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Antiandrogen

Standard ADT (androgen deprivation therapy) for Prostate Cancer (ARASENS Trial)

Phase 3

Waitlist Available

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 first dose of darolutamide or placebo until cut-off date for the final analysis planned as 30 jun 2023 (approximately 79 months)

Awards & highlights

ARASENS Trial Summary

This trial is testing a new drug for prostate cancer that has spread and is no longer responding to hormone therapy. The new drug is called darolutamide, and it is being tested in combination with standard androgen deprivation therapy (ADT) and docetaxel.

Eligible Conditions

Metastatic Hormone Sensitive Prostate Cancer

ARASENS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the first dose of darolutamide or placebo until cut-off date for the final analysis planned as 30 jun 2023 (approximately 79 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the first dose of darolutamide or placebo until cut-off date for the final analysis planned as 30 jun 2023 (approximately 79 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the first dose of darolutamide or placebo until cut-off date for the final analysis planned as 30 jun 2023 (approximately 79 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

OS From Date of Randomization Until Death From Any Cause - Months

OS From Date of Randomization Until Death From Any Cause - Number of Events

Secondary outcome measures

Number of Participants With TEAEs

Symptomatic Skeletal Event Free Survival (SSE-FS) - Month

Symptomatic Skeletal Event Free Survival (SSE-FS) - Number of Events

+12 more

ARASENS Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: BAY1841788 /darolutamide (ODM-201)+standard ADT+DocetaxelExperimental Treatment3 Interventions

Co-administration of BAY 1841788 / darolutamide (ODM-201), standard ADT and docetaxel

Group II: Placebo + standard ADT + DocetaxelPlacebo Group3 Interventions

Co-administration of Placebo matching BAY 1841788 / darolutamide (ODM-201) tablets, standard ADT and docetaxel

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BAY1841788 / darolutamide (ODM-201)

2016

Completed Phase 3

~1310

Standard ADT (androgen deprivation therapy)

2016

Completed Phase 3

~1310

Docetaxel

1995

Completed Phase 4

~5620

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

BayerLead Sponsor

2,235 Previous Clinical Trials

25,324,257 Total Patients Enrolled

39 Trials studying Prostate Cancer

25,919 Patients Enrolled for Prostate Cancer

Orion Corporation, Orion PharmaIndustry Sponsor

137 Previous Clinical Trials

43,618 Total Patients Enrolled

5 Trials studying Prostate Cancer

407 Patients Enrolled for Prostate Cancer

Bayer Study DirectorStudy DirectorBayer

1,180 Previous Clinical Trials

4,260,633 Total Patients Enrolled

6 Trials studying Prostate Cancer

1,927 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

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

Is this experiment being conducted in a great number of hospitals across the US?

"To make participation more convenient for patients, this trial is enrolling at 56 sites. These locations include Washington, Boca Raton, and Gainesville. You can find a full list of sites on the study's website."

Answered by AI

How many individuals are being administered this medication as part of the research project?

"Unfortunately, this particular clinical trial is no longer actively seeking patients. The trial was last updated on September 28th, 2022 and was originally posted on November 30th, 2016. If you are interested in participating in other trials, there are 1507 active studies for patients with prostate cancer and 359 for Standard ADT."

Answered by AI

Are there precedents for this Standard ADT (androgen deprivation therapy)?

"There are presently 359 ongoing studies investigating Standard ADT (androgen deprivation therapy), with 140 of those in Phase 3. Of the 24097 locations running trials for this treatment, many trials for Standard ADT (androgen deprivation therapy) are based in Fuzhou, Fujian."

Answered by AI

What does the FDA have to say about Standard ADT?

"Standard ADT (androgen deprivation therapy) has received a score of 3 from our Power team. This is because it is a phase 3 trial, meaning that there is some data to support efficacy as well as multiple rounds of data to support safety."

Answered by AI