Medical inquiries

Connect with my medical science liaison

Chat live

Available Monday - Friday 9AM - 4:30PM ET

Call me now

Available Monday - Friday 9AM - 7:30PM ET

Email your inquiry

Call 1-800-526-7736

Available Monday - Friday 9AM - 8PM ET

Live video

Available Monday - Friday 9AM - 4:30PM ET

This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.

ERLEADA® (apalutamide)

Medical Information

+ Save link

ERLEADA – LIBERTAS Study

Last Updated: 02/21/2025

SUMMARY

LIBERTAS (NCT05884398) is an ongoing, phase 3, prospective, randomized, open-label, multicenter, global study evaluating the efficacy and safety of ERLEADA with intermittent vs continuous androgen deprivation therapy (ADT) following undetectable prostate-specific antigen (PSA) response (<0.2 ng/mL) in patients with newly diagnosed metastatic castration-sensitive prostate cancer (mCSPC), inclusive of all gender identities. After 6 months of initial treatment with ERLEADA and ADT, patients with PSA response enter the main treatment phase and will be treated with either ERLEADA and intermittent ADT or ERLEADA and continuous ADT. The coprimary endpoints are radiographic progression-free survival and hot flash severity score and frequency at 18 months from randomization.¹^-³
- The planned enrollment goal (~333 patients)¹^,² has been met, with 420 patients across 73 sites in 9 countries enrolled in the initial treatment phase as of September 20, 2024.⁴
- Initial PSA results after 3 and 6 months of ERLEADA and ADT treatment are reported below.⁴
- No new safety signals were observed; results have not been published.

CLINICAL DATA

LIBERTAS Study

LIBERTAS is an ongoing phase 3 study evaluating the efficacy and safety of ERLEADA with intermittent vs continuous ADT following PSA response in patients with newly diagnosed mCSPC, inclusive of all gender identities.¹^-³

Study Design/Methods

Phase 3, prospective, randomized, open-label, multicenter, global study (Figure: LIBERTAS Study Design).

LIBERTAS Study Design¹^-³

Abbreviations: ^99mTc, technetium-99m; ADT, androgen deprivation therapy; APA, apalutamide; CT, computed tomography; ECOG, Eastern Cooperative Oncology Group; GAC, gender-affirming care; LAPC, locally advanced prostate cancer; LPC, localized prostate cancer; mCRPC, metastatic castration-resistant prostate cancer; mCSPC, metastatic castration-sensitive prostate cancer; mCSPC, metastatic castration-sensitive prostate cancer; MRI, magnetic resonance imaging; NGI, next-generation imaging; OS, overall survival; PC, prostate cancer; PFS2, second progression-free survival; PS, performance status; PSA, prostate-specific antigen; PO, orally; PRO, patient-reported outcomes; PSA, prostate-specific antigen; QD, once daily; QoL, quality of life; R, randomization; rPFS, radiographic progression-free survival; SOC, standard of care.

^aPatient enrollment includes a degendered and transgender-inclusive protocol, as well as nonbinary and gender-diverse patients.

^b≤3 months of ADT prior to enrolment (except patients receiving ADT as part of their GAC).
^cPatients with ECOG PS 2-3 are eligible if the score is related to stable physical limitations (eg. spinal cord injury, blindness) and not related to prostate cancer or associated therapy.
^dSevere or unstable angina, myocardial infarction, symptomatic congestive heart failure, uncontrolled hypertension, clinically significant arterial or venous thromboembolic events.

^ePatients undergoing GAC or with a variation in physical development who receive exogenous hormones will be evaluated as a separate cohort with regard to their outcomes in a more descriptive manner. These patients will not be randomized for the main treatment phase and will be continuously treated with ERLEADA from study initiation until disease progression.
^fChoice of ADT (gonadotropin-releasing hormone agonist or antagonist) at discretion of investigator.
^gPatients in Arm A can restart ADT with new or worsening cancer symptoms, PSA increase to >10 ng/mL (or return to baseline level when PSA was <10 ng/mL before starting ADT) or PSA doubling time <6 months.
^hPatients with a PSA level <0.2 ng/mL after 6 months of treatment with ERLEADA and ADT during the initial treatment phase, will enter the main treatment phase.
ⁱConventional imaging (CT/MRI and ^99mTc bone scans) will be used for the assessment of radiographic progression.
^jQoL assessments will be based on subjective PROs and objective data from digital health tools. Hot flashes will be evaluated using the Hot Flash Related Daily Interference Scale PRO questionnaire.
^kFindings from digital health tools measure sleep, activity and neurocognitive function, and PROs, including physical and mental wellbeing.

Results

Patient Characteristics

The planned enrollment goal (~333 patients)¹^,² has been met. As of September 20, 2024, a total of 420 patients across 73 sites in 9 countries have been enrolled in the initial treatment phase.⁴
Baseline characteristics of enrolled and early randomized patients are shown in Table: Select Baseline Patient Characteristics.⁴
Of the 143 patients who completed the initial 6-month treatment phase, 98 patients were randomized to the main treatment phase (undetectable PSA level group).⁴
Enrollment is ongoing for patients undergoing GAC; no patients have enrolled yet.⁴

Select Baseline Patient Characteristics⁴

Characteristic	Enrolled Patients (N=420)	Randomized Patients^a (n=98)
Median age, years (range)	70 (48-88)	72 (51-86)
Gender identity, n (%)
Men	235 (56.0)	70 (71.4)
Not reported or declined to answer	185 (44.0)	28 (28.6)
Median time from diagnosis to randomization, months (range)	10.25 (6.1-271.1)	10.25 (6.1-271.1)
Race, n (%)
White	296 (70.5)	76 (77.6)
Asian	40 (9.5)	10 (10.2)
Black or African American	36 (8.6)	10 (10.2)
Other or multiple	33 (7.9)	2 (2.0)
Not reported or unknown	13 (3.1)	0
American Indian or Alaska Native	2 (0.5)	0
ECOG PS, n (%)
0	311 (74.0)	80 (81.6)
1	106 (25.2)	17 (17.3)
2	3 (0.7)	1 (1.0)
Gleason score at initial diagnosis, n (%)
≤7	139 (33.1)	34 (34.7)
>7	269 (64.0)	61 (62.2)
Missing	12 (2.9)	3 (3.1)
Metastasis stage at diagnosis, n (%)
M0 or MX	145 (34.5)	38 (38.8)
M1	274 (65.2)	60 (61.2)
Missing	1 (0.2)	0
Visceral metastases at study entry, n (%)	61 (14.5)	13 (13.3)
Liver metastases	8 (1.9)	1 (1.0)
Median baseline PSA, ng/mL (range)	7.32 (0.0-4433.0)	3.36 (0.0-1030.0)
Abbreviations: ECOG PS, Eastern Cooperative Oncology Group performance status; PSA, prostate-specific antigen.^aAs of November 4, 2024.

Initial Treatment Results

After 3 months of treatment with ERLEADA and ADT during the initial treatment phase, a rapid and deep decline in PSA levels was observed in most patients (Table: PSA Decline After 3 and 6 Months of Initial Treatment).⁴
The compliance rate for hot flash diary data completion consistently exceeded 80% at all visits. Hot flash incidence will be reported in the future with more mature data.⁴

PSA Decline After 3 and 6 Months of Initial Treatment⁴

PSA Levels	Treated Patients
PSA decline after 3 months of treatment, n (%)	N=420
≥50%^a	381 (90.7)
≥90%^a	259 (61.7)
<0.2 ng/mL	174 (41.4)
Median time to confirmed PSA decline after 3 months, months (range)
≥50%^a	1.87 (1.0-5.3)
≥90%^a	1.87 (1.1-5.6)
<0.2 ng/mL	2.76 (1.5-5.7)
PSA decline after 6 months of treatment, n (%)	n=143
≥50%^a	137 (95.8)
≥90%^a	113 (79.0)
<0.2 ng/mL	101 (70.6)
Abbreviation: PSA, prostate-specific antigen.^aDecline from baseline.

No new safety signals were observed; results have not been published.

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File (and/or other resources, including internal/external databases) was conducted on
12 February 2025.

References

Show

1	Azad A, Badillo MA, Dong Q, et al. Apalutamide plus intermittent versus continuous androgen deprivation therapy in participants with metastatic hormone-sensitive prostate cancer: LIBERTAS phase 3 study design. Poster presented at: 2024 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium; January 25-27, 2024; San Francisco, CA.
2	Azad A, Musto C, Netanel S, et al. LIBERTAS, a degendered and transgender-inclusive phase 3 study of apalutamide plus intermittent versus continuous androgen deprivation therapy in participants with metastatic hormone-sensitive prostate cancer. Poster presented at: 2024 American Society of Clinical Oncology (ASCO) Annual Meeting; May 31-June 4, 2024; Chicago, IL.
3	Janssen Research & Development, LLC. A study of an intermittent ADT approach with apalutamide monotherapy in participants with mCSPC (LIBERTAS). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2020- [cited 2024 May 30]. Available from: https://clinicaltrials.gov/study/NCT05884398 NLM Identifier: NCT05884398.
4	Azad A, Badillo MA, Dong Q, et al. Deep prostate-specific antigen decline among early participants in LIBERTAS, a phase 3 study of apalutamide plus continuous versus intermittent androgen deprivation therapy in metastatic castration-sensitive prostate cancer. Poster presented at: 2025 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium; February 13-15, 2025; San Francisco, CA.