A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer (PRIMORDIUM)

A Randomized, Controlled, Multicenter, Open-label Study to Investigate the Efficacy and Safety of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer, Assessed by PSMA-PET With an Observational Cohort

The main purpose of this study is to determine if the addition of apalutamide to radiotherapy (RT) plus luteinizing hormone-releasing hormone agonist (LHRHa) delays metastatic progression as assessed by prostate specific membrane antigen-positron emission tomography (PSMA-PET) or death compared with RT plus LHRHa alone.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostatic Neoplasms
• Intervention / Treatment: Radiation: Radiotherapy; Drug: LHRHa; Drug: Apalutamide

Detailed Description

Prostate cancer is currently the fifth leading cause of cancer deaths among men globally, with 1 million diagnosed per year and mortality burden of over 300,000 deaths. The hypothesis of study is addition of apalutamide to RT+ LHRHa provides superior efficacy in terms of PSMA-PET metastatic progression-free survival-ppMPFS. Apalutamide is a non-steroidal androgen receptor (AR) antagonist being developed for the treatment of prostate cancer. RT+LHRHa is a combination therapy, when administered concomitantly, in high-risk patients with BCR relapsing after RP, potentially leads to relevant delay in the metastatic progression of prostate cancer at an early stage of the disease, or even cure in some cases. Study consists of 2 cohorts (intervention and observational cohort). At screening, eligible participants will undergo prostate-specific membrane antigen-positron emission tomography (PSMA-PET), whole-body Tc-bone scan, computed tomography (CT). Interventional Cohort, consisting of PSMA-PET positive participants, will undergoes 3 phases: Treatment Phase, a Post-treatment Phase and a Post-PSMA-PET Progression Phase. After 6-month Treatment Phase, participants will be prospectively assessed in Post-treatment Phase until PSMA-PET-positive metastatic progression is confirmed. Observational cohort will run parallelly to interventional cohort. PSMA-PET negative, participants will be observed until time-point when number of events required for analysis of primary endpoint is reached in Interventional Cohort. This cohort provides an approach to document the selection of treatments and observation of interventions in a real-life clinical practice setting. The duration of the study is estimated to be approximately 7 years.

• Study Type: Interventional
• Enrollment (Actual): 692
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Bundaberg, Australia, 4670
    • Bundaberg Hospital
  • Bundaberg, Australia, 4670
    • Hervey Bay Hospital
  • East Melbourne, Australia, 3002
    • Epworth Healthcare
  • Fitzroy, Australia, 3065
    • St Vincent's Hospital - Melbourne
  • Hurstville, Australia, 2220
    • Genesis Care Hurstville
  • North Ryde, Australia, 2109
    • Macquarie University Hospital
  • Waratah, Australia, 2298
    • Calvary Mater Newcastle
  • Wembley, Australia, 6014
    • GenesisCare Wembley
• Austria
  • Linz, Austria, 4020
    • Ordensklinikum Linz GmbH Elisabethinen
  • Salzburg, Austria, 5020
    • