of prednisone daily for a chronic condition, but short-term or topical steroids are okay.I have untreated spinal cord compression that causes symptoms.I have had serious heart issues or a heart attack in the last 6 months.I stopped taking any medication that could increase my risk of seizures 4 weeks ago.My kidneys are functioning well enough (creatinine clearance >= 40 mL/min).I agree to use two forms of birth control and not donate sperm until 3 months after my last treatment dose.I do not have autoimmune diseases like Crohn's, lupus, or rheumatoid arthritis.I have a history of seizures or conditions that could lead to seizures.I can take care of myself but might not be able to do heavy physical work.My hemoglobin level is at least 7.5 g/dL without transfusions or growth factors in the last 3 months.My platelet count is at least 100,000 without transfusions in the last 3 months.My blood pressure is controlled with medication.I have a history of conditions that could cause my bowel to tear.My liver enzymes are within the required range for my condition.I have previously been treated with ipilimumab.I haven't had cancer treatments in the past 5 years, except for non-serious skin or bladder cancer.My cancer progressed despite recent specific treatments or it's been over a year since those treatments without progression.My prostate cancer was confirmed by a lab test.I have a digestive condition that affects how my body absorbs food.My bone scan shows 2 or more new lesions due to prostate cancer.I can swallow pills without any difficulty.
- Group 1: Arm 3(abiraterone, prednisone, ARN509,cabazitaxel,carboplatin)
- Group 2: Arm 2A (abiraterone acetate, prednisone, apalutamide)
- Group 3: Arm 2B (abiraterone acetate, prednisone, ARN-509, ipilimumab)
- 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
For which illnesses is Abiraterone Acetate typically prescribed?
"Abiraterone acetate is frequently used as a first-line therapy, and has also been demonstrated to be therapeutic for ophthalmia, sympathetic neuralgia, scalp structure irregularities, and advanced testicular cancer."
What hazards are associated with Abiraterone Acetate consumption?
"An overall assessment of abiraterone acetate's safety yielded a rating of 2. This is due to the fact that, since it has only reached Phase 2 clinical trials, there are no studies as yet providing evidence for its efficacy; however, some data does exist suggesting its safety."
How many individuals are partaking in this experiment?
"Unfortunately, this medical trial is not presently recruiting. First posted on May 18th 2016 and last updated on February 11th 2022, the study has since concluded its recruitment process. However, there are 3,650 studies searching for participants with carcinoma and 1,455 trials actively administering Abiraterone acetate to patients."
Is there still an opportunity to become involved with this research endeavor?
"As seen on clinicaltrials.gov the recruitment process for this medical trial has officially ended, with its initial post date being May 18th 2016 and its last update occurring February 11th 2022. Nevertheless, there are a multitude of other studies that require participants at present - 5105 to be exact."
What prior research has been conducted regarding the application of Abiraterone Acetate?
"Currently, there are 1455 active research studies into Abiraterone acetate, with 383 of them in Phase 3. Majority of these clinical investigations take place in Shanghai; however, this compound is getting tested on 83312 different sites worldwide."
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