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Darolutamide + ADT for Prostate Cancer (ARASTEP Trial)

Phase 3
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 after randomization to after last treatment, approximately 46 months
Awards & highlights

ARASTEP 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.Check my eligibility
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.See study design
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.

ARASTEP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after randomization to after last treatment, approximately 46 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and after randomization to after last treatment, approximately 46 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Radiological progression-free survival (rPFS) by Prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) assessed by Blinded independent central review (BICR)
Secondary outcome measures
Metastasis-free survival (MFS) by Conventional imaging (CI) assessed by BICR
Number of participants who discontinue study treatment due to a TEAE
Number of participants with Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) categorized by severity
+8 more

ARASTEP 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
2,239 Previous Clinical Trials
25,331,978 Total Patients Enrolled
39 Trials studying Prostate Cancer
25,919 Patients Enrolled for Prostate Cancer

Media Library

ADT Clinical Trial Eligibility Overview. Trial Name: NCT05794906 — Phase 3
Prostate Cancer Research Study Groups: Darolutamide+ADT, Placebo+ADT
Prostate Cancer Clinical Trial 2023: ADT Highlights & Side Effects. Trial Name: NCT05794906 — Phase 3
ADT 2023 Treatment Timeline for Medical Study. Trial Name: NCT05794906 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there opportunities to participate in this medical experiment?

"It appears that this clinical trial has already filled its quota of patients, as the listing was last updated on March 21st 2023. Nonetheless, there are 1239 other trials currently recruiting participants at this time."

Answered by AI

Has the Darolutamide+ADT drug combination been given clearance by the FDA?

"The safety of Darolutamide+ADT was rated a 3 due to the existence of evidence-backed efficacy and multiple rounds of research proving its safety."

Answered by AI

In what areas of the country is this clinical trial accessible?

"This trial is currently being administered at 184 different medical facilities. These include Tucson, Duarte and Los Angeles, among other urban centres. Potential participants should consider choosing the clinic that's closest to them in order to limit their time spent commuting."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
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
2023. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05794906.
All > Prostate Cancer Boston
~500 spots leftby Jan 2027
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