A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC (LIBERTAS)

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)

The purpose of the study is to determine if the intermittent use of androgen-deprivation therapy (ADT) in participants with metastatic castrate-sensitive prostate cancer (mCSPC) who reached a prostate-specific antigen (PSA) level < 0.2 nanograms/millilitres (ng/mL) after 6 months of treatment with apalutamide and ADT combination therapy provides non-inferior radiographic progression-free survival (rPFS) and a reduced burden of hot flashes measured as 18-month percent change in severity adjusted hot flash score.

Study Overview

• Status: Recruiting
• Conditions: Metastatic Castrate-sensitive Prostate Cancer
• Intervention / Treatment: Drug: Apalutamide; Drug: Androgen-deprivation Therapy (ADT)

• Study Type: Interventional
• Enrollment (Estimated): 333
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study@its.jnj.com

Study Locations

• Australia
  • Macquarie University, Australia, 2109
    • Recruiting
    • Macquarie University Hospital
  • Melbourne, Australia, 3000
    • Recruiting
    • Peter MacCallum Cancer Centre
  • South Brisbane, Australia, 4101
    • Recruiting
    • Mater Misericordiae Hospital
• Brazil
  • Barretos, Brazil, 14784-400
    • Recruiting
    • Fundação PIO XII
  • Natal, Brazil, 59062-000
    • Recruiting
    • Liga Norte Riograndense Contra O Câncer
  • Salvador, Brazil, 41253 190
    • Recruiting
    • Instituto D Or de Pesquisa e Ensino
  • Santo André, Brazil, 09060-650
    • Recruiting
    • CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia
• Canada
  • Quebec, Canada, G1J 1Z4
    • Recruiting
    • CHU de Quebec Universite Laval Hopital de l Enfant Jesus
  • Alberta
    • Calgary, Alberta, Canada, T2V 1P9
      • Recruiting
      • Southern Alberta Institute of Urology / Prostate Cancer Centre
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Recruiting
      • Nova Scotia Health Authority
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Recruiting
      • Sunnybrook Health Sciences Center
    • Toronto, Ontario, Canada, M5G 2M9
      • Recruiting
      • Princess Margaret Hospital
• China
  • Beijing, China, 100034
    • Recruiting
    • Peking University First Hospital
  • Changchun, China, 130021
    • Recruiting
    • The First Hospital of Jilin University
  • Chengdu, China, 610041
    • Recruiting
    • West China School of Medicine/West China Hospital, Sichuan University
  • Guangzhou, China, 510080
    • Recruiting
    • The First Affiliated Hospital, Sun Yat-sen University
  • Guangzhou, China, 510515
    • Recruiting
    • Nanfang Hospital of Southern Medical Hospital
  • Jinan, China, 250021
    • Recruiting
    • Shandong Provincial Hospital
  • Ningbo, China, 315010
    • Recruiting
    • Ningbo First Hospital
  • Shenyang, China, 110004
    • Recruiting
    • ShengJing Hospital Of China Medical University
  • Wuhan, China, 430030
    • Recruiting
    • TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology
  • XI An, China, 710061
    • Recruiting
    • The First Affiliated Hospital of Xian Jiaotong University
• France
  • Lyon, France, 69373
    • Recruiting
    • Centre Léon Bérard
  • Paris, France, 75014
    • Recruiting
    • Hôpital COCHIN
  • Rennes, France, 35000
    • Recruiting
    • Chu Rennes Hopital Pontchaillou
  • Villejuif Cedex, France, 94805
    • Recruiting
    • Gustave Roussy
• Germany
  • Aachen, Germany, 52074
    • Recruiting
    • Universitaetsklinikum der RWTH Aachen
  • Augsburg, Germany, D-86158
    • Recruiting
    • Klinikum Augsburg
  • Dresden, Germany, 01307
    • Recruiting
    • Universitaetsklinikum Carl Gustav Carus TU Dresden
  • Koeln, Germany, 50937
    • Recruiting
    • Universitaetsklinikum Koelnt
  • Muenchen, Germany, 81675
    • Recruiting
    • Klinikum rechts der Isar - der Technischen Universität München
  • Nuertingen, Germany, 72622
    • Recruiting
    • Studienpraxis Urologie Nurtingen
  • Würzburg, Germany, 97080
    • Recruiting
    • Universitätsklinikum Würzburg
• Mexico
  • Chihuahua, Mexico, 31207
    • Recruiting
    • Scientia Investigacion Clinica SC
  • Queretaro, Mexico, 76000
    • Recruiting
    • Cuidados oncologicos
• Poland
  • Bydgoszcz, Poland, 85-796
    • Recruiting
    • Centrum Onkologii im. Prof. F. Lukaszczyka
  • Koszalin, Poland, 75-581
    • Recruiting
    • Szpital Wojewódzki im. Mikołaja Kopernika w Koszalinie
  • Warszawa, Poland, 04-073
    • Recruiting
    • Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o.
  • Warszawa, Poland, 02 781
    • Recruiting
    • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
  • Wroclaw, Poland, 53-329
    • Recruiting
    • Specjalistyczna przychodnia lekarska POLIMED
• United States
  • Alabama
    • Homewood, Alabama, United States, 35209
      • Recruiting
      • Urology Centers of Alabama
  • Arizona
    • Tucson, Arizona, United States, 85741
      • Recruiting
      • Arizona Urology Specialists
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Recruiting
      • Arkansas Urology
  • California
    • Santa Barbara, California, United States, 93105
      • Recruiting
      • Sansum Clinic Pharm
  • Colorado
    • Lakewood, Colorado, United States, 80228
      • Recruiting
      • Colorado Clinical Research
  • Florida
    • Daytona Beach, Florida, United States, 32114
      • Recruiting
      • Advanced Urology Institute
  • Illinois
    • Chicago Ridge, Illinois, United States, 60415
      • Recruiting
      • Associated Urological Specialists LLC
    • Joliet, Illinois, United States, 60431
      • Recruiting
      • Advanced Urology Associates
  • Indiana
    • Greenwood, Indiana, United States, 46143
      • Recruiting
      • Urology of Indiana
    • Jeffersonville, Indiana, United States, 47130
      • Recruiting
      • First Urology, PSC
  • Maryland
    • Silver Spring, Maryland, United States, 20904
      • Recruiting
      • Maryland Oncology Hematology P A
    • Towson, Maryland, United States, 21204
      • Recruiting
      • Chesapeake Urology Research Associates
  • Michigan
    • Troy, Michigan, United States, 48084
      • Recruiting
      • Michigan Institute of Urology
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Recruiting
      • MSKCC Basking Ridge
    • Middletown, New Jersey, United States, 07748
      • Recruiting
      • MSKCC Monmouth
    • Montvale, New Jersey, United States, 07645
      • Recruiting
      • MSKCC Bergen
  • New York
    • Commack, New York, United States, 11725
      • Recruiting
      • MSKCC Commack
    • Harrison, New York, United States, 10604
      • Recruiting
      • MSKCC Westchester
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Medical Center
    • Syracuse, New York, United States, 13210
      • Recruiting
      • Associated Medical Professionals
    • Uniondale, New York, United States, 11553
      • Recruiting
      • MSKCC Nassau Regional Cancer Center
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • Recruiting
      • TriState Urologic Services PSC Inc. DBA The Urology Group
    • Gahanna, Ohio, United States, 43230
      • Recruiting
      • Central Ohio Urology Group
    • Middleburg Heights, Ohio, United States, 44130
      • Recruiting
      • Helios Clinical Research, LLC
  • Oregon
    • Tigard, Oregon, United States, 97223
      • Recruiting
      • Northwest Cancer Specialists PC
  • Pennsylvania
    • Bala-Cynwyd, Pennsylvania, United States, 19004
      • Recruiting
      • Centers for Advanced Urology LLC d b a MidLantic Urology
    • Pittsburgh, Pennsylvania, United States, 15240
      • Recruiting
      • VA Pittsburgh
  • Tennessee
    • Nashville, Tennessee, United States, 37209
      • Recruiting
      • Urology Associates
  • Texas
    • Austin, Texas, United States, 78731
      • Recruiting
      • Texas Oncology P A
    • Dallas, Texas, United States, 75390
      • Recruiting
      • UT Southwestern Medical Center
    • Dallas, Texas, United States, 75246
      • Recruiting
      • Texas Oncology P.A.
