Trial Title:
A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC
NCT ID:
NCT05884398
Condition:
Metastatic Castrate-sensitive Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Hypersensitivity
Androgens
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Apalutamide
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.
Arm group label:
Arm A (Intermittent ADT Group)
Arm group label:
Arm B (Continuous ADT Group)
Intervention type:
Drug
Intervention name:
Androgen-deprivation Therapy (ADT)
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.
Arm group label:
Arm A (Intermittent ADT Group)
Arm group label:
Arm B (Continuous ADT Group)
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.
Criteria for 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
Gender:
Male
Gender based:
Yes
Gender description:
Male assigned at birth, inclusive of all gender identities.
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Urology Centers Of Alabama
Address:
City:
Homewood
Zip:
35209
Country:
United States
Status:
Recruiting
Facility:
Name:
Arizona Urology Specialists
Address:
City:
Tucson
Zip:
85741
Country:
United States
Status:
Recruiting
Facility:
Name:
Arkansas Urology
Address:
City:
Little Rock
Zip:
72211
Country:
United States
Status:
Recruiting
Facility:
Name:
Urology Associates of Central California
Address:
City:
Fresno
Zip:
93720
Country:
United States
Status:
Recruiting
Facility:
Name:
VA Medical Center
Address:
City:
San Francisco
Zip:
94121
Country:
United States
Status:
Recruiting
Facility:
Name:
Sansum Clinic Pharm
Address:
City:
Santa Barbara
Zip:
93105
Country:
United States
Status:
Recruiting
Facility:
Name:
Colorado Clinical Research
Address:
City:
Lakewood
Zip:
80228
Country:
United States
Status:
Recruiting
Facility:
Name:
Advanced Urology Institute
Address:
City:
Daytona Beach
Zip:
32114
Country:
United States
Status:
Recruiting
Facility:
Name:
Associated Urological Specialists LLC
Address:
City:
Chicago Ridge
Zip:
60415
Country:
United States
Status:
Recruiting
Facility:
Name:
Advanced Urology Associates
Address:
City:
Joliet
Zip:
60431
Country:
United States
Status:
Recruiting
Facility:
Name:
Urology of Indiana
Address:
City:
Greenwood
Zip:
46143
Country:
United States
Status:
Recruiting
Facility:
Name:
First Urology, PSC
Address:
City:
Jeffersonville
Zip:
47130
Country:
United States
Status:
Recruiting
Facility:
Name:
Maryland Oncology Hematology P A
Address:
City:
Silver Spring
Zip:
20904
Country:
United States
Status:
Recruiting
Facility:
Name:
Chesapeake Urology Research Associates
Address:
City:
Towson
Zip:
21204
Country:
United States
Status:
Recruiting
Facility:
Name:
Michigan Institute of Urology
Address:
City:
Troy
Zip:
48084
Country:
United States
Status:
Recruiting
Facility:
Name:
MSKCC Basking Ridge
Address:
City:
Basking Ridge
Zip:
07920
Country:
United States
Status:
Recruiting
Facility:
Name:
MSKCC Monmouth
Address:
City:
Middletown
Zip:
07748
Country:
United States
Status:
Recruiting
Facility:
Name:
MSKCC Bergen
Address:
City:
Montvale
Zip:
07645
Country:
United States
Status:
Recruiting
Facility:
Name:
MSKCC Commack
Address:
City:
Commack
Zip:
11725
Country:
United States
Status:
Recruiting
Facility:
Name:
MSKCC Westchester
Address:
City:
Harrison
Zip:
10604
Country:
United States
Status:
Recruiting
Facility:
Name:
Columbia University Medical Center
Address:
City:
New York
Zip:
10032
Country:
United States
Status:
Recruiting
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Facility:
Name:
Associated Medical Professionals
Address:
City:
Syracuse
Zip:
13210
Country:
United States
Status:
Recruiting
Facility:
Name:
MSKCC Nassau Regional Cancer Center
Address:
City:
Uniondale
Zip:
11553
Country:
United States
Status:
Recruiting
Facility:
Name:
TriState Urologic Services PSC Inc. DBA The Urology Group
Address:
City:
Cincinnati
Zip:
45212
Country:
United States
Status:
Recruiting
Facility:
Name:
Central Ohio Urology Group
Address:
City:
Gahanna
Zip:
43230
Country:
United States
Status:
Recruiting
Facility:
Name:
Helios Clinical Research, LLC
Address:
City:
Middleburg Heights
Zip:
44130
Country:
United States
Status:
Recruiting
Facility:
Name:
Northwest Cancer Specialists PC
Address:
City:
Tigard
Zip:
97223
Country:
United States
Status:
Recruiting
Facility:
Name:
Centers for Advanced Urology LLC d b a MidLantic Urology
Address:
City:
Bala-Cynwyd
Zip:
19004
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Pittsburgh Medical Center
Address:
City:
Pittsburgh
Zip:
15232
Country:
United States
Status:
Recruiting
Facility:
Name:
VA Pittsburgh
Address:
City:
Pittsburgh
Zip:
15240
Country:
United States
Status:
Recruiting
Facility:
Name:
The Conrad Pearson Clinic
Address:
City:
Germantown
Zip:
38138
Country:
United States
Status:
Recruiting
Facility:
Name:
Urology Associates
Address:
City:
Nashville
Zip:
37209
Country:
United States
Status:
Recruiting
Facility:
Name:
Texas Oncology P A
Address:
City:
Austin
Zip:
78731
Country:
United States
Status:
Recruiting
Facility:
Name:
Parkland Health and Hospital System
Address:
City:
Dallas
Zip:
75235
Country:
United States
Status:
Recruiting
Facility:
Name:
Texas Oncology P A
Address:
City:
Dallas
Zip:
75246
Country:
United States
Status:
Recruiting
Facility:
Name:
UT Southwestern Medical Center
Address:
City:
Dallas
Zip:
75390
Country:
United States
Status:
Recruiting
Facility:
Name:
Texas Oncology P A
Address:
City:
Houston
Zip:
77024
Country:
United States
Status:
Recruiting
Facility:
Name:
Houston Metro Urology
Address:
City:
Houston
Zip:
77027
Country:
United States
Status:
Recruiting
Facility:
Name:
Texas Oncology San Antonio Northeast
Address:
City:
San Antonio
Zip:
78217
Country:
United States
Status:
Recruiting
Facility:
Name:
Texas Oncology P A
Address:
City:
Wichita Falls
Zip:
76310
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Utah Huntsman Cancer Institute
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Status:
Recruiting
Facility:
Name:
Virginia Oncology Associates
Address:
City:
Norfolk
Zip:
23502
Country:
United States
Status:
Recruiting
Facility:
Name:
Oncology and Hematology Associates of Southwest Virginia, Inc.
Address:
City:
Roanoke
Zip:
98684
Country:
United States
Status:
Recruiting
Facility:
Name:
Urology Of Virginia, Pllc
Address:
City:
Virginia Beach
Zip:
23462
Country:
United States
Status:
Recruiting
Facility:
Name:
Macquarie University Hospital
Address:
City:
Macquarie University
Zip:
2109
Country:
Australia
Status:
Recruiting
Facility:
Name:
Peter MacCallum Cancer Centre
Address:
City:
Melbourne
Zip:
3000
Country:
Australia
Status:
Recruiting
Facility:
Name:
Mater Misericordiae Hospital
Address:
City:
South Brisbane
Zip:
4101
Country:
Australia
Status:
Recruiting
Facility:
Name:
Fundacao Pio XII
Address:
City:
Barretos
Zip:
14784 400
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Hospital das Clínicas - Universidade Federal de Minas Gerais
Address:
City:
Belo Horizonte
Zip:
30130-100
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Liga Norte Riograndense Contra O Cancer
Address:
City:
Natal
Zip:
59062 000
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Ministerio da Saude Instituto Nacional do Cancer
Address:
City:
Rio de Janeiro
Zip:
20230-130
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Instituto D Or de Pesquisa e Ensino
Address:
City:
Salvador
Zip:
41253 190
Country:
Brazil
Status:
Recruiting
Facility:
Name:
CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia
Address:
City:
Santo André
Zip:
09060-650
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Fundacao Faculdade de Medicina Instituto do Cancer do Estado de Sao Paulo
Address:
City:
São Paulo
Zip:
01246-000
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Southern Alberta Institute of Urology / Prostate Cancer Centre
Address:
City:
Calgary
Zip:
T2V 1P9
Country:
Canada
Status:
Recruiting
Facility:
Name:
Nova Scotia Health Authority
Address:
City:
Halifax
Zip:
B3H 2Y9
Country:
Canada
Status:
Recruiting
Facility:
Name:
Sunnybrook Health Sciences Center
Address:
City:
Toronto
Zip:
M4N 3M5
Country:
Canada
Status:
Recruiting
Facility:
Name:
Princess Margaret Hospital
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Status:
