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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

Must not have

Gastrointestinal disorder affecting absorption

Any of the following within 6 months prior to screening: severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, uncontrolled hypertension, clinically significant arterial or venous thromboembolic events

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years 9 months

Awards & highlights

No Placebo-Only Group

Pivotal 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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a digestive condition that affects how my body absorbs food.

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I haven't had severe heart issues or blood clots in the last 6 months.

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My cancer has spread only to the pelvic lymph nodes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years 9 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

~5750

Androgen-deprivation Therapy (ADT)

2019

N/A

~980