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ADT + Abiraterone Acetate + Prednisone + Apalutamide for Prostate Cancer
Study Summary
This trial is for prostate cancer patients who have received radiation and hormonal therapy, whose PSA is still detectable, and have received 6-12 months of hormonal therapy. The study drugs are LHRHA, Abiraterone Acetate, Apalutamide, and Prednisone.
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 2 trial • 86 Patients • NCT03279250Trial Design
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- I have signed the consent form and agree to share my health information.My blood clotting tests are within normal limits, or I'm on specific blood thinners.I have had a radical prostatectomy.My liver is not working well (moderate to severe issues).My liver functions and blood potassium levels are within normal ranges.I had a bone scan to check for prostate cancer spread before or shortly after starting hormone therapy.My high blood pressure is under control with medication.I have a stomach or intestine condition that affects how my body absorbs food.My bilirubin levels are within normal limits.My prostate cancer is considered high risk based on its stage, Gleason score, or PSA levels.I have a history of seizures or conditions that could lead to seizures.I can follow the study's procedures for its duration.My PSA levels are detectable after treatment and I've been on hormone therapy for 6-12 months for my high-risk or N1 prostate cancer.I am 18 years old or older.I have hepatitis C or had it but my recent tests show no active virus.I don't have another cancer under treatment, visible on scans, or at high risk of returning within 5 years.I do not have any ongoing illnesses or social situations that would prevent me from following the study's requirements.My kidney function is good, with a clearance rate of at least 45 mL/min.I have tested positive for HIV or have AIDS.I am not taking abiraterone with certain other drugs that could interact badly.My recent tests show my organs are functioning well.My blood clotting time is within normal limits, or I am on specific blood thinners.I am not taking any medications listed in Section 5.4 or can stop them if required.I can take care of myself and am up and about more than half of my waking hours.I need to take more than 10 mg of prednisone daily for another health issue.I haven't needed blood transfusions or growth factors in the last 3 months.I haven't had serious heart issues or blood clots in the last 6 months.I do not have active hepatitis B but may have had it in the past.I have stopped taking any medications that can increase my risk of seizures before starting the study treatment.I have Gilbert's syndrome but my direct bilirubin levels are within the acceptable range.I can swallow pills.My kidney function is good, with a clearance rate of 45 mL/min or higher.My prostate cancer diagnosis was confirmed through a tissue examination.
- Group 1: LHRH Agonist or Antagonist
- Group 2: Prednisone+Apalutamide+Abiraterone Acetate +LHRH Agonist
- 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
Are there a considerable number of hospitals conducting this trial domestically?
"Currently, there are six sites around the world that are recruiting patients for this study. The locations include South Weymouth, Kelowna, Milford and other cities. If you want to participate in this trial, please select the location nearest you to reduce travel demands."
How many patients are being monitored in this clinical trial?
"Information available on clinicaltrials.gov suggests that this trial is currently looking for 400 participants across 6 sites. The listing was first posted on 4/20/2020, with the most recent update being on 7/14/2022."
Is there a precedent for using Apalutamide in medical research?
"Apalutamide was first trialed in 2001 at Hulston Cancer Center. There have been 752 completed studies since then, with 444 of them being active as of now. Many of these trials are based in South Weymouth, British Columbia."
Are participants still being recruited for this research project?
"This clinical trial, which was first posted on 4/20/2020 and last updated on 7/14/2022, is seeking participants."
What are the odds of experiencing adverse side effects from Apalutamide?
"Apalutamide has received a safety score of 3. This is based on the fact that it is a Phase 3 trial, meaning there are data to support both efficacy and multiple rounds of safety testing."
Why is Apalutamide being taken by most people?
"Apalutamide is most frequently used to ameliorate the symptoms of thyroiditis. However, this medication can also be effective in treating non-metastatic prostate cancer, ulcerative colitis, and malignant neoplasms."
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