Recruiting
Facility:
Name:
CHU de Quebec Universite Laval Hopital de l Enfant Jesus
Address:
City:
Quebec
Zip:
G1J 1Z4
Country:
Canada
Status:
Recruiting
Facility:
Name:
The First Hospital of Jilin University
Address:
City:
Changchun
Zip:
130021
Country:
China
Status:
Recruiting
Facility:
Name:
West China School of Medicine/West China Hospital, Sichuan University
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Recruiting
Facility:
Name:
Nanfang Hospital of Southern Medical Hospital
Address:
City:
Guangzhou
Zip:
510515
Country:
China
Status:
Recruiting
Facility:
Name:
Shandong Provincial Hospital
Address:
City:
Jinan
Zip:
250021
Country:
China
Status:
Recruiting
Facility:
Name:
Ningbo First Hospital
Address:
City:
Ningbo
Zip:
315010
Country:
China
Status:
Recruiting
Facility:
Name:
Shengjing Hospital Of China Medical University
Address:
City:
Shenyang
Zip:
110004
Country:
China
Status:
Recruiting
Facility:
Name:
TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology
Address:
City:
Wuhan
Zip:
430030
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hospital of Xian Jiaotong University
Address:
City:
XI An
Zip:
710061
Country:
China
Status:
Recruiting
Facility:
Name:
Institut Bergonie
Address:
City:
Bordeaux
Zip:
33076
Country:
France
Status:
Recruiting
Facility:
Name:
Centre Leon Berard
Address:
City:
Lyon
Zip:
69373
Country:
France
Status:
Recruiting
Facility:
Name:
Hopital Cochin
Address:
City:
Paris
Zip:
75014
Country:
France
Status:
Recruiting
Facility:
Name:
Chu Rennes Hopital Pontchaillou
Address:
City:
Rennes
Zip:
35000
Country:
France
Status:
Recruiting
Facility:
Name:
Gustave Roussy
Address:
City:
Villejuif Cedex
Zip:
94805
Country:
France
Status:
Recruiting
Facility:
Name:
Universitaetsklinikum der RWTH Aachen
Address:
City:
Aachen
Zip:
52074
Country:
Germany
Status:
Recruiting
Facility:
Name:
Klinikum Augsburg
Address:
City:
Augsburg
Zip:
D-86158
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitaetsklinikum Carl Gustav Carus TU Dresden
Address:
City:
Dresden
Zip:
01307
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitaetsklinikum Koelnt
Address:
City:
Koeln
Zip:
50937
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitatsklinikum Schleswig Holstein Campus Lubeck
Address:
City:
Lubeck
Zip:
23538
Country:
Germany
Status:
Recruiting
Facility:
Name:
Klinikum rechts der Isar - der Technischen Universität München
Address:
City:
Muenchen
Zip:
81675
Country:
Germany
Status:
Recruiting
Facility:
Name:
Studienpraxis Urologie Nurtingen
Address:
City:
Nuertingen
Zip:
72622
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitatsklinikum Wurzburg
Address:
City:
Würzburg
Zip:
97080
Country:
Germany
Status:
Recruiting
Facility:
Name:
SCIENTIA Investigacion Clinica SC
Address:
City:
Chihuahua
Zip:
31207
Country:
Mexico
Status:
Recruiting
Facility:
Name:
Consultorio de Especialidad en Urologia Privado
Address:
City:
Durango
Zip:
34000
Country:
Mexico
Status:
Recruiting
Facility:
Name:
Medical Care & Research SA de CV
Address:
City:
Merida
Zip:
97070
Country:
Mexico
Status:
Recruiting
Facility:
Name:
Cuidados Oncologicos
Address:
City:
Queretaro
Zip:
76000
Country:
Mexico
Status:
Recruiting
Facility:
Name:
Centrum Onkologii im. Prof. F. Lukaszczyka
Address:
City:
Bydgoszcz
Zip:
85-796
Country:
Poland
Status:
Recruiting
Facility:
Name:
Szpital Wojewodzki im Mikolaja Kopernika w Koszalinie
Address:
City:
Koszalin
Zip:
75-581
Country:
Poland
Status:
Recruiting
Facility:
Name:
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Address:
City:
Warszawa
Zip:
02 781
Country:
Poland
Status:
Recruiting
Facility:
Name:
Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o.
Address:
City:
Warszawa
Zip:
04-073
Country:
Poland
Status:
Recruiting
Facility:
Name:
Specjalistyczna przychodnia lekarska POLIMED
Address:
City:
Wroclaw
Zip:
53-329
Country:
Poland
Status:
Recruiting
Start date:
August 31, 2023
Completion date:
January 7, 2027
Lead sponsor:
Agency:
Janssen Research & Development, LLC
Agency class:
Industry
Source:
Janssen Research & Development, LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05884398