    • Houston, Texas, United States, 77027
      • Recruiting
      • Houston Metro Urology
    • Houston, Texas, United States, 77024
      • Recruiting
      • Texas Oncology P.A.
    • San Antonio, Texas, United States, 78217
      • Recruiting
      • Texas Oncology San Antonio Northeast
    • Wichita Falls, Texas, United States, 76310
      • Recruiting
      • Texas Oncology P.A.
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Recruiting
      • Virginia Oncology Associates
    • Roanoke, Virginia, United States, 98684
      • Recruiting
      • Oncology and Hematology Associates of Southwest Virginia, Inc.
    • Virginia Beach, Virginia, United States, 23462
      • Recruiting
      • Urology of Virginia, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of prostate cancer prior to screening with histologically or cytologically confirmed adenocarcinoma of the prostate
• 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
• 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
• Participants who have undergone a bilateral orchidectomy and/or who are actively taking gender-affirming hormone therapy as part of their gender affirming care

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: 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.; Drug: 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.
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.	Drug: 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.; Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With 18-Months Radiographic Progression-free Survival (rPFS)	rPFS is defined as the duration from the date of randomization to the date of first documentation of confirmed radiographic progressive disease or death due to any cause, whichever occurs first. rPFS will be assessed by investigators using conventional imaging (computed tomography [CT]/magnetic resonance imaging [MRI] and 99mTc bone scans).	From randomization (Day 1 of Cycle 7) up to 18 months
Percent Change From Randomization in Severity of Adjusted Hot Flash Score at 18 Months	Severity adjusted hot flash score will be calculated from the hot flash diary which will be daily filled by the participants.	From randomization (Day 1 of Cycle 7) up to 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Percentage Changes From Randomization in Severity Adjusted Hot Flash Score and Hot Flash Frequency	Severity adjusted hot flash score and hot flash frequency will be calculated from the hot flash diary which will be daily filled by the participants.	From randomization (Day 1 of Cycle 7), up to 3 years 3 months
Second Progression-free Survival (PFS2)	PFS2 is defined as the duration from the date of randomization to the first occurrence of investigator-determined disease progression on the first subsequent therapy after study drug discontinuation or death, whichever occurs first.	From randomization (Day 1 of Cycle 7) up to 3 years 3 months
Overall Survival (OS)	Overall survival time is defined as the duration from the date of randomization to the date of death from any cause.	From randomization (Day 1 of Cycle 7) up to 3 years 3 months
Prostate Cancer-specific Survival	Prostate cancer-specific survival is defined as the duration from the date of randomization to the date of death from any cause.	From randomization (Day 1 Cycle 7) up to 3 years 3 months
Serum Prostate Specific Antigen (PSA) Evaluations	Serum PSA evaluations will be measured according to Prostate Cancer Working Group 3 (PCWG3) criteria.	From randomization (Day 1 of Cycle 7) up to 3 years 3 months
Duration of Time on Androgen-deprivation Therapy (ADT)	Duration of time on ADT will be reported for all participants.	From randomization (Day 1 of Cycle 7) up to 3 years 3 months
Time to First ADT Restart	Time to first ADT restart will be reported.	From randomization (Day 1 of Cycle 7) up to 3 years 3 months
Duration of Time with Testosterone Level Less than (<) 50 nanograms per millilitre (ng/mL)	Duration of time with testosterone level <50 ng/mL will be reported.	From randomization (Day 1 of Cycle 7) up to 3 years 3 months
Time to Recovery of Testosterone >50 nanogram per decilitre (ng/dL)	The testosterone recovery, defined as a serum testosterone >50 ng/dL will be analyzed.	From randomization (Day 1 of Cycle 7) up to 3 years 3 months
Time to Recovery of Testosterone Greater Than or Equal (>=) Screening Testosterone Level	Time to recovery of testosterone >= screening testosterone level will be reported.	From randomization (Day 1 of Cycle 7) up to 3 years 3 months
Time to Testosterone Recovery to Normal Range (>270 ng/dL)	Time to serum testosterone recovery to normal range (>270 ng/dL) will be reported.	From randomization (Day 1 of Cycle 7) up to 3 years 3 months
Time to Metastatic Castration-resistant Prostate Cancer (mCRPC)	Time to mCRPC will be reported.	From randomization (Day 1 of Cycle 7) up to 3 years 3 months
