A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies (ARASTEP)
Darolutamide in Phase 3 clinical Trial: For Patients with High-Risk Biochemical Recurrence (BCR) of Prostate Cancer After Surgery or Radiation
Background Information
- High-Risk Biochemical Recurrence (BCR) means your prostate-specific antigen (PSA) levels have gone up after you finished local treatments (such as surgery or radiation).
- Even though your scans might not show any cancer, a fast-rising PSA (short “PSA doubling time”) can mean your prostate cancer is more likely to return or spread.
- Standard care often involves hormone therapy (androgen deprivation therapy, or ADT) to lower male hormones (testosterone) that help the growth of cancer cells.
- This study will see if adding the investigational drug, darolutamide to ADT can slow or stop cancer in people with high-risk BCR.
Why Look at PSMA PET/CT?
- PSMA PET/CT is a newer and more sensitive imaging method than traditional scans.
- It can detect small areas of cancer earlier, which can help doctors choose the right treatments sooner.
- If you have high-risk BCR, any cancer spots found on a PSMA PET/CT may need effective treatment to delay growth and spread.
About the investigative drug, Darolutamide
The current trial, called ARASTEP (NCT05794906), will test whether darolutamide + ADT works better than placebo + ADT at preventing cancer from getting worse on PSMA PET/CT scans.
Purpose of the Study
To learn if the combination of the investigational drug darolutamide and ADT prolongs the time that the participants live without their cancer getting worse, or to death due to any cause, compared to placebo (which is the treatment that looks like a medicine but does not have any medicine in it) and ADT given for a pre-specified duration of 24 months.
How the Study Works
Study participants will be randomly (by chance) allocated to one of two treatment groups. Based on the allocated treatment group, the participants will either take:
1. The investigational drug darolutamide plus ADT twice daily as tablets by mouth
OR
2. Placebo plus ADT twice daily as tablets by mouth
The study will consist of a test (screening) phase, a treatment phase and a follow-up phase. The treatment duration is pre-specified to be 24 months unless the cancer gets worse, the participants have medical problems, or they leave the study for any reason. In addition, image guided radiotherapy (IGRT) or surgery is allowed and your doctor will explain the benefits and risks of this type of therapy.
Study Details
This Phase 3 trial (sponsored by Bayer, study number NCT05794906) will evaluate the safety and effectiveness of darolutamide combined with ADT.
About 970 participants worldwide will join.
- Investigational Drug
- Darolutamide: 600 mg (2 tablets of 300 mg) twice daily (BID) or
- Placebo: tablets matched to darolutamide tablets in appearance twice daily (BID)
- Background therapy: ADT (Androgen Deprivation Therapy) You will take pills twice a day for 24 months, or until the cancer grows or side effects become too severe according to your treating physician.
Who Can Join?
Key Eligibility
- Men age 18 or older who had local treatment (surgery or radiation) for prostate cancer in the past.
- Rising PSA levels that meet “high-risk” standards, such as a quick doubling time.
- At least one visible lesion on a PSMA PET/CT scan.
- Normal or near-normal heart, liver, and kidney function.
- Testosterone ≥150 ng/dL.
Exclusions
- Prostate cancer with other aggressive features (e.g., strong neuroendocrine or small-cell traits).
- Previous therapies with darolutamide or similar medicines (e.g., enzalutamide, apalutamide) in the last 18 months.
- Cancer that has spread to areas like the brain.
- Another active or recent cancer (except some early-stage or skin cancers) within the last 5 years.
(This is not a full list. Please talk with the study team or check ClinicalTrials.gov for full details.)
What’s Involved?
Monitoring
- Doctors will watch your PSA levels, do PSMA PET/CT scans, and check your health.
- You will stay on study treatment as long as there is no progression and after progression you will stay in the study for further follow-up even if a new anti-cancer therapy is needed.
What to Expect
You may not receive any benefits from participating in this study. However, you will get regular medical checkups and close monitoring. You will also have PSMA PET/CT scans, which can find cancer earlier than standard imaging. You may experience side effects.
Safety Follow-up
Assessing the number of participants with side effects categorized by severity. Assessment will be done after the first treatment until 30 days (+7 days) after the last treatment, up to 25 months.
Assessing the number of participants who discontinue study treatment due to side effects.
Organization & Contact
Sponsor: Bayer
ClinicalTrials.gov ID: NCT05794906
To learn more, visit ClinicalTrials.gov or talk with your doctor to see if this trial is right for you.
Note: This information is informative. Discuss any trial participation with your doctor to decide what is best for you.
