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abiraterone acetate for Prostate Cancer
Study Summary
This trial is studying abiraterone acetate to see if it can help treat patients with prostate cancer who have undergone initial hormone therapy.
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 2021 Phase 4 trial • 255 Patients • NCT02485691Trial Design
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Who is running the clinical trial?
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- I have had cancer before, but it meets the trial's specific criteria.I don't have active hepatitis, severe liver issues, or serious heart failure.I am not taking any medications that could affect the study drugs.I am not taking any heart rhythm altering medications.My prostate cancer diagnosis was confirmed through a tissue test.I am taking or can take Degarelix for hormone therapy.My overall health, blood, kidney, liver, and hormone levels meet the trial's requirements.My blood pressure is under control.I do not have stomach or bowel problems that affect how I absorb medicine.I have not had chemotherapy or radiopharmaceuticals for prostate cancer.I have not used ketoconazole for prostate cancer.I take 10 mg or less of prednisone daily for another health issue.I am not taking any hormone-related medications.I have never received Provenge treatment.My cancer has spread to other parts of my body and I am starting hormone therapy.I am currently on hormone therapy for my cancer.I have had both testicles surgically removed.My PSA levels did not drop enough with hormone therapy.I have never had brain cancer spread.I can swallow pills without needing to break them down.I am not planning to undergo chemotherapy, immunotherapy, surgery, or radiotherapy while on the trial treatment.My cancer has spread to either my organs, bones, or distant lymph nodes.I am not taking any antifungal medications.
- Group 1: Abiraterone acetate + prednisone
- 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
Is there availability to partake in this medical research?
"Unfortunately, this medical trial is no longer recruiting new candidates. It was initially posted on August 9th 2011 and the last update was on November 30th 2022. For individuals looking for other trials related to prostate cancer, 1321 studies are currently enrolling while 366 clinical trials are actively searching for patients who would respond well to abiraterone acetate treatment."
How many participants have enrolled in this research project?
"This trial is not currently accepting new candidates. It was initially posted on August 9, 2011 and most recently amended on November 30th 2022. If you are interested in alternative studies, there are presently 1321 clinical trials actively enrolling individuals with prostate cancer and 366 studies for abiraterone acetate seeking participants."
How many research sites are facilitating this investigation?
"Currently, this clinical trial is welcoming enrollees from 100 sites including Maywood, Overland Park and Montrose. To minimize travel burdens for participants it may be beneficial to select a site location as close by as possible."
Has abiraterone acetate been granted regulatory clearance by the FDA?
"Our team has assessed the safety of abiraterone acetate to be a 2, as this is still in Phase 2. This means there are some findings that support its security but no data verifying effectiveness yet."
Have there been any prior experiments involving abiraterone acetate?
"Presently, 366 clinical trials associated with abiraterone acetate are in progress. Of those active studies, 100 have progressed to the third stage of development. While a majority of these investigations are based out of Duarte, California, 17 421 sites across the globe are conducting research on this treatment modality."
Does this research trial have an age restriction?
"The age range for participation in this trial has been set between 18 and 120, according to the inclusion criteria."
What health conditions is abiraterone acetate commonly utilized to combat?
"Abiraterone acetate is typically used to treat thyroiditis but can be employed for other illnesses, such as varicella-zoster virus acute retinal necrosis, malignant neoplasms, and ulcerative colitis."
What criteria must a participant fulfill for eligibility in this experiment?
"Currently, a total of 41 patients suffering from prostate cancer aged between 18 and 120 are in search of enrolment for this trial. To be eligible to participate, they must meet the following qualifications: confirmation that their tumours have spread to either their axial or appendicular skeleton; evidence-based diagnosis of adenocarcinoma of the prostate; presence of metastases in other visceral organs such as the liver or lungs; having undergone bilateral surgical orchiectomy if applicable; plus distant lymph node disease above the aortic bifurcation (or similar)."
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