A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer
NCT ID: NCT04557059
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
694 participants
INTERVENTIONAL
2020-11-12
2029-08-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Interventional Cohort (Group 1): RT+ LHRHa
Participants will receive radiotherapy (RT) which is defined as prostate-bed plus pelvic lymph node salvage external-beam radiotherapy with or without optional stereotactic body radiation therapy (SBRT), along with a luteinizing hormone-releasing hormone agonist (LHRHa) as a 3-monthly depot preparation within 3 days after randomization and the end of Week 12, or as a 6-monthly depot preparation within 3 days after randomization.
Radiotherapy
Participants will receive radiotherapy (RT) with or without optional stereotactic body radiation therapy (SBRT), which will start within 4 weeks after randomization.
LHRHa
Participants will be administered with LHRHa (example, leuprolide, goserelin, triptorelin acetate) as a 3-monthly depot preparation within 3 days after randomization and the end of Week 12 or as a 6-monthly depot preparation within 3 days after randomization.
Interventional Cohort (Group 2): RT+LHRHa + Apalutamide
Participants will receive prostate-bed plus pelvic lymph node salvage external-beam radiotherapy (RT) with or without optional stereotactic body radiation therapy (SBRT), along with a LHRHa as a 3-monthly depot preparation within 3 days after randomization and the end of Week 12, or as a 6-monthly depot preparation within 3 days after randomization. Participants will also receive 240 milligram (mg) of apalutamide starting within 3 days after randomization as film-coated tablets, to be swallowed whole and together once daily with or without food, for a period of 180 Days.
Radiotherapy
Participants will receive radiotherapy (RT) with or without optional stereotactic body radiation therapy (SBRT), which will start within 4 weeks after randomization.
LHRHa
Participants will be administered with LHRHa (example, leuprolide, goserelin, triptorelin acetate) as a 3-monthly depot preparation within 3 days after randomization and the end of Week 12 or as a 6-monthly depot preparation within 3 days after randomization.
Apalutamide
Participants will receive therapeutic dose of apalutamide 240 mg once daily for 180 Days.
Observational Cohort(Group3) PSMA-PET Negative Participants
Enrollment into this cohort will be stopped further. Participants who were PSMA-PET-negative at screening and were already enrolled in the Observational Cohort will continue in this cohort. Data collected in the course of routine clinical practice during this period will include clinical evaluations, disease progression, therapies administered as per standard-of-care at the study-sites and survival status. For Observational Cohort, information will be entered into the electronic case report form (eCRF) from the medical records at least twice a year. The use of any medicinal product(s) for the treatment and management of participants will be at discretion of the treating physician.
No interventions assigned to this group
Interventions
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Radiotherapy
Participants will receive radiotherapy (RT) with or without optional stereotactic body radiation therapy (SBRT), which will start within 4 weeks after randomization.
LHRHa
Participants will be administered with LHRHa (example, leuprolide, goserelin, triptorelin acetate) as a 3-monthly depot preparation within 3 days after randomization and the end of Week 12 or as a 6-monthly depot preparation within 3 days after randomization.
Apalutamide
Participants will receive therapeutic dose of apalutamide 240 mg once daily for 180 Days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Previously treated with radical prostatectomy with or without lymph node dissection and either: a) for biochemical recurrence after radical prostatectomy (RP): any post-operative prostate-specific antigen (PSA) measurement of less than (\<) 0.1 nanogram/milliliter (ng/mL) within 12 months after RP and without any PSA greater than and equal to (\>=) 0.1 ng/mL within the 4 to 8-week period after RP or b) for persistent PSA after RP: PSA \>=0.1 ng/mL within the 4 to 8-week period after RP, confirmed by additional measurement at least 3 weeks later
* Be able to swallow whole the study drug tablets or follow the instructions for admixing with apple sauce
* Results of the Prostate specific membrane antigen-positron emission tomography (PSMA-PET) at screening as determined by blinded independent, central review (BICR), must be: PSMA-PET-negative for any prostate cancer lesions (that is, no loco-regional lesion and no distant lesions); or PSMA-PET-positive for at least one loco-regional (pelvic) lesion without distant extra-pelvic lesion; or PSMA PET- positive for at least one loco--regional (pelvic) lesion with extra-pelvic lesion(s).
