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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05884398




Registration number
NCT05884398
Ethics application status
Date submitted
23/05/2023
Date registered
1/06/2023

Titles & IDs
Public title
A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC
Scientific title
A Phase 3, Open-label, Randomized, Prospective Study of Apalutamide With Continued Versus Intermittent Androgen-Deprivation Therapy (ADT) Following PSA Response in Participants With Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
Secondary ID [1] 0 0
56021927PCR3020
Secondary ID [2] 0 0
CR109327
Universal Trial Number (UTN)
Trial acronym
LIBERTAS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Castrate-sensitive Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate
Inflammatory and Immune System 0 0 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Apalutamide
Treatment: Drugs - Androgen-deprivation Therapy (ADT)

Experimental: Arm A (Intermittent ADT Group) - 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.

Experimental: Arm B (Continuous ADT Group) - 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.


Treatment: Drugs: Apalutamide
Apalutamide will be administered orally from Day 1 of Cycle 1 till 6 months in initial treatment phase and then in main treatment phase from Day 1 of Cycle 7 up to at least 18 months.

Treatment: Drugs: Androgen-deprivation Therapy (ADT)
The choice of ADT will be at discretion of the Investigator. Dosing (dose and frequency of administration) will be consistent with the prescribing information.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With 18-Months Radiographic Progression-free Survival (rPFS)
Timepoint [1] 0 0
From randomization (Day 1 of Cycle 7) up to 18 months
Primary outcome [2] 0 0
Percent Change From Randomization in Severity of Adjusted Hot Flash Score at 18 Months
Timepoint [2] 0 0
From randomization (Day 1 of Cycle 7) up to 18 months
Secondary outcome [1] 0 0
Mean Percentage Changes From Randomization in Severity Adjusted Hot Flash Score and Hot Flash Frequency
Timepoint [1] 0 0
From randomization (Day 1 of Cycle 7), up to 3 years 3 months
Secondary outcome [2] 0 0
Second Progression-free Survival (PFS2)
Timepoint [2] 0 0
From randomization (Day 1 of Cycle 7) up to 3 years 3 months
Secondary outcome [3] 0 0
Overall Survival (OS)
Timepoint [3] 0 0
From randomization (Day 1 of Cycle 7) up to 3 years 3 months
Secondary outcome [4] 0 0
Prostate Cancer-specific Survival
Timepoint [4] 0 0
From randomization (Day 1 Cycle 7) up to 3 years 3 months
Secondary outcome [5] 0 0
Serum Prostate Specific Antigen (PSA) Evaluations
Timepoint [5] 0 0
From randomization (Day 1 of Cycle 7) up to 3 years 3 months
Secondary outcome [6] 0 0
Duration of Time on Androgen-deprivation Therapy (ADT)
Timepoint [6] 0 0
From randomization (Day 1 of Cycle 7) up to 3 years 3 months
Secondary outcome [7] 0 0
Time to First ADT Restart
Timepoint [7] 0 0
From randomization (Day 1 of Cycle 7) up to 3 years 3 months
Secondary outcome [8] 0 0
Duration of Time with Testosterone Level Less than (<) 50 nanograms per millilitre (ng/mL)
Timepoint [8] 0 0
From randomization (Day 1 of Cycle 7) up to 3 years 3 months
Secondary outcome [9] 0 0
Time to Recovery of Testosterone >50 nanogram per decilitre (ng/dL)
Timepoint [9] 0 0
From randomization (Day 1 of Cycle 7) up to 3 years 3 months
Secondary outcome [10] 0 0
Time to Recovery of Testosterone Greater Than or Equal (>=) Screening Testosterone Level
Timepoint [10] 0 0
From randomization (Day 1 of Cycle 7) up to 3 years 3 months
Secondary outcome [11] 0 0
Time to Testosterone Recovery to Normal Range (>270 ng/dL)
Timepoint [11] 0 0
From randomization (Day 1 of Cycle 7) up to 3 years 3 months
Secondary outcome [12] 0 0
Time to Metastatic Castration-resistant Prostate Cancer (mCRPC)
Timepoint [12] 0 0
From randomization (Day 1 of Cycle 7) up to 3 years 3 months
Secondary outcome [13] 0 0
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [13] 0 0
Initial Treatment Phase: From Day 1 of Cycle 1 (each cycle 28 days) up to end of Cycle 6 (6 month); Main Treatment Phase: Day 1 of Cycle 7 up to end of study (up to 3 years 9 months)
Secondary outcome [14] 0 0
Number of Participants with Abnormal Clinical Laboratory Parameters
Timepoint [14] 0 0
From Cycle 1 Day 1 up to 3 years 9 months
Secondary outcome [15] 0 0
Number of Participants with Abnormal Vital Sign Parameters
Timepoint [15] 0 0
From Cycle 1 Day 1 up to 3 years 9 months
Secondary outcome [16] 0 0
Number of Participants with Abnormal Physical Examination Parameters
Timepoint [16] 0 0
From Cycle 1 Day 1 up to 3 years 9 months
Secondary outcome [17] 0 0
Hot Flash Related Daily Interference Score (HFRDIS)
Timepoint [17] 0 0
Up to 3 years 9 months
Secondary outcome [18] 0 0
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score
Timepoint [18] 0 0
Baseline up to 3 years 9 months
Secondary outcome [19] 0 0
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire -Prostate Cancer Module (EORTC-PR25) Questionnaire
Timepoint [19] 0 0
Baseline up to 3 years 9 months
Secondary outcome [20] 0 0
Change From Baseline in European Organization for the Research and Treatment of Cancer (EORTC) Customized Study Form
Timepoint [20] 0 0
Baseline up to 3 years 9 months
Secondary outcome [21] 0 0
Change From Baseline in Patient-Reported Outcomes Measurement Information System Cognitive Function (PROMIS-Cog) Questionnaire
Timepoint [21] 0 0
Baseline up to 3 years 9 months
Secondary outcome [22] 0 0
Change From Baseline in Memorial Anxiety Scale for Prostate Cancer (MAX-PC) Questionnaire
Timepoint [22] 0 0
Baseline up to 3 years 9 months
Secondary outcome [23] 0 0
Change From Baseline in Patient Health Questionnaire (PHQ-9) Questionnaire
Timepoint [23] 0 0
Baseline up to 3 years 9 months
Secondary outcome [24] 0 0
Change From Baseline in Patient Global Impression of Severity scale (PGIS) Questionnaire
Timepoint [24] 0 0
Baseline up to 3 years 9 months
Secondary outcome [25] 0 0
Change From Baseline in Patient Global Impression of Change (PGIC) Questionnaire
Timepoint [25] 0 0
Baseline up to 3 years 9 months
Secondary outcome [26] 0 0
Time to Recovery From Baseline as Assessed by EORTC-QLQ-C30
Timepoint [26] 0 0
Baseline up to 3 years 9 months
Secondary outcome [27] 0 0
Time to Recovery From Baseline as Assessed by EORTC-PR25
Timepoint [27] 0 0
Baseline up to 3 years 9 months
Secondary outcome [28] 0 0
Time to Recovery From Baseline as Assessed by EORTC Customized Study Form
Timepoint [28] 0 0
Baseline up to 3 years 9 months
Secondary outcome [29] 0 0
Time to Recovery From Baseline as Assessed by MAX-PC
Timepoint [29] 0 0
Baseline up to 3 years 9 months
Secondary outcome [30] 0 0
Time to Recovery From Baseline as Assessed by PHQ-9
Timepoint [30] 0 0
Baseline up to 3 years 9 months
Secondary outcome [31] 0 0
Time to Recovery From Baseline as Assessed by PGIS
Timepoint [31] 0 0
Baseline up to 3 years 9 months
Secondary outcome [32] 0 0
Time to Recovery From Baseline as Assessed by PGIC
Timepoint [32] 0 0
Baseline up to 3 years and 9 months
Secondary outcome [33] 0 0
Time to Recovery From Baseline as Assessed by PROMIS-Cog
Timepoint [33] 0 0
Baseline up to 3 years 9 months
Secondary outcome [34] 0 0
Time to Deterioration in EORTC-QLQ-C30 Over Time
Timepoint [34] 0 0
Up to 3 years 9 months
Secondary outcome [35] 0 0
Time to Deterioration in EORTC-PR25 Over Time
Timepoint [35] 0 0
Up to 3 years 9 months
Secondary outcome [36] 0 0
Time to Deterioration in EORTC Customized Study Form Over Time
Timepoint [36] 0 0
Up to 3 years 9 months
Secondary outcome [37] 0 0
Time to Deterioration as per PROMIS-Cog Questionnaire Over Time
Timepoint [37] 0 0
Up to 3 years 9 months
Secondary outcome [38] 0 0
Time to Deterioration in MAX-PC Questionnaire Over Time
Timepoint [38] 0 0
Up to 3 years 9 months
Secondary outcome [39] 0 0
Time to Deterioration as per PHQ-9 Questionnaire Over Time
Timepoint [39] 0 0
Up to 3 years 9 months
Secondary outcome [40] 0 0
Time to Deterioration in PGIS Questionnaire Over Time
Timepoint [40] 0 0
Up to 3 years 9 months
Secondary outcome [41] 0 0
Time to Deterioration as per PGIC Questionnaire Over Time
Timepoint [41] 0 0
Up to 3 years 9 months

Eligibility
Key inclusion criteria
* Diagnosis of prostate cancer prior to screening with histologically or cytologically confirmed adenocarcinoma of the prostate
* For participants not undergoing Gender-affirming care: 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
* For participants undergoing Gender-affirming care: No evidence of metastasis by either conventional imaging (example, CT, MRI, or bone scan) and/or NGI is also acceptable
* For participants not undergoing gender-affirming care: testosterone levels > 50 (ng/dL) nanograms per deciliter at screening, except for those who may have received ADT prior to screening. Participants are allowed to have received up to 3 months of (ADT) androgen-deprivation therapy prior to enrollment
* For participants undergoing Gender-affirming care: There is no testosterone level requirement for inclusion
* Have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. Participants with ECOG PS 2 or 3 are eligible for the study if the ECOG PS score is related to stable physical limitations (example, wheelchair-bound due to prior spinal cord injury) and not related to prostate cancer or associated therapy
* A participant must agree not to plan to conceive a child while enrolled in this study or within 3 months after the last dose of study treatment
* Must be able to take whole apalutamide tablets by swallowing alone or with another vehicle (example, applesauce)
* Assigned male at birth, inclusive of all gender identities
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* History of seizure or known condition that has been determined to significantly predispose to seizure per investigator
* Pelvic lymph nodes as only site of metastasis
* Known allergies, hypersensitivity, or intolerance to excipients of apalutamide
* 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
* Gastrointestinal disorder affecting absorption
* Participants who have undergone a bilateral orchiectomy with the exception of participants who completed this as part of their gender-affirming care or a result of a variation in physical sex development

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/08/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
14/04/2027
Actual
Sample size
Target
420
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Macquarie University Hospital - Macquarie University
Recruitment hospital [2] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [3] 0 0
Mater Misericordiae Hospital - South Brisbane
Recruitment postcode(s) [1] 0 0
2109 - Macquarie University
Recruitment postcode(s) [2] 0 0
3000 - Melbourne
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
New Jersey
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oregon
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
Tennessee
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Utah
Country [19] 0 0
United States of America
State/province [19] 0 0
Virginia
Country [20] 0 0
Brazil
State/province [20] 0 0
Barretos
Country [21] 0 0
Brazil
State/province [21] 0 0
Belo Horizonte
Country [22] 0 0
Brazil
State/province [22] 0 0
Natal
Country [23] 0 0
Brazil
State/province [23] 0 0
Rio de Janeiro
Country [24] 0 0
Brazil
State/province [24] 0 0
Salvador
Country [25] 0 0
Brazil
State/province [25] 0 0
Santo André
Country [26] 0 0
Brazil
State/province [26] 0 0
São Paulo
Country [27] 0 0
Canada
State/province [27] 0 0
Alberta
Country [28] 0 0
Canada
State/province [28] 0 0
Nova Scotia
Country [29] 0 0
Canada
State/province [29] 0 0
Ontario
Country [30] 0 0
Canada
State/province [30] 0 0
Quebec
Country [31] 0 0
China
State/province [31] 0 0
Changchun
Country [32] 0 0
China
State/province [32] 0 0
Chengdu
Country [33] 0 0
China
State/province [33] 0 0
Guangzhou
Country [34] 0 0
China
State/province [34] 0 0
Jinan
Country [35] 0 0
China
State/province [35] 0 0
Ningbo
Country [36] 0 0
China
State/province [36] 0 0
Shenyang
Country [37] 0 0
China
State/province [37] 0 0
Wuhan
Country [38] 0 0
China
State/province [38] 0 0
XI An
Country [39] 0 0
France
State/province [39] 0 0
Bordeaux
Country [40] 0 0
France
State/province [40] 0 0
Lyon
Country [41] 0 0
France
State/province [41] 0 0
Paris
Country [42] 0 0
France
State/province [42] 0 0
Rennes
Country [43] 0 0
France
State/province [43] 0 0
Villejuif Cedex
Country [44] 0 0
Germany
State/province [44] 0 0
Aachen
Country [45] 0 0
Germany
State/province [45] 0 0
Augsburg
Country [46] 0 0
Germany
State/province [46] 0 0
Dresden
Country [47] 0 0
Germany
State/province [47] 0 0
Koeln
Country [48] 0 0
Germany
State/province [48] 0 0
Lubeck
Country [49] 0 0
Germany
State/province [49] 0 0
Muenchen
Country [50] 0 0
Germany
State/province [50] 0 0
Nuertingen
Country [51] 0 0
Germany
State/province [51] 0 0
Würzburg
Country [52] 0 0
Mexico
State/province [52] 0 0
Chihuahua
Country [53] 0 0
Mexico
State/province [53] 0 0
Durango
Country [54] 0 0
Mexico
State/province [54] 0 0
Merida
Country [55] 0 0
Mexico
State/province [55] 0 0
Queretaro
Country [56] 0 0
Poland
State/province [56] 0 0
Bydgoszcz
Country [57] 0 0
Poland
State/province [57] 0 0
Koszalin
Country [58] 0 0
Poland
State/province [58] 0 0
Warszawa
Country [59] 0 0
Poland
State/province [59] 0 0
Wroclaw

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
Fax 0 0
Email 0 0
Participate-In-This-Study@its.jnj.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.janssen.com/clinical-trials/transparency


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05884398