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Hormone Therapy

ADT + Apalutamide for Prostate Cancer (LIBERTAS Trial)

Phase 3
Recruiting
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Metastatic prostate cancer disease documented by conventional imaging (example, computed tomography [CT], magnetic resonance imaging [MRI], or bone scan) and/or next-generation imaging [NGI] demonstrating greater than equal (>=) 2 distinct extraprostatic sites of metastasis
Participants who have undergone a bilateral orchidectomy and/or who are actively taking gender-affirming hormone therapy as part of their gender affirming care
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years 9 months
Awards & highlights

LIBERTAS Trial Summary

This trial aims to see if using ADT intermittently can improve survival rate & reduce hot flashes in men with mCSPC, with PSA levels <0.2 ng/mL after 6 months of treatment.

Who is the study for?
This trial is for individuals assigned male at birth with advanced prostate cancer that has spread, who can perform daily activities (with or without stable physical limitations), and have not planned to conceive. They must be able to swallow medication and should not have gastrointestinal issues affecting drug absorption, a history of seizures, recent severe heart conditions, or specific allergies.Check my eligibility
What is being tested?
The study tests if taking breaks from hormone therapy after initial treatment with apalutamide reduces the growth of prostate cancer without worsening symptoms like hot flashes compared to continuous treatment. Participants' PSA levels are monitored for changes.See study design
What are the potential side effects?
Apalutamide may cause side effects such as fatigue, high blood pressure, skin rash, falls, fractures, digestive issues and can potentially increase seizure risk in predisposed individuals.

LIBERTAS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My prostate cancer has spread to 2 or more areas outside the prostate, confirmed by scans.
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I have had surgery to remove both testicles or am on hormone therapy for gender transition.
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I have been diagnosed with prostate cancer.
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I can swallow pills, with or without something like applesauce.

LIBERTAS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years 9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years 9 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
Percent Change From Randomization in Severity of Adjusted Hot Flash Score at 18 Months
Percentage of Participants With 18-Months Radiographic Progression-free Survival (rPFS)
Secondary outcome measures
Change From Baseline in European Organization for the Research and Treatment of Cancer (EORTC) Customized Study Form
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire -Prostate Cancer Module (EORTC-PR25) Questionnaire
+38 more

LIBERTAS Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B (Continuous ADT Group)Experimental Treatment2 Interventions
Participants with PSA level <0.2 ng/mL after 6 months of treatment with Apalutamide and ADT during initial treatment phase, will enter main treatment phase and continue to receive apalutamide plus ADT or followed up for at least 18 months from Day 1 of Cycle 7 (each cycle 28 days) or have discontinued the study, whichever occurs first.
Group II: Arm A (Intermittent ADT Group)Experimental Treatment2 Interventions
Participants with PSA level <0.2 ng/mL after 6 months of treatment with Apalutamide and ADT during initial treatment phase, will enter main treatment phase and treated with apalutamide with intermittent ADT per protocol or followed up for at least 18 months from Day 1 of Cycle 7 (each cycle 28 days) or have discontinued the study, whichever occurs first.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apalutamide
2015
Completed Phase 2
~3310

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
976 Previous Clinical Trials
6,384,359 Total Patients Enrolled
8 Trials studying Prostate Cancer
2,178 Patients Enrolled for Prostate Cancer
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
746 Previous Clinical Trials
3,959,945 Total Patients Enrolled
7 Trials studying Prostate Cancer
2,688 Patients Enrolled for Prostate Cancer

Media Library

Androgen-deprivation Therapy (ADT) (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05884398 — Phase 3
Prostate Cancer Research Study Groups: Arm B (Continuous ADT Group), Arm A (Intermittent ADT Group)
Prostate Cancer Clinical Trial 2023: Androgen-deprivation Therapy (ADT) Highlights & Side Effects. Trial Name: NCT05884398 — Phase 3
Androgen-deprivation Therapy (ADT) (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05884398 — 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 a plethora of medical facilities conducting this research within the state?

"This trial is taking place at Memorial Sloan Kettering in New york City, Clinical Research Solutions of Middleburg Heights Ohio and the University of Utah Huntsman Cancer Institute in Salt Lake City as well as 6 other facilities."

Answered by AI

Is there any potential for harm with the Arm A (Intermittent ADT Group) protocol?

"The safety of Arm A (Intermittent ADT Group) is appraised at 3 on a 1 to 3 scale, denoting that there are multiple rounds of data in support of its efficacy and security."

Answered by AI

Is it possible to enroll in this clinical trial at present?

"According to the data found on clinicaltrials.gov, this particular medical experiment is not currently admitting participants. The initial post date was August 31st 2023 and it has since been edited as of May 23rd 2023. Although this trial does not require volunteers right now, there are numerous other studies recruiting at present with a total of 1482 openings for individuals to participate in."

Answered by AI

To what end is this research endeavor striving?

"According to the study's sponsor, Janssen Research & Development, LLC, this clinical trial will be gauging its efficacy by evaluating Percent Change From Randomization in Severity of Adjusted Hot Flash Score at 18 Months over an interval. Secondary outcomes such as Second Progression-free Survival (PFS2), Overall Survival (OS) and Prostate cancer-specific Survival will also be assessed."

Answered by AI

Who else is applying?

What site did they apply to?
Memorial Sloan Kettering Cancer Center
Associated Medical Professionals
Urology Associates
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC
2023. "A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05884398.
All > Penicillin Allergy > Tucson
~222 spots leftby May 2027
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