Clinical trial NCT05884398: A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC
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
Overall status: RECRUITING
Phase: PHASE3
Conditions: Metastatic Castrate-sensitive Prostate Cancer
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2023-06-01
Enrollment: 420
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of prostate cancer prior to screening with histologically or cytologically confirmed adenocarcinoma of the prostate
* For participants not undergoing Gender-affirming care: Metastatic prostate cancer disease documented by conventional imaging (example, computed tomography \[CT\], magnetic resonance imaging \[MRI\], or bone scan) and/or next-generation imaging \[NGI\] demonstrating greater than equal (\>=) 2 distinct extraprostatic sites of metastasis
* For participants undergoing Gender-affirming care: No evidence of metastasis by either conventional imaging (example, CT, MRI, or bone scan) and/or NGI is also acceptable
* For participants not undergoing gender-affirming care: testosterone levels \> 50 (ng/dL) nanograms per deciliter at screening, except for those who may have received ADT prior to screening. Participants are allowed to have received up to 3 months of (ADT) androgen-deprivation therapy prior to enrollment
* For participants undergoing Gender-affirming care: There is no testosterone level requirement for inclusion
* Have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. Participants with ECOG PS 2 or 3 are eligible for the study if the ECOG PS score is related to stable physical limitations (example, wheelchair-bound due to prior spinal cord injury) and not related to prostate cancer or associated therapy
* A participant must agree not to plan to conceive a child while enrolled in this study or within 3 months after the last dose of study treatment
* Must be able to take whole apalutamide tablets by swallowing alone or with another vehicle (example, applesauce)
* Assigned male at birth, inclusive of all gender identities

Exclusion Criteria:

* History of seizure or known condition that has been determined to significantly predispose to seizure per investigator
* Pelvic lymph nodes as only site of metastasis
* Known allergies, hypersensitivity, or intolerance to excipients of apalutamide
* Any of the following within 6 months prior to screening: severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, uncontrolled hypertension, clinically significant arterial or venous thromboembolic events
* Gastrointestinal disorder affecting absorption
* Participants who have undergone a bilateral orchiectomy with the exception of participants who completed this as part of their gender-affirming care or a result of a variation in physical sex development

Primary outcomes:
measure: Percentage of Participants With 18-Months Radiographic Progression-free Survival (rPFS)
timeFrame: From randomization (Day 1 of Cycle 7) up to 18 months
measure: Percent Change From Randomization in Severity of Adjusted Hot Flash Score at 18 Months
timeFrame: From randomization (Day 1 of Cycle 7) up to 18 months
Secondary outcomes:
measure: Mean Percentage Changes From Randomization in Severity Adjusted Hot Flash Score and Hot Flash Frequency
timeFrame: From randomization (Day 1 of Cycle 7), up to 3 years 3 months
measure: Second Progression-free Survival (PFS2)
timeFrame: From randomization (Day 1 of Cycle 7) up to 3 years 3 months
measure: Overall Survival (OS)
timeFrame: From randomization (Day 1 of Cycle 7) up to 3 years 3 months
measure: Prostate Cancer-specific Survival
timeFrame: From randomization (Day 1 Cycle 7) up to 3 years 3 months
measure: Serum Prostate Specific Antigen (PSA) Evaluations
timeFrame: From randomization (Day 1 of Cycle 7) up to 3 years 3 months
measure: Duration of Time on Androgen-deprivation Therapy (ADT)
timeFrame: From randomization (Day 1 of Cycle 7) up to 3 years 3 months
measure: Time to First ADT Restart
timeFrame: From randomization (Day 1 of Cycle 7) up to 3 years 3 months
measure: Duration of Time with Testosterone Level Less than (<) 50 nanograms per millilitre (ng/mL)
timeFrame: From randomization (Day 1 of Cycle 7) up to 3 years 3 months
measure: Time to Recovery of Testosterone >50 nanogram per decilitre (ng/dL)
timeFrame: From randomization (Day 1 of Cycle 7) up to 3 years 3 months
measure: Time to Recovery of Testosterone Greater Than or Equal (>=) Screening Testosterone Level
timeFrame: From randomization (Day 1 of Cycle 7) up to 3 years 3 months
measure: Time to Testosterone Recovery to Normal Range (>270 ng/dL)
timeFrame: From randomization (Day 1 of Cycle 7) up to 3 years 3 months
measure: Time to Metastatic Castration-resistant Prostate Cancer (mCRPC)
timeFrame: From randomization (Day 1 of Cycle 7) up to 3 years 3 months
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: 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)
measure: Number of Participants with Abnormal Clinical Laboratory Parameters
timeFrame: From Cycle 1 Day 1 up to 3 years 9 months
measure: Number of Participants with Abnormal Vital Sign Parameters
timeFrame: From Cycle 1 Day 1 up to 3 years 9 months
measure: Number of Participants with Abnormal Physical Examination Parameters
timeFrame: From Cycle 1 Day 1 up to 3 years 9 months
measure: Hot Flash Related Daily Interference Score (HFRDIS)
timeFrame: Up to 3 years 9 months
measure: Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score
timeFrame: Baseline up to 3 years 9 months
measure: Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire -Prostate Cancer Module (EORTC-PR25) Questionnaire
timeFrame: Baseline up to 3 years 9 months
measure: Change From Baseline in European Organization for the Research and Treatment of Cancer (EORTC) Customized Study Form
timeFrame: Baseline up to 3 years 9 months
measure: Change From Baseline in Patient-Reported Outcomes Measurement Information System Cognitive Function (PROMIS-Cog) Questionnaire
timeFrame: Baseline up to 3 years 9 months
measure: Change From Baseline in Memorial Anxiety Scale for Prostate Cancer (MAX-PC) Questionnaire
timeFrame: Baseline up to 3 years 9 months
measure: Change From Baseline in Patient Health Questionnaire (PHQ-9) Questionnaire
timeFrame: Baseline up to 3 years 9 months
measure: Change From Baseline in Patient Global Impression of Severity scale (PGIS) Questionnaire
timeFrame: Baseline up to 3 years 9 months
measure: Change From Baseline in Patient Global Impression of Change (PGIC) Questionnaire
timeFrame: Baseline up to 3 years 9 months
measure: Time to Recovery From Baseline as Assessed by EORTC-QLQ-C30
timeFrame: Baseline up to 3 years 9 months
measure: Time to Recovery From Baseline as Assessed by EORTC-PR25
timeFrame: Baseline up to 3 years 9 months
measure: Time to Recovery From Baseline as Assessed by EORTC Customized Study Form
timeFrame: Baseline up to 3 years 9 months
measure: Time to Recovery From Baseline as Assessed by MAX-PC
timeFrame: Baseline up to 3 years 9 months
measure: Time to Recovery From Baseline as Assessed by PHQ-9
timeFrame: Baseline up to 3 years 9 months
measure: Time to Recovery From Baseline as Assessed by PGIS
timeFrame: Baseline up to 3 years 9 months
measure: Time to Recovery From Baseline as Assessed by PGIC
timeFrame: Baseline up to 3 years and 9 months
measure: Time to Recovery From Baseline as Assessed by PROMIS-Cog
timeFrame: Baseline up to 3 years 9 months
measure: Time to Deterioration in EORTC-QLQ-C30 Over Time
timeFrame: Up to 3 years 9 months
measure: Time to Deterioration in EORTC-PR25 Over Time
timeFrame: Up to 3 years 9 months
measure: Time to Deterioration in EORTC Customized Study Form Over Time
timeFrame: Up to 3 years 9 months
measure: Time to Deterioration as per PROMIS-Cog Questionnaire Over Time
timeFrame: Up to 3 years 9 months
measure: Time to Deterioration in MAX-PC Questionnaire Over Time
timeFrame: Up to 3 years 9 months
measure: Time to Deterioration as per PHQ-9 Questionnaire Over Time
timeFrame: Up to 3 years 9 months
measure: Time to Deterioration in PGIS Questionnaire Over Time
timeFrame: Up to 3 years 9 months
measure: Time to Deterioration as per PGIC Questionnaire Over Time
timeFrame: Up to 3 years 9 months
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Urology Centers Of Alabama
state: Alabama
city: Tucson
country: United States
facility: Arizona Urology Specialists
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Urology
state: Arkansas
city: Fresno
country: United States
facility: Urology Associates of Central California
state: California
city: San Francisco
country: United States
facility: VA Medical Center
state: California
city: Santa Barbara
country: United States
facility: Sansum Clinic Pharm
state: California
city: Lakewood
country: United States
facility: Colorado Clinical Research
state: Colorado
city: Daytona Beach
country: United States
facility: Advanced Urology Institute
state: Florida
city: Chicago Ridge
country: United States
facility: Associated Urological Specialists LLC
state: Illinois
city: Joliet
country: United States
facility: Advanced Urology Associates
state: Illinois
city: Greenwood
country: United States
facility: Urology of Indiana
state: Indiana
city: Jeffersonville
country: United States
facility: First Urology, PSC
state: Indiana
city: Silver Spring
country: United States
facility: Maryland Oncology Hematology P A
state: Maryland
city: Towson
country: United States
facility: Chesapeake Urology Research Associates
state: Maryland
city: Troy
country: United States
facility: Michigan Institute of Urology
state: Michigan
city: Basking Ridge
country: United States
facility: MSKCC Basking Ridge
state: New Jersey
city: Middletown
country: United States
facility: MSKCC Monmouth
state: New Jersey
city: Montvale
country: United States
facility: MSKCC Bergen
state: New Jersey
city: Commack
country: United States
facility: MSKCC Commack
state: New York
city: Harrison
country: United States
facility: MSKCC Westchester
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Syracuse
country: United States
facility: Associated Medical Professionals
state: New York
city: Uniondale
country: United States
facility: MSKCC Nassau Regional Cancer Center
state: New York
city: Cincinnati
country: United States
facility: TriState Urologic Services PSC Inc. DBA The Urology Group
state: Ohio
city: Gahanna
country: United States
facility: Central Ohio Urology Group
state: Ohio
city: Middleburg Heights
country: United States
facility: Helios Clinical Research, LLC
state: Ohio
city: Tigard
country: United States
facility: Northwest Cancer Specialists PC
state: Oregon
city: Bala-Cynwyd
country: United States
facility: Centers for Advanced Urology LLC d b a MidLantic Urology
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: VA Pittsburgh
state: Pennsylvania
city: Germantown
country: United States
facility: The Conrad Pearson Clinic
state: Tennessee
city: Nashville
country: United States
facility: Urology Associates
state: Tennessee
city: Austin
country: United States
facility: Texas Oncology P A
state: Texas
city: Dallas
country: United States
facility: Parkland Health and Hospital System
state: Texas
city: Dallas
country: United States
facility: Texas Oncology P A
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Texas Oncology P A
state: Texas
city: Houston
country: United States
facility: Houston Metro Urology
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology San Antonio Northeast
state: Texas
city: Wichita Falls
country: United States
facility: Texas Oncology P A
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Huntsman Cancer Institute
state: Utah
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Roanoke
country: United States
facility: Oncology and Hematology Associates of Southwest Virginia, Inc.