* High risk of developing metastasis defined as; a) for biochemical recurrence after RP: pathological Gleason score greater than or equal to (\>=) 8 evaluated from prostate tissue specimen at radical prostatectomy, or prostate-specific antigen doubling time (PSADT) less than or equal to (\<=) 12 months at the time of screening; b) for persistent PSA after RP: pathological Gleason score \>=8, evaluated from prostate tissue specimen at radical prostatectomy
* Participants with evidence of distant metastasis on screening PSMA-PET scan must have no evidence of prostate cancer metastases on screening CT/MRI of the chest/abdomen/pelvis, Technetium 99m \[99mTc\] whole-body bone scan. Participants with a single bone lesion on 99mTc whole-body bone scan should have confirmatory imaging by CT or MRI; if the confirmatory scan confirms the bone lesion, the participant should be excluded from the study. Conventional images (99mTc-bone scan and CT/MRI) from the screening will be evaluated locally before randomization
* Eastern Cooperative Oncology Group Performance Status Grade 0 or 1
Exclusion Criteria
* Previous treatment with androgen deprivation therapy (ADT) for prostate cancer
* Previously treated for biochemical recurrence (BCR) or persistent PSA after RP (previous surgical treatment of one or more loco-regional lesions is allowed)
* Prior treatment with a CYP17 inhibitor (example, oral ketoconazole, orteronel, abiraterone acetate, galeterone) or any androgen receptor (AR) antagonist including bicalutamide, flutamide, nilutamide, apalutamide, enzalutamide or darolutamide and any other medications that may lower androgen levels (estrogens, progestins, aminoglutethimide, etc.), including bilateral orchiectomy
* Known or suspected contraindications or hypersensitivity to apalutamide, Luteinizing Hormone-Releasing Hormone (LHRH) agonist or any of the components of the formulations
* Prior chemotherapy for prostate cancer
* Any evidence of prostate cancer metastasis on computed tomography/magnetic resonance imaging (CT/MRI) of the chest/abdomen/pelvis or 99mTc whole-body bone scan, at any time prior to screening
18 Years
MALE
No
Sponsors
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Janssen Pharmaceutica N.V., Belgium
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Pharmaceutica N.V., Belgium Clinical Trial
Role: STUDY_DIRECTOR
Janssen Pharmaceutica N.V., Belgium
Locations
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Arizona Urology Specialists
Tucson, Arizona, United States
Arkansas Urology
Little Rock, Arkansas, United States
Colorado Clinical Research
Lakewood, Colorado, United States
Urological Research Network
Hialeah, Florida, United States
First Urology, PSC
Jeffersonville, Indiana, United States
Michigan Institute of Urology
Troy, Michigan, United States
Associated Medical Professionals of Ny
Syracuse, New York, United States
The Urology Group
Cincinnati, Ohio, United States
Oregon Urology Institute
Springfield, Oregon, United States
MidLantic Urology
Bala-Cynwyd, Pennsylvania, United States
Urology Austin
Austin, Texas, United States
Houston Metro Urology
Houston, Texas, United States
Spokane Urology
Spokane, Washington, United States
Bundaberg Hospital
Bundaberg, , Australia
Hervey Bay Hospital
Bundaberg, , Australia
Epworth Healthcare
East Melbourne, , Australia
St Vincent's Hospital - Melbourne
Fitzroy, , Australia
Genesis Care Hurstville
Hurstville, , Australia
Macquarie University Hospital
North Ryde, , Australia
Calvary Mater Newcastle
Waratah, , Australia
GenesisCare Wembley
Wembley, , Australia
Ordensklinikum Linz GmbH Elisabethinen
Linz, , Austria
Universitaetsklinikum Salzburg Landeskrankenhaus
Salzburg, , Austria
Medizinische Universitaet Wien
Vienna, , Austria
ZAS Augustinus
Antwerp, , Belgium
A.Z. Sint Jan
Bruges, , Belgium
UZ Gent
Ghent, , Belgium
Az Groeninge
Kortrijk, , Belgium
Empresa Brasileira de Servicos Hospitalares - EBSERH - Hospital das Clinicas da UFMG
Belo Horizonte, , Brazil
Liga Paranaense de Combate ao Cancer
Curitiba, , Brazil
Liga Norte Riograndense Contra O Cancer
Natal, , Brazil
Associacao Hospitalar Moinhos de Vento
Porto Alegre, , Brazil
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, , Brazil
Oncoclinicas Rio de Janeiro S A
Rio de Janeiro, , Brazil
Hospital Sao Rafael
Salvador, , Brazil
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
São Paulo, , Brazil
Hospital Alemao Oswaldo Cruz
São Paulo, , Brazil
Hospital Sao Camilo Unidade Vila Mariana
São Paulo, , Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, , Brazil
Fakultni nemocnice Plzen, Urologicka klinika
Pilsen, , Czechia
Urocentrum Praha
Prague, , Czechia
Urologicka klinika 1 LF UK a VFN
Prague, , Czechia
Fakultni nemocnice v Motole
Prague, , Czechia
Aalborg University Hospital
Aalborg, , Denmark
Aarhus University Hospital
Aarhus N, , Denmark
Rigshospitalet
Copenhagen N, , Denmark
Gentofte Herlev Hospital
Herlev, , Denmark
Helsinki University Hospital
Helsinki, , Finland
Oulu University Hospital
Oulu, , Finland
Tampere University Hospital
Tampere, , Finland
Turku University Hospital
Turku, , Finland
Vaasa Central Hospital
Vaasa, , Finland
Vivantes Klinikum Am Urban
Berlin, , Germany
Städtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer
Braunschweig, , Germany
Universitatsklinikum Carl Gustav Carcus Dresden
Dresden, , Germany
Universitatsklinikum Essen
Essen, , Germany
Klinikum rechts der Isar - der Technischen Universität München
München, , Germany
Universitaetsklinikum Muenster
Münster, , Germany
Péterfy Sándor utcai Kórház
Budapest, , Hungary
Budapesti Bajcsy Zsilinszky Korhaz es Rendelointezet
Budapest, , Hungary
Orszagos Onkologiai Intezet
Budapest, , Hungary
Eszak Budai Szent Janos Centrumkorhaz
Budapest, , Hungary
Budapesti Uzsoki Utcai Korhaz
Budapest, , Hungary
Jahn Ferenc Del-pesti Korhaz es Rendelointezet
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
Radioterapia Oncologica, A.O.U. San'T Orsola
Bologna, , Italy
Azienda Ospedaliero Universitaria Careggi
Florence, , Italy
Ospedale San Raffaele
Milan, , Italy
Fondazione Policlinico Tor Vergata
Roma, , Italy
Istituto Nazionale Tumori Regina Elena
Roma, , Italy
Azienda Ospedaliera Sant Andrea
Roma, , Italy
King Hussein Cancer Center
Amman, , Jordan
St Georges Hospital university medical centre
Beirut, , Lebanon
American Universitty of Beirut Medical Center
Beirut, , Lebanon
Notre Dame De Secours
Byblos, , Lebanon
Centre Hospitalier du Nord
Zghartā, , Lebanon
Consultorio de Especialidad en Urologia Privado
Durango, , Mexico
Hospital MAC Leon
León, , Mexico
Avix Investigacion Clinica S C
Monterrey, , Mexico
Oncologia Integral Satelite
Naucalpan, , Mexico
Centro de Investigacion Clinica de Oaxaca
Oaxaca City, , Mexico
Oncocenter
Puebla City, , Mexico
Cuidados Oncologicos
Querétaro, , Mexico
Centrum Onkologii im Prof F Lukaszczyka w Bydgoszczy
Bydgoszcz, , Poland
NU-MED Grupa S.A Centrum Radioterapii i Onkologii
Elblag, , Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Szpitale Pomorskie Sp z o o
Gdynia, , Poland
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
Kielce, , Poland
Szpital Wojewodzki im Mikolaja Kopernika w Koszalinie
Koszalin, , Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi
Lodz, , Poland
Radomskie Centrum Onkologii
Radom, , Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Warsaw, , Poland
Ipo Lisboa
Lisbon, , Portugal
Hosp. Cuf Tejo
Lisbon, , Portugal
Fund. Champalimaud
Lisbon, , Portugal
Uls Lisboa Ocidental - Hosp. Sao Francisco Xavier
Lisbon, , Portugal
Hosp. Da Luz Lisboa
Lisbon, , Portugal
Uls Santa Maria - Hosp. Santa Maria
Lisbon, , Portugal
Uls Santo Antonio - Hosp. Santo Antonio
Porto, , Portugal
Uls de Entre Douro E Vouga - Hosp. Sao Sebastiao
Santa Maria da Feira, , Portugal
Ivanovo Regional Oncology Dispensary
Ivanovo, , Russia
City Clinical Hospital #57
Moscow, , Russia
I.M. Sechenov First Moscow State Medical University
Moscow, , Russia
Hertzen Oncology Research Institute
Moscow, , Russia
Leningrad Regional Oncology Dispensary
Saint Petersburg, , Russia
SPb SBIH 'City Clinical Oncological Dispensary'
Saint Petersburg, , Russia
Multifunctional clinical medical center 'Medical city'
Tyumen, , Russia
SHI Sverdlovsk Regional Clinical Hospital #1
Yekaterinburg, , Russia
CUIMED - urologická ambulancia
Bratislava, , Slovakia
Východoslovenský Onkologický Ústav
Košice, , Slovakia
Univerzitná nemocnica Martin
Martin, , Slovakia
Uroexam s.r.o.
Nitra, , Slovakia
Urologicka ambulancia e.cho Poprad, s.r.o
Poprad, , Slovakia
MILAB s.r.o.
Prešov, , Slovakia
Privátna urologická ambulancia
Trenčín, , Slovakia
Hospital Universitario Puerto Del Mar
Cadiz, , Spain
Hosp. Arquitecto Marcide
Ferrol, , Spain
Hosp. de Jerez de La Frontera
Jerez de la Frontera, , Spain
Hosp. Univ. 12 de Octubre
Madrid, , Spain
Hosp. Univ. de La Paz
Madrid, , Spain
Hosp Virgen de La Victoria
Málaga, , Spain
Clinica Univ. de Navarra
Pamplona, , Spain
Hosp. de Navarra
Pamplona, , Spain
Hosp. Virgen Del Rocio
Seville, , Spain
Hosp. Univ. I Politecni La Fe
Valencia, , Spain
Hosp. Clinico Univ. Lozano Blesa
Zaragoza, , Spain
Urologiska Mottagningen
Malmo, , Sweden
Prostatacancercentrum
Stockholm, , Sweden
Sodersjukhuset
Stockholm, , Sweden
Adana Baskent Yuregir Hospital
Adana, , Turkey (Türkiye)
Hacettepe University Medical Faculty
Ankara, , Turkey (Türkiye)
Memorial Ankara Hastanesi
Ankara, , Turkey (Türkiye)
Ankara University Medical Faculty
Ankara, , Turkey (Türkiye)
Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara, , Turkey (Türkiye)
Koc University, School of Medicine, Koc University Hospital
Istanbul, , Turkey (Türkiye)
Istanbul University Cerrahpasa Medical Faculty
Istanbul, , Turkey (Türkiye)
Bakirkoy Training and Research Hospital
Istanbul, , Turkey (Türkiye)
Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
Istanbul, , Turkey (Türkiye)
Kartal Dr Lutfi Kirdar Egitim ve Arastirma Hastanesi
Istanbul, , Turkey (Türkiye)
Dokuz Eylul Universitesi Tip Fakultesi
Izmir, , Turkey (Türkiye)
Sakarya Üniversitesi Tıp Fakültesi Hastanesi
Sakarya, , Turkey (Türkiye)
Countries
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Other Identifiers
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56021927PCR3015
Identifier Type: OTHER
Identifier Source: secondary_id
2019-002957-46
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-505852-23-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CR108705
Identifier Type: -
Identifier Source: org_study_id
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