Your session is about to expire
← Back to Search
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 after randomization to after last treatment, approximately 24 months
Awards & highlights
Pivotal Trial
Summary
This trial is researching if a combination of ADT and darolutamide can help men with prostate cancer at high risk of biochemical recurrence (BCR) live longer without their cancer getting worse.
Who is the study for?
This trial is for men over 18 with hormone-sensitive prostate cancer who've had a rise in PSA levels after local treatments like surgery or radiation. They must be generally healthy, able to consent, and willing to use contraception. Men with certain types of aggressive prostate cancer, previous extensive treatments, or recent other cancers are excluded.
What is being tested?
The study compares the effectiveness of darolutamide combined with ADT versus placebo plus ADT in preventing cancer progression. Participants will take these treatments orally for 24 months and undergo regular health checks including blood tests and advanced imaging scans to monitor their condition.
What are the potential side effects?
Potential side effects were not explicitly listed but may include those commonly associated with ADT such as fatigue, hot flashes, reduced sexual desire, and bone thinning. Darolutamide could also cause similar side effects due to its action on hormone receptors.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after randomization to after last treatment, approximately 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after randomization to after last treatment, approximately 24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Time to deterioration in the Functional Assessment of Cancer Therapy-Prostate (FACT-P) total score
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Darolutamide+ADTExperimental Treatment2 Interventions
Participants will receive darolutamide plus ADT twice daily with food for a pre-specified duration of 24 months.
Group II: Placebo+ADTPlacebo Group2 Interventions
Participants will receive Placebo plus ADT twice daily with food for a pre-specified duration of 24 months.
Find a Location
Who is running the clinical trial?
BayerLead Sponsor
2,274 Previous Clinical Trials
25,531,901 Total Patients Enrolled
45 Trials studying Prostate Cancer
26,975 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My prostate cancer was first treated with surgery, possibly followed by radiation, or just radiation.I haven't had PSMA-radiotherapy in the last 12 months.My prostate cancer is returning quickly, with PSA levels rising fast.I haven't had any cancer except for certain skin cancers or superficial bladder cancer in the last 5 years.I am a man aged 18 or older.I completed radiotherapy less than 8 weeks ago.I have prostate cancer that came back after radiotherapy and am eligible for surgery.I am fully active or restricted in physically strenuous activity but can do light work.I have had a PSMA PET/CT scan for prostate cancer within the last 42 days.My cancer has spread to the prostate area or nearby lymph nodes.My scans show cancer has spread to my brain.My prostate cancer is of a specific type (small cell, ductal, or mainly neuroendocrine).I have taken specific prostate cancer medications in the last 18 months.I have had surgery to remove both testicles.I have had radiation treatment in the pelvic area for another cancer.I agree to use contraception and not donate sperm as per the study's requirements.My prostate cancer was confirmed by a lab test.
Research Study Groups:
This trial has the following groups:- Group 1: Darolutamide+ADT
- Group 2: Placebo+ADT
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger