Janssen Research & Development, LLC Clinical Trial Study Director Janssen Research & Development, LLC
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Study Contact Kontakt: Phone: 844-434-4210 E-Mail: Participate-In-This-Study@its.jnj.com» Kontaktdaten anzeigen
Studienlocations (3 von 85)
Universitaetsklinikum der RWTH Aachen 52074 Aachen GermanyRekrutierend» Google-MapsDarmzentrum Klinikum Augsburg Stenglinstraße 2 86156 Augsburg DeutschlandRekrutierend» Google-MapsUniversitaetsklinikum Carl Gustav Carus TU Dresden 01307 Dresden (Sachsen) GermanyRekrutierend» Google-Maps
Universitaetsklinikum Koelnt 50937 Koeln (Nordrhein-Westfalen) GermanyRekrutierend» Google-MapsKlinikum rechts der Isar - der Technischen Universität München 81675 Muenchen (Bayern) GermanyRekrutierend» Google-MapsStudienpraxis Urologie Nurtingen 72622 Nuertingen (Baden-Württemberg) GermanyRekrutierend» Google-MapsUniversitatsklinikum Wurzburg 97080 Würzburg (Bayern) GermanyRekrutierend» Google-MapsUrology Centers Of Alabama 35209 Homewood United StatesRekrutierend» Google-MapsArizona Urology Specialists 85741 Tucson United StatesRekrutierend» Google-MapsArkansas Urology 72211 Little Rock United StatesRekrutierend» Google-MapsSansum Clinic Pharm 93105 Santa Barbara United StatesRekrutierend» Google-MapsColorado Clinical Research 80228 Lakewood United StatesRekrutierend» Google-MapsAdvanced Urology Institute 32114 Daytona Beach United StatesRekrutierend» Google-MapsAssociated Urological Specialists LLC 60415 Chicago Ridge United StatesRekrutierend» Google-MapsAdvanced Urology Associates 60431 Joliet United StatesRekrutierend» Google-MapsUrology of Indiana 46143 Greenwood United StatesRekrutierend» Google-MapsFirst Urology, PSC 47130 Jeffersonville United StatesRekrutierend» Google-MapsMaryland Oncology Hematology P A 20904 Silver Spring United StatesRekrutierend» Google-MapsChesapeake Urology Research Associates 21204 Towson United StatesRekrutierend» Google-MapsMichigan Institute of Urology 48084 Troy United StatesRekrutierend» Google-MapsMSKCC Basking Ridge 07920 Basking Ridge United StatesRekrutierend» Google-MapsMSKCC Monmouth 07748 Middletown United StatesRekrutierend» Google-MapsMSKCC Bergen 07645 Montvale United StatesRekrutierend» Google-MapsMSKCC Commack 11725 Commack United StatesRekrutierend» Google-MapsMSKCC Westchester 10604 Harrison United StatesRekrutierend» Google-MapsColumbia University Medical Center 10032 New York United StatesRekrutierend» Google-MapsMemorial Sloan Kettering Cancer Center 10065 New York United StatesRekrutierend» Google-MapsAssociated Medical Professionals 13210 Syracuse United StatesRekrutierend» Google-MapsMSKCC Nassau Regional Cancer Center 11553 Uniondale United StatesRekrutierend» Google-MapsTriState Urologic Services PSC Inc. DBA The Urology Group 45212 Cincinnati United StatesRekrutierend» Google-MapsCentral Ohio Urology Group 43230 Gahanna United StatesRekrutierend» Google-MapsHelios Clinical Research, LLC 44130 Middleburg Heights United StatesRekrutierend» Google-MapsNorthwest Cancer Specialists PC 97223 Tigard United StatesRekrutierend» Google-MapsCenters for Advanced Urology LLC d b a MidLantic Urology 19004 Bala-Cynwyd United StatesRekrutierend» Google-MapsUniversity of Pittsburgh Medical Center 15232 Pittsburgh United StatesRekrutierend» Google-MapsVA Pittsburgh 15240 Pittsburgh United StatesRekrutierend» Google-MapsUrology Associates 37209 Nashville United StatesRekrutierend» Google-MapsTexas Oncology P A 78731 Austin United StatesRekrutierend» Google-MapsTexas Oncology P.A. 75246 Dallas United StatesRekrutierend» Google-MapsUT Southwestern Medical Center 75390 Dallas United StatesRekrutierend» Google-MapsTexas Oncology P.A. 77024 Houston United StatesRekrutierend» Google-MapsHouston Metro Urology 77027 Houston United StatesRekrutierend» Google-MapsTexas Oncology San Antonio Northeast 78217 San Antonio United StatesRekrutierend» Google-MapsTexas Oncology P.A. 76310 Wichita Falls United StatesRekrutierend» Google-MapsVirginia Oncology Associates 23502 Norfolk United StatesRekrutierend» Google-MapsOncology and Hematology Associates of Southwest Virginia, Inc. 98684 Roanoke United StatesRekrutierend» Google-MapsUrology Of Virginia, Pllc 23462 Virginia Beach United StatesRekrutierend» Google-MapsMacquarie University Hospital 2109 Macquarie University AustraliaRekrutierend» Google-MapsPeter MacCallum Cancer Centre 3000 Melbourne AustraliaRekrutierend» Google-MapsMater Misericordiae Hospital 4101 South Brisbane AustraliaRekrutierend» Google-MapsFundacao Pio XII 14784-400 Barretos BrazilRekrutierend» Google-MapsHospital das Clínicas - Universidade Federal de Minas Gerais 30130-100 Belo Horizonte BrazilRekrutierend» Google-MapsLiga Norte Riograndense Contra O Cancer 59062-000 Natal BrazilRekrutierend» Google-MapsMinisterio da Saude - Instituto Nacional do Cancer 20230-130 Rio de Janeiro BrazilRekrutierend» Google-MapsInstituto D Or de Pesquisa e Ensino 41253 190 Salvador BrazilRekrutierend» Google-MapsCEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia 09060-650 Santo André BrazilRekrutierend» Google-MapsSouthern Alberta Institute of Urology / Prostate Cancer Centre T2V 1P9 Calgary CanadaRekrutierend» Google-MapsNova Scotia Health Authority B3H 2Y9 Halifax CanadaRekrutierend» Google-MapsSunnybrook Health Sciences Center M4N 3M5 Toronto CanadaRekrutierend» Google-MapsPrincess Margaret Hospital M5G 2M9 Toronto CanadaRekrutierend» Google-MapsCHU de Quebec Universite Laval Hopital de l Enfant Jesus G1J 1Z4 Quebec CanadaRekrutierend» Google-MapsPeking University First Hospital 100034 Beijing ChinaRekrutierend» Google-MapsThe First Hospital of Jilin University 130021 Changchun ChinaRekrutierend» Google-MapsWest China School of Medicine/West China Hospital, Sichuan University 610041 Chengdu ChinaRekrutierend» Google-MapsThe First Affiliated Hospital, Sun Yat-sen University 510080 Guangzhou ChinaRekrutierend» Google-MapsNanfang Hospital of Southern Medical Hospital 510515 Guangzhou ChinaRekrutierend» Google-MapsShandong Provincial Hospital 250021 Jinan ChinaRekrutierend» Google-MapsNingbo First Hospital 315010 Ningbo ChinaRekrutierend» Google-MapsShengjing Hospital of China Medical University 110004 Shenyang ChinaRekrutierend» Google-MapsTongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology 430030 Wuhan ChinaRekrutierend» Google-MapsThe First Affiliated Hospital of Xian Jiaotong University 710061 XI An ChinaRekrutierend» Google-MapsInstitut Bergonié 33076 Bordeaux FranceRekrutierend» Google-MapsCentre Leon Berard 69373 Lyon FranceRekrutierend» Google-MapsHopital Cochin 75014 Paris FranceRekrutierend» Google-MapsChu Rennes Hopital Pontchaillou 35000 Rennes FranceRekrutierend» Google-MapsGustave Roussy 94805 Villejuif Cedex FranceRekrutierend» Google-MapsSCIENTIA Investigacion Clinica SC 31207 Chihuahua MexicoRekrutierend» Google-MapsConsultorio de Especialidad en Urologia Privado 34000 Durango MexicoRekrutierend» Google-MapsMedical Care & Research SA de CV 97070 Merida MexicoRekrutierend» Google-MapsCuidados Oncologicos 76000 Queretaro MexicoRekrutierend» Google-MapsCentrum Onkologii im. Prof. F. Lukaszczyka 85-796 Bydgoszcz PolandRekrutierend» Google-MapsSzpital Wojewódzki im. Mikołaja Kopernika w Koszalinie 75-581 Koszalin PolandRekrutierend» Google-MapsNarodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy 02 781 Warszawa PolandRekrutierend» Google-MapsSzpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o. 04-073 Warszawa PolandRekrutierend» Google-MapsSpecjalistyczna przychodnia lekarska POLIMED 53-329 Wroclaw PolandRekrutierend» Google-Maps
1. Percentage of Participants With 18-Months Radiographic Progression-free Survival (rPFS) (Time Frame - From randomization (Day 1 of Cycle 7) up to 18 months): 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).
2. Percent Change From Randomization in Severity of Adjusted Hot Flash Score at 18 Months (Time Frame - From randomization (Day 1 of Cycle 7) up to 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:
1. Mean Percentage Changes From Randomization in Severity Adjusted Hot Flash Score and Hot Flash Frequency (Time Frame - From randomization (Day 1 of Cycle 7), up to 3 years 3 months): 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.
2. Second Progression-free Survival (PFS2) (Time Frame - From randomization (Day 1 of Cycle 7) up to 3 years 3 months): 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.
3. Overall Survival (OS) (Time Frame - From randomization (Day 1 of Cycle 7) up to 3 years 3 months): Overall survival time is defined as the duration from the date of randomization to the date of death from any cause.
4. Prostate Cancer-specific Survival (Time Frame - From randomization (Day 1 Cycle 7) up to 3 years 3 months): Prostate cancer-specific survival is defined as the duration from the date of randomization to the date of death from any cause.
5. Serum Prostate Specific Antigen (PSA) Evaluations (Time Frame - From randomization (Day 1 of Cycle 7) up to 3 years 3 months): Serum PSA evaluations will be measured according to Prostate Cancer Working Group 3 (PCWG3) criteria.
6. Duration of Time on Androgen-deprivation Therapy (ADT) (Time Frame - From randomization (Day 1 of Cycle 7) up to 3 years 3 months): Duration of time on ADT will be reported for all participants.
7. Time to First ADT Restart (Time Frame - From randomization (Day 1 of Cycle 7) up to 3 years 3 months): Time to first ADT restart will be reported.
8. Duration of Time with Testosterone Level Less than (<) 50 nanograms per millilitre (ng/mL) (Time Frame - From randomization (Day 1 of Cycle 7) up to 3 years 3 months): Duration of time with testosterone level <50 ng/mL will be reported.
9. Time to Recovery of Testosterone >50 nanogram per decilitre (ng/dL) (Time Frame - From randomization (Day 1 of Cycle 7) up to 3 years 3 months): The testosterone recovery, defined as a serum testosterone >50 ng/dL will be analyzed.
10. Time to Recovery of Testosterone Greater Than or Equal (>=) Screening Testosterone Level (Time Frame - From randomization (Day 1 of Cycle 7) up to 3 years 3 months): Time to recovery of testosterone >= screening testosterone level will be reported.
11. Time to Testosterone Recovery to Normal Range (>270 ng/dL) (Time Frame - From randomization (Day 1 of Cycle 7) up to 3 years 3 months): Time to serum testosterone recovery to normal range (>270 ng/dL) will be reported.
12. Time to Metastatic Castration-resistant Prostate Cancer (mCRPC) (Time Frame - From randomization (Day 1 of Cycle 7) up to 3 years 3 months): Time to mCRPC will be reported.
13. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (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)): 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.
14. Number of Participants with Abnormal Clinical Laboratory Parameters (Time Frame - From Cycle 1 Day 1 up to 3 years 9 months): Number of participants with abnormal clinical laboratory parameters (hematology, clinical chemistry) will be reported.
15. Number of Participants with Abnormal Vital Sign Parameters (Time Frame - From Cycle 1 Day 1 up to 3 years 9 months): Number of participants with abnormal vital sign parameters (temperature, pulse/heart rate, respiratory rate, and blood pressure) will be reported.
16. Number of Participants with Abnormal Physical Examination Parameters (Time Frame - From Cycle 1 Day 1 up to 3 years 9 months): Number of Participants with Abnormal physical examination parameters will be reported.
17. Hot Flash Related Daily Interference Score (HFRDIS) (Time Frame - Up to 3 years 9 months): 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.
18. Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score (Time Frame - Baseline up to 3 years 9 months): 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.
19. Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire -Prostate Cancer Module (EORTC-PR25) Questionnaire (Time Frame - Baseline up to 3 years 9 months): 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.
20. Change From Baseline in European Organization for the Research and Treatment of Cancer (EORTC) Customized Study Form (Time Frame - Baseline up to 3 years 9 months): 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.
21. Change From Baseline in Patient-Reported Outcomes Measurement Information System Cognitive Function (PROMIS-Cog) Questionnaire (Time Frame - Baseline up to 3 years 9 months): 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.
22. Change From Baseline in Memorial Anxiety Scale for Prostate Cancer (MAX-PC) Questionnaire (Time Frame - Baseline up to 3 years 9 months): 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.
23. Change From Baseline in Patient Health Questionnaire (PHQ-9) Questionnaire (Time Frame - Baseline up to 3 years 9 months): 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.
24. Change From Baseline in Patient Global Impression of Severity scale (PGIS) Questionnaire (Time Frame - Baseline up to 3 years 9 months): 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.
25. Change From Baseline in Patient Global Impression of Change (PGIC) Questionnaire (Time Frame - Baseline up to 3 years 9 months): 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.
26. Time to Recovery From Baseline as Assessed by EORTC-QLQ-C30 (Time Frame - Baseline up to 3 years 9 months): 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.
27. Time to Recovery From Baseline as Assessed by EORTC-PR25 (Time Frame - Baseline up to 3 years 9 months): 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.
28. Time to Recovery From Baseline as Assessed by EORTC Customized Study Form (Time Frame - Baseline up to 3 years 9 months): 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.
29. Time to Recovery From Baseline as Assessed by MAX-PC (Time Frame - Baseline up to 3 years 9 months): 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.
30. Time to Recovery From Baseline as Assessed by PHQ-9 (Time Frame - Baseline up to 3 years 9 months): 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.
31. Time to Recovery From Baseline as Assessed by PGIS (Time Frame - Baseline up to 3 years 9 months): 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.
32. Time to Recovery From Baseline as Assessed by PGIC (Time Frame - Baseline up to 3 years and 9 months): 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.
33. Time to Recovery From Baseline as Assessed by PROMIS-Cog (Time Frame - Baseline up to 3 years 9 months): 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.
34. Time to Deterioration in EORTC-QLQ-C30 Over Time (Time Frame - Up to 3 years 9 months): 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.
35. Time to Deterioration in EORTC-PR25 Over Time (Time Frame - Up to 3 years 9 months): 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.
36. Time to Deterioration in EORTC Customized Study Form Over Time (Time Frame - Up to 3 years 9 months): 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.
37. Time to Deterioration as per PROMIS-Cog Questionnaire Over Time (Time Frame - Up to 3 years 9 months): 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.
38. Time to Deterioration in MAX-PC Questionnaire Over Time (Time Frame - Up to 3 years 9 months): 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.
39. Time to Deterioration as per PHQ-9 Questionnaire Over Time (Time Frame - Up to 3 years 9 months): 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.
40. Time to Deterioration in PGIS Questionnaire Over Time (Time Frame - Up to 3 years 9 months): 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.
41. Time to Deterioration as per PGIC Questionnaire Over Time (Time Frame - Up to 3 years 9 months): 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.
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.
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.
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.
Quelle: ClinicalTrials.gov
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"A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC"
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