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect in the offspring of a participant, or is an important medical event.	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)
Number of Participants with Abnormal Clinical Laboratory Parameters	Number of participants with abnormal clinical laboratory parameters (hematology, clinical chemistry) will be reported.	From Cycle 1 Day 1 up to 3 years 9 months
Number of Participants with Abnormal Vital Sign Parameters	Number of participants with abnormal vital sign parameters (temperature, pulse/heart rate, respiratory rate, and blood pressure) will be reported.	From Cycle 1 Day 1 up to 3 years 9 months
Number of Participants with Abnormal Physical Examination Parameters	Number of Participants with Abnormal physical examination parameters will be reported.	From Cycle 1 Day 1 up to 3 years 9 months
Hot Flash Related Daily Interference Score (HFRDIS)	The HFRDIS is a 10-item scale assessing how much hot flashes interfered with various aspects of a participant's daily life. All items are rated on a 0-10 numerical rating scale with 0 anchored as "Do Not Interfere" and 10 as "Completely Interfere." A total score is computed by summing items. Higher scores indicate higher interference due to hot flashes and thus, greater impact on quality of life.	Up to 3 years 9 months
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score	The EORTC-QLQ-C30 (Version 3), is a self-administered, 30-item questionnaire measuring the HRQoL of participants with cancer. The recall period for most items is the past week. EORTC-QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea and vomiting), a global health status/quality of life scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The item and scale scores are transformed to a 0 to 100 scale. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high/healthy level of functioning and a high score for the global health status represents high HRQoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.	Baseline up to 3 years 9 months
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire -Prostate Cancer Module (EORTC-PR25) Questionnaire	The EORTC-PR25 questionnaire is a supplement to the EORTC-QLQ-C30 questionnaire and is designed to assess symptoms related to prostate cancer, its treatment, and aspects of life related to this type of cancer.	Baseline up to 3 years 9 months
Change From Baseline in European Organization for the Research and Treatment of Cancer (EORTC) Customized Study Form	EORTC customized study form will include 3 questions that are not included on the QLQ-30 or PR25 forms. The items assess rash, side effect burden, and dry mouth.	Baseline up to 3 years 9 months
Change From Baseline in Patient-Reported Outcomes Measurement Information System Cognitive Function (PROMIS-Cog) Questionnaire	The PROMIS-Cog is a self-administered fixed-length questionnaire of 8 items from the PROMIS item bank relating to cognitive function. The raw domain scores are converted to standardized T-scores with a mean of 50 and a standard deviation of 10. Higher scores indicate better cognitive functioning.	Baseline up to 3 years 9 months
Change From Baseline in Memorial Anxiety Scale for Prostate Cancer (MAX-PC) Questionnaire	The MAX-PC is a patient-reported questionnaire measuring prostate cancer specific anxiety. It consists of 18 items in 3 domains: It includes 11 items regarding prostate cancer anxiety, scored 0-33; 3 items regarding prostate-specific Antigen Anxiety, scored 0-9; and 4 items regarding fear of recurrence, scored 0-12. Total score ranges from 0-54 with higher scores indicating greater anxiety.	Baseline up to 3 years 9 months
Change From Baseline in Patient Health Questionnaire (PHQ-9) Questionnaire	The PHQ-9 is self-administered, 9-item questionnaire measuring symptoms of depression. The recall period for all items is the past 2 weeks. The items include diminished interest or pleasure, depressed mood, insomnia/hypersomnia, fatigue or loss of energy, weight loss or weight gain/appetite loss or appetite gain, feelings of worthlessness, diminished concentration/indecisiveness, psychomotor agitation/retardation, and thoughts of death/suicide. Higher scores indicate more severe depressive symptoms.	Baseline up to 3 years 9 months
Change From Baseline in Patient Global Impression of Severity scale (PGIS) Questionnaire	The PGIS is a self-administered, single item questionnaire measuring patients' impression of disease severity. Participants will be asked to rate their disease severity over the past 7 days using the following 5-point scale: 1 = None, 2 = Mild, 3 = Moderate, 4 = Severe, and 5 = Very severe. Higher scores indicate greater severity of fatigue.	Baseline up to 3 years 9 months
