Back to resultsA Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC (LIBERTAS)
Primary Purpose
Metastatic Castrate-sensitive Prostate Cancer
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Apalutamide
Androgen-deprivation Therapy (ADT)
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Castrate-sensitive Prostate Cancer
Eligibility Criteria
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
Sites / Locations
- Colorado Clinical ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm A (Intermittent ADT Group)
Arm B (Continuous ADT Group)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
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.
Secondary Outcome Measures
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.
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.
Overall Survival (OS)
Overall survival time is defined as the duration from the date of randomization to the date of death from any cause.
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.
Serum Prostate Specific Antigen (PSA) Evaluations
Serum PSA evaluations will be measured according to Prostate Cancer Working Group 3 (PCWG3) criteria.
Duration of Time on Androgen-deprivation Therapy (ADT)
Duration of time on ADT will be reported for all participants.
Time to First ADT Restart
Time to first ADT restart will be reported.
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.
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.
Time to Recovery of Testosterone Greater Than or Equal (>=) Screening Testosterone Level
Time to recovery of testosterone >= screening testosterone level will be reported.
Time to Testosterone Recovery to Normal Range (>270 ng/dL)
Time to serum testosterone recovery to normal range (>270 ng/dL) will be reported.
Time to Metastatic Castration-resistant Prostate Cancer (mCRPC)
Time to mCRPC will be reported.
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.
Number of Participants with Abnormal Clinical Laboratory Parameters
Number of participants with abnormal clinical laboratory parameters (hematology, clinical chemistry) will be reported.
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.
Number of Participants with Abnormal Physical Examination Parameters
Number of Participants with Abnormal physical examination parameters will be reported.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05884398
First Posted
May 23, 2023
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
1. Study Identification
Unique Protocol Identification Number
NCT05884398
Brief Title
A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC
Acronym
LIBERTAS
Official 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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 31, 2023 (Actual)
Primary Completion Date
May 31, 2027 (Anticipated)
Study Completion Date
May 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Castrate-sensitive Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
333 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A (Intermittent ADT Group)
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm B (Continuous ADT Group)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Apalutamide
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Androgen-deprivation Therapy (ADT)
Intervention Description
The choice of ADT will be at discretion of the Investigator. Dosing (dose and frequency of administration) will be consistent with the prescribing information.
Primary Outcome Measure Information:
Title
Percentage of Participants With 18-Months Radiographic Progression-free Survival (rPFS)
Description
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).
Time Frame
From randomization (Day 1 of Cycle 7) up to 18 months
Title
Percent Change From Randomization in Severity of Adjusted Hot Flash Score at 18 Months
Description
Severity adjusted hot flash score will be calculated from the hot flash diary which will be daily filled by the participants.
Time Frame
From randomization (Day 1 of Cycle 7) up to 18 months
Secondary Outcome Measure Information:
Title
Mean Percentage Changes From Randomization in Severity Adjusted Hot Flash Score and Hot Flash Frequency
Description
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.
Time Frame
From randomization (Day 1 of Cycle 7), up to 3 years 3 months
Title
Second Progression-free Survival (PFS2)
Description
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.
Time Frame
From randomization (Day 1 of Cycle 7) up to 3 years 3 months
Title
Overall Survival (OS)
Description
Overall survival time is defined as the duration from the date of randomization to the date of death from any cause.
Time Frame
From randomization (Day 1 of Cycle 7) up to 3 years 3 months
Title
Prostate Cancer-specific Survival
Description
Prostate cancer-specific survival is defined as the duration from the date of randomization to the date of death from any cause.
Time Frame
From randomization (Day 1 Cycle 7) up to 3 years 3 months
Title
Serum Prostate Specific Antigen (PSA) Evaluations
Description
Serum PSA evaluations will be measured according to Prostate Cancer Working Group 3 (PCWG3) criteria.
Time Frame
From randomization (Day 1 of Cycle 7) up to 3 years 3 months
Title
Duration of Time on Androgen-deprivation Therapy (ADT)
Description
Duration of time on ADT will be reported for all participants.
Time Frame
From randomization (Day 1 of Cycle 7) up to 3 years 3 months
Title
Time to First ADT Restart
Description
Time to first ADT restart will be reported.
Time Frame
From randomization (Day 1 of Cycle 7) up to 3 years 3 months
Title
Duration of Time with Testosterone Level Less than (<) 50 nanograms per millilitre (ng/mL)
Description
Duration of time with testosterone level <50 ng/mL will be reported.
Time Frame
From randomization (Day 1 of Cycle 7) up to 3 years 3 months
Title
Time to Recovery of Testosterone >50 nanogram per decilitre (ng/dL)
Description
The testosterone recovery, defined as a serum testosterone >50 ng/dL will be analyzed.
Time Frame
From randomization (Day 1 of Cycle 7) up to 3 years 3 months
Title
Time to Recovery of Testosterone Greater Than or Equal (>=) Screening Testosterone Level
Description
Time to recovery of testosterone >= screening testosterone level will be reported.
Time Frame
From randomization (Day 1 of Cycle 7) up to 3 years 3 months
Title
Time to Testosterone Recovery to Normal Range (>270 ng/dL)
Description
Time to serum testosterone recovery to normal range (>270 ng/dL) will be reported.
Time Frame
From randomization (Day 1 of Cycle 7) up to 3 years 3 months
Title
Time to Metastatic Castration-resistant Prostate Cancer (mCRPC)
Description
Time to mCRPC will be reported.
Time Frame
From randomization (Day 1 of Cycle 7) up to 3 years 3 months
Title
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
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.
Time Frame
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)
Title
Number of Participants with Abnormal Clinical Laboratory Parameters
Description
Number of participants with abnormal clinical laboratory parameters (hematology, clinical chemistry) will be reported.
Time Frame
From Cycle 1 Day 1 up to 3 years 9 months
Title
Number of Participants with Abnormal Vital Sign Parameters
Description
Number of participants with abnormal vital sign parameters (temperature, pulse/heart rate, respiratory rate, and blood pressure) will be reported.
Time Frame
From Cycle 1 Day 1 up to 3 years 9 months
Title
Number of Participants with Abnormal Physical Examination Parameters
Description
Number of Participants with Abnormal physical examination parameters will be reported.
Time Frame
From Cycle 1 Day 1 up to 3 years 9 months
Title
Hot Flash Related Daily Interference Score (HFRDIS)
Description
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.
Time Frame
Up to 3 years 9 months
Title
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score
Description
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.
Time Frame
Baseline up to 3 years 9 months
Title
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire -Prostate Cancer Module (EORTC-PR25) Questionnaire
Description
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.
Time Frame
Baseline up to 3 years 9 months
Title
Change From Baseline in European Organization for the Research and Treatment of Cancer (EORTC) Customized Study Form
Description
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.
Time Frame
Baseline up to 3 years 9 months
Title
Change From Baseline in Patient-Reported Outcomes Measurement Information System Cognitive Function (PROMIS-Cog) Questionnaire
Description
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.
Time Frame
Baseline up to 3 years 9 months
Title
Change From Baseline in Memorial Anxiety Scale for Prostate Cancer (MAX-PC) Questionnaire
Description
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.
Time Frame
Baseline up to 3 years 9 months
Title
Change From Baseline in Patient Health Questionnaire (PHQ-9) Questionnaire
Description
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.
Time Frame
Baseline up to 3 years 9 months
Title
Change From Baseline in Patient Global Impression of Severity scale (PGIS) Questionnaire
Description
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.
Time Frame
Baseline up to 3 years 9 months
Title
Change From Baseline in Patient Global Impression of Change (PGIC) Questionnaire
Description
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.
Time Frame
Baseline up to 3 years 9 months
Title
Time to Recovery From Baseline as Assessed by EORTC-QLQ-C30
Description
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.
Time Frame
Baseline up to 3 years 9 months
Title
Time to Recovery From Baseline as Assessed by EORTC-PR25
Description
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.
Time Frame
Baseline up to 3 years 9 months
Title
Time to Recovery From Baseline as Assessed by EORTC Customized Study Form
Description
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.
Time Frame
Baseline up to 3 years 9 months
Title
Time to Recovery From Baseline as Assessed by MAX-PC
Description
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.
Time Frame
Baseline up to 3 years 9 months
Title
Time to Recovery From Baseline as Assessed by PHQ-9
Description
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.
Time Frame
Baseline up to 3 years 9 months
Title
Time to Recovery From Baseline as Assessed by PGIS
Description
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.
Time Frame
Baseline up to 3 years 9 months
Title
Time to Recovery From Baseline as Assessed by PGIC
Description
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.
Time Frame
Baseline up to 3 years and 9 months
Title
Time to Recovery From Baseline as Assessed by PROMIS-Cog
Description
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.
Time Frame
Baseline up to 3 years 9 months
Title
Time to Deterioration in EORTC-QLQ-C30 Over Time
Description
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.
Time Frame
Up to 3 years 9 months
Title
Time to Deterioration in EORTC-PR25 Over Time
Description
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.
Time Frame
Up to 3 years 9 months
Title
Time to Deterioration in EORTC Customized Study Form Over Time
Description
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.
Time Frame
Up to 3 years 9 months
Title
Time to Deterioration as per PROMIS-Cog Questionnaire Over Time
Description
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.
Time Frame
Up to 3 years 9 months
Title
Time to Deterioration in MAX-PC Questionnaire Over Time
Description
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.
Time Frame
Up to 3 years 9 months
Title
Time to Deterioration as per PHQ-9 Questionnaire Over Time
Description
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.
Time Frame
Up to 3 years 9 months
Title
Time to Deterioration in PGIS Questionnaire Over Time
Description
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.
Time Frame
Up to 3 years 9 months
Title
Time to Deterioration as per PGIC Questionnaire Over Time
Description
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.
Time Frame
Up to 3 years 9 months
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male assigned at birth, inclusive of all gender identities.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
844-434-4210
Email
Participate-In-This-Study@its.jnj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Colorado Clinical Research
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency
Learn more about this trial
A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC
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