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Darolutamide vs Enzalutamide for Prostate Cancer (ARAMON Trial)
ARAMON Trial Summary
This trial aims to find a better way to treat prostate cancer that has returned after local treatment, with fewer side effects than existing treatments.
ARAMON Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ARAMON Trial Design
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Who is running the clinical trial?
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- I have not had radiation or major surgery in the last 4 weeks.My prostate cancer diagnosis was confirmed through lab tests.I had hormone therapy for prostate cancer, but not in the last 6 months.My blood pressure is not well-controlled.I am a man aged 18 or older.I haven't used herbal products like saw palmetto in the last 4 weeks.I have been treated with specific prostate cancer drugs like enzalutamide or abiraterone.I have a stomach or intestine condition that affects how I absorb medications.My organs are functioning well enough for treatment.I had surgery or radiation for prostate cancer when it was only in the prostate.I haven't had a stroke, heart attack, severe heart chest pain, heart surgery, or severe heart failure in the last 6 months.My PSA level is above 0.2 ng/mL after surgery or radiation, or it has increased by more than 2 ng/mL from its lowest point after only radiation.I haven't taken systemic steroids in the last 3 months and don't expect to need them during the study.I am fully active or can carry out light work.I have had cancer before, but it was not serious or was a type of skin or superficial bladder cancer.I have fewer than 5 cancer spots that don't cause pain needing strong painkillers.
- Group 1: Randomized phase: Darolutamide treatment
- Group 2: Lead-in phase: Darolutamide treatment
- Group 3: Randomized phase: Enzalutamide treatment
- 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
How many people are involved in this clinical experiment?
"Affirmative. Per the information hosted on clinicaltrials.gov, this experiment is still recruiting test subjects, which were initially posted for recruitment in December 19th 2022 and most recently edited on January 20th 2023. A total of 65 participants are required from one location."
Has the Food and Drug Administration sanctioned the use of Darolutamide for Lead-in phase treatment?
"Due to the lack of efficacy data, lead-in phase darolutamide treatment was given a rating of 2 on our safety scale at Power. This is based on Phase 2 trial results that suggest some degree of safety but not yet efficacy."
Are any participants currently being accepted for this experiment?
"Affirmative, the clinical study is still open for enrollment. Initially posted on December 19th 2022 and edited as recently as January 20th 2023, this trial seeks 65 participants from a single site."
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