Change From Baseline in Patient Global Impression of Change (PGIC) Questionnaire	The PGIC is self-administered, single-item questionnaire measuring patients' impression of change in disease symptoms. Participants will be asked to rate their current symptoms as compared to when they started the study, using the following 7-point scale: 1 = Much better, 2 = Moderately better, 3 = A little better, 4 = No change, 5 = A little worse, 6 = Moderately worse, and 7 = Much worse. A higher PGIC score indicates greater worsening of symptoms.	Baseline up to 3 years 9 months
Time to Recovery From Baseline as Assessed by EORTC-QLQ-C30	Time to recovery from baseline as assessed by EORTC-QLQ-C30 will be reported. The EORTC-QLQ-C30 (Version 3), is a self-administered, 30-item questionnaire measuring the HRQoL of participants with cancer. The recall period for most items is the past week. EORTC-QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea and vomiting), a global health status/quality of life scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The item and scale scores are transformed to a 0 to 100 scale. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high/healthy level of functioning and a high score for the global health status represents high HRQoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.	Baseline up to 3 years 9 months
Time to Recovery From Baseline as Assessed by EORTC-PR25	Time to recovery from baseline as assessed by EORTC-PR25 will be reported. The EORTC-PR25 questionnaire is a supplement to the EORTC-QLQ-C30 questionnaire and is designed to assess symptoms related to prostate cancer, its treatment, and aspects of life related to this type of cancer.	Baseline up to 3 years 9 months
Time to Recovery From Baseline as Assessed by EORTC Customized Study Form	Time to recovery from baseline as assessed by EORTC customized study form will be reported. EORTC customized study form will include 3 questions that are not included on the QLQ-30 or PR25 forms. The items assess rash, side effect burden, and dry mouth.	Baseline up to 3 years 9 months
Time to Recovery From Baseline as Assessed by MAX-PC	Time to recovery from baseline as assessed by MAX-PC will be reported. The MAX-PC is a patient-reported questionnaire measuring prostate cancer specific anxiety. It consists of 18 items in 3 domains: It includes 11 items regarding prostate cancer anxiety, scored 0-33; 3 items regarding prostate-specific Antigen Anxiety, scored 0-9; and 4 items regarding fear of recurrence, scored 0-12. Total score ranges from 0-54 with higher scores indicating greater anxiety.	Baseline up to 3 years 9 months
Time to Recovery From Baseline as Assessed by PHQ-9	Time to recovery from baseline as assessed by PHQ-9 will be reported. The PHQ-9 is self-administered, 9-item questionnaire measuring symptoms of depression. The recall period for all items is the past 2 weeks. The items include diminished interest or pleasure, depressed mood, insomnia/hypersomnia, fatigue or loss of energy, weight loss or weight gain/appetite loss or appetite gain, feelings of worthlessness, diminished concentration/indecisiveness, psychomotor agitation/retardation, and thoughts of death/suicide. Higher scores indicate more severe depressive symptoms.	Baseline up to 3 years 9 months
Time to Recovery From Baseline as Assessed by PGIS	Time to recovery from baseline as assessed by PGIS will be reported. The PGIS is a self-administered, single item questionnaire measuring patients' impression of disease severity. Participants will be asked to rate their disease severity over the past 7 days using the following 5-point scale: 1 = None, 2 = Mild, 3 = Moderate, 4 = Severe, and 5 = Very severe. Higher scores indicate greater severity of fatigue.	Baseline up to 3 years 9 months
Time to Recovery From Baseline as Assessed by PROMIS-Cog	Time to recovery from baseline as assessed by PROMIS-Cog will be reported. The PROMIS-Cog is a self-administered fixed-length questionnaire of 8 items from the PROMIS item bank relating to cognitive function. The raw domain scores are converted to standardized T-scores with a mean of 50 and a standard deviation of 10. Higher scores indicate better cognitive functioning.	Baseline up to 3 years 9 months
Time to Deterioration in EORTC-QLQ-C30 Over Time	Time to deterioration in EORTC-QLQ-C30 over time will be reported. The EORTC-QLQ-C30 (Version 3), is a self-administered, 30-item questionnaire measuring the HRQoL of participants with cancer. The recall period for most items is the past week. EORTC-QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea and vomiting), a global health status/quality of life scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The item and scale scores are transformed to a 0 to 100 scale. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high/healthy level of functioning and a high score for the global health status represents high HRQoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.	Up to 3 years 9 months
Time to Deterioration in EORTC-PR25 Over Time	Time to deterioration in EORTC-PR25 over time will be reported. The EORTC-PR25 questionnaire is a supplement to the EORTC-QLQ-C30 questionnaire and is designed to assess symptoms related to prostate cancer, its treatment, and aspects of life related to this type of cancer.	Up to 3 years 9 months
Time to Deterioration in EORTC Customized Study Form Over Time	Time to deterioration in EORTC Customized Study Form over time will be reported. EORTC customized study form will include 3 questions that are not included on the QLQ-30 or PR25 forms. The items assess rash, side effect burden, and dry mouth.	Up to 3 years 9 months
Time to Deterioration as per PROMIS-Cog Questionnaire Over Time	Time to deterioration as per PROMIS-Cog questionnaire over time will be reported. The PROMIS-Cog is a self-administered fixed-length questionnaire of 8 items from the PROMIS item bank relating to cognitive function. The raw domain scores are converted to standardized T-scores with a mean of 50 and a standard deviation of 10. Higher scores indicate better cognitive functioning.	Up to 3 years 9 months
Time to Deterioration in MAX-PC Questionnaire Over Time	Time to deterioration in MAX-PC questionnaire over time will be reported. The MAX-PC is a patient-reported questionnaire measuring prostate cancer specific anxiety. It consists of 18 items in 3 domains: It includes 11 items regarding prostate cancer anxiety, scored 0-33; 3 items regarding prostate-specific Antigen Anxiety, scored 0-9; and 4 items regarding fear of recurrence, scored 0-12. Total score ranges from 0-54 with higher scores indicating greater anxiety.	Up to 3 years 9 months
Time to Deterioration as per PHQ-9 Questionnaire Over Time	Time to deterioration as per PHQ-9 questionnaire over time will be reported. The PHQ-9 is self-administered, 9-item questionnaire measuring symptoms of depression. The recall period for all items is the past 2 weeks. The items include diminished interest or pleasure, depressed mood, insomnia/hypersomnia, fatigue or loss of energy, weight loss or weight gain/appetite loss or appetite gain, feelings of worthlessness, diminished concentration/indecisiveness, psychomotor agitation/retardation, and thoughts of death/suicide. Higher scores indicate more severe depressive symptoms.	Up to 3 years 9 months
Time to Deterioration in PGIS Questionnaire Over Time	Time to deterioration as per PGIS questionnaire over time will be reported. The PGIS is a self-administered, single item questionnaire measuring patients' impression of disease severity. Participants will be asked to rate their disease severity over the past 7 days using the following 5-point scale: 1 = None, 2 = Mild, 3 = Moderate, 4 = Severe, and 5 = Very severe. Higher scores indicate greater severity of fatigue.	Up to 3 years 9 months
Time to Deterioration as per PGIC Questionnaire Over Time	Time to Deterioration as per PGIC questionnaire over time will be reported. The PGIC is self-administered, single-item questionnaire measuring patients' impression of change in disease symptoms. Participants will be asked to rate their current symptoms as compared to when they started the study, using the following 7-point scale: 1 = Much better, 2 = Moderately better, 3 = A little better, 4 = No change, 5 = A little worse, 6 = Moderately worse, and 7 = Much worse. A higher PGIC score indicates greater worsening of symptoms.	Up to 3 years 9 months
Time to Recovery From Baseline as Assessed by PGIC	Time to recovery from baseline as assessed by PGIC will be reported. The PGIC is self-administered, single-item questionnaire measuring patients' impression of change in disease symptoms. Participants will be asked to rate their current symptoms as compared to when they started the study, using the following 7-point scale: 1 = Much better, 2 = Moderately better, 3 = A little better, 4 = No change, 5 = A little worse, 6 = Moderately worse, and 7 = Much worse. A higher PGIC score indicates greater worsening of symptoms.	Baseline up to 3 years and 9 months

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2023
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: May 23, 2023
• First Submitted That Met QC Criteria: May 23, 2023
• First Posted (Actual): June 1, 2023

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Hypersensitivity; Prostatic Neoplasms; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Androgens
• Other Study ID Numbers: CR109327; 56021927PCR3020 (Other Identifier: Janssen Research & Development, LLC); 2022-502686-24-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No