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Darolutamide + ADT for Metastatic Hormone-Sensitive Prostate Cancer (ARASEC Trial)

Phase 2
Waitlist Available
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 4 weeks since prior major surgery and recovered from all toxicity from such surgery prior to enrollment
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1 or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6 months after first administration
Awards & highlights

ARASEC Trial Summary

This trial will test if adding darolutamide to ADT will be more effective than ADT alone in men with hormone-sensitive prostate cancer that has spread to other parts of the body.

Who is the study for?
Men with metastatic hormone-sensitive prostate cancer who have started ADT up to 120 days before joining. They must have good organ function, no severe recent surgeries, and an ECOG Performance Status of 0-2. Excluded are those with certain other cancers in the last 5 years, brain metastases, uncontrolled hypertension, or previous treatments that could interfere.Check my eligibility
What is being tested?
The trial is testing if adding darolutamide to standard ADT improves progression-free survival compared to ADT alone in men with mHSPC. Progression-free survival means how long patients live without their cancer getting worse.See study design
What are the potential side effects?
Possible side effects include issues related to liver and kidney functions, blood pressure changes, gastrointestinal disturbances which might affect drug absorption, allergic reactions to study drugs or their components.

ARASEC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
It's been over 4 weeks since my last major surgery and I've recovered from it.
Select...
I am able to care for myself and perform daily activities.

ARASEC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 months after first administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 months after first administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free survival (PFS)
Secondary outcome measures
Complete PSA response rate
Number of participants with adverse events
Overall survival (OS)
+2 more

Side effects data

From 2014 Phase 3 trial • 61 Patients • NCT02012218
16%
Akathisia
16%
Diarrhoea
16%
Fatigue
11%
Increased appetite
11%
Somnolence
11%
Tension headache
11%
Restlessness
11%
Dry mouth
5%
Agitation
5%
Disinhibition
5%
Increased upper airway secretion
5%
Yawning
5%
Muscle rigidity
5%
Urinary retention
5%
Insomnia
5%
Headache
5%
Poor quality sleep
5%
Aphasia
5%
Cognitive disorder
5%
Dizziness
5%
Lethargy
5%
Distractibility
5%
Middle insomnia
5%
Constipation
5%
Oesophagitis
5%
Dyslipidaemia
5%
Upper respiratory tract infection
5%
Epistaxis
5%
Weight increased
5%
Acne
5%
Menstrual disorder
5%
Paraesthesia
5%
Vision blurred
5%
Ligament sprain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 3
Group 2
Group 1B
Group 1A
Group 4

ARASEC Trial Design

1Treatment groups
Experimental Treatment
Group I: Darolutamide+ADTExperimental Treatment2 Interventions
Participants will receive darolutamide plus ADT in the ARASEC treatment arm. The control arm for the study will be derived from the participants treated with ADT alone in the CHAARTED trial using a matching approach

Find a Location

Who is running the clinical trial?

BayerLead Sponsor
2,229 Previous Clinical Trials
25,325,214 Total Patients Enrolled
39 Trials studying Prostate Cancer
25,919 Patients Enrolled for Prostate Cancer

Media Library

ADT Clinical Trial Eligibility Overview. Trial Name: NCT05059236 — Phase 2
Prostate Cancer Research Study Groups: Darolutamide+ADT
Prostate Cancer Clinical Trial 2023: ADT Highlights & Side Effects. Trial Name: NCT05059236 — Phase 2
ADT 2023 Treatment Timeline for Medical Study. Trial Name: NCT05059236 — Phase 2

Frequently Asked Questions

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

Have there been any other research endeavors exploring the potential implications of ADT?

"Research into ADT began in 2016 when the trial NCT02799602 was initiated. 22 studies have since been concluded, with an additional 24 undergoing enrollment at present time--many of these located around Bala-Cynwyd, Pennsylvania."

Answered by AI

What is the upper limit of participants involved in this experiment?

"Affirmative. The clinicaltrial.gov website contains information showing that this trial is currently open to the public, and was first published on November 29th 2021. An update was made on November 14th 2022 with a goal of recruiting 200 patients from 10 centers."

Answered by AI

Is the intake period for this clinical trial still ongoing?

"According to the data hosted on clinicaltrials.gov, this is an ongoing medical trial that was first introduced 29th November 2021 and recently updated 14th November 2022."

Answered by AI

How many healthcare centers are currently administering this experiment?

"At present, 10 medical centres are enrolling patients in this study. These sites stretch from Bala-Cynwyd to New york City and Los Angeles amongst other metropolitan areas. Therefore it is advisable for participants to select the closest facility that can accommodate them to limit travel demands if they decide to join the trial."

Answered by AI

What potential risks are associated with androgen deprivation therapy?

"As a Phase 2 trial, ADT's safety has been partially tested and was appraised with a score of 2 on the scale. No data exists to support it effectiveness at this time."

Answered by AI

Is this investigation unprecedented in its scope?

"At the present moment, 24 separate clinical trials for ADT are taking place in 557 cities and 44 nations. The groundwork of this research was laid by Orion Corporation's Phase 3 study which commenced in 2016 with 1303 patients; since then, 22 further investigations have been conducted."

Answered by AI
~48 spots leftby Dec 2024