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Androgen Receptor Inhibitor
Darolutamide vs Enzalutamide for Prostate Cancer (ARAMON Trial)
Phase 2
Recruiting
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the signing of informed consent form (icf) up to 30 days after last dose administration, up to 13 months
Awards & highlights
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.
Who is the study for?
Men over 18 with hormone-naïve prostate cancer that's come back after surgery or radiation, shown by rising PSA levels without visible spreading. They must have good organ function and no more than five non-painful metastatic lesions. No recent major surgeries or certain past treatments like ADT in the last six months are allowed.
What is being tested?
The ARAMON study is testing how Darolutamide affects testosterone levels compared to Enzalutamide in men with recurring prostate cancer not treated hormonally before. Initially, all take Darolutamide; based on results, they may later be randomly assigned to continue it or switch to Enzalutamide.
What are the potential side effects?
Possible side effects include feminizing effects such as breast growth and tenderness due to increased testosterone from Enzalutamide. Darolutamide might cause fewer CNS-related side effects because of its structure limiting brain entry.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the signing of informed consent form (icf) up to 30 days after last dose administration, up to 13 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the signing of informed consent form (icf) up to 30 days after last dose administration, up to 13 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Lead-in phase: Number of participants with Adverse Event (AE)
Randomized Phase: Number of participants with Adverse Event (AE)
Randomized Phase: Quality of life (QoL) assessments
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Randomized phase: Darolutamide treatmentExperimental Treatment1 Intervention
The conduct of the randomized phase is dependent on the results of the lead-in phase.
Group II: Lead-in phase: Darolutamide treatmentExperimental Treatment1 Intervention
Darolutamide treatment arm is single cohort in lead-in phase.
Group III: Randomized phase: Enzalutamide treatmentActive Control1 Intervention
The conduct of the randomized phase is dependent on the results of the lead-in phase.
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Who is running the clinical trial?
BayerLead Sponsor
2,260 Previous Clinical Trials
25,309,380 Total Patients Enrolled
42 Trials studying Prostate Cancer
26,048 Patients Enrolled for Prostate Cancer
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Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Randomized phase: Darolutamide treatment
- Group 2: Lead-in phase: Darolutamide treatment
- Group 3: Randomized phase: Enzalutamide treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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