state: Virginia
city: Virginia Beach
country: United States
facility: Urology Of Virginia, Pllc
state: Virginia
city: Macquarie University
country: Australia
facility: Macquarie University Hospital
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
city: South Brisbane
country: Australia
facility: Mater Misericordiae Hospital
city: Barretos
country: Brazil
facility: Fundacao Pio XII
city: Belo Horizonte
country: Brazil
facility: Hospital das Clínicas - Universidade Federal de Minas Gerais
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra O Cancer
city: Rio de Janeiro
country: Brazil
facility: Ministerio da Saude Instituto Nacional do Cancer
city: Salvador
country: Brazil
facility: Instituto D Or de Pesquisa e Ensino
city: Santo André
country: Brazil
facility: CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia
city: Sao Paulo
country: Brazil
facility: Fundacao Faculdade de Medicina Instituto do Cancer do Estado de Sao Paulo
city: Calgary
country: Canada
facility: Southern Alberta Institute of Urology / Prostate Cancer Centre
state: Alberta
city: Halifax
country: Canada
facility: Nova Scotia Health Authority
state: Nova Scotia
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Center
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Quebec
country: Canada
facility: CHU de Quebec Universite Laval Hopital de l Enfant Jesus
city: Beijing
country: China
facility: Peking University First Hospital
city: Changchun
country: China
facility: The First Hospital of Jilin University
city: Chengdu
country: China
facility: West China School of Medicine/West China Hospital, Sichuan University
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical Hospital
city: Jinan
country: China
facility: Shandong Provincial Hospital
city: Ningbo
country: China
facility: Ningbo First Hospital
city: Shenyang
country: China
facility: Shengjing Hospital Of China Medical University
city: Wuhan
country: China
facility: TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology
city: XI An
country: China
facility: The First Affiliated Hospital of Xian Jiaotong University
city: Bordeaux
country: France
facility: Institut Bergonie
city: Lyon
country: France
facility: Centre Leon Berard
city: Paris
country: France
facility: Hopital Cochin
city: Rennes
country: France
facility: Chu Rennes Hopital Pontchaillou
city: Villejuif Cedex
country: France
facility: Gustave Roussy
city: Aachen
country: Germany
facility: Universitaetsklinikum der RWTH Aachen
city: Augsburg
country: Germany
facility: Klinikum Augsburg
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus TU Dresden
city: Koeln
country: Germany
facility: Universitaetsklinikum Koelnt
city: Lubeck
country: Germany
facility: Universitatsklinikum Schleswig Holstein Campus Lubeck
city: Muenchen
country: Germany
facility: Klinikum rechts der Isar - der Technischen Universität München
city: Nuertingen
country: Germany
facility: Studienpraxis Urologie Nurtingen
city: Würzburg
country: Germany
facility: Universitatsklinikum Wurzburg
city: Chihuahua
country: Mexico
facility: SCIENTIA Investigacion Clinica SC
city: Durango
country: Mexico
facility: Consultorio de Especialidad en Urologia Privado
city: Merida
country: Mexico
facility: Medical Care & Research SA de CV
city: Queretaro
country: Mexico
facility: Cuidados Oncologicos
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im Prof F Lukaszczyka
city: Koszalin
country: Poland
facility: Szpital Wojewodzki im Mikolaja Kopernika w Koszalinie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
city: Warszawa
country: Poland
facility: Szpital Grochowski Im Dr Med Rafala Masztaka Sp Z O O
city: Wroclaw
country: Poland
facility: Polimed Specjalistyczna Przychodnia Lekarska Wieslaw Grazyna Tupikowski Bednarek Tupikowska S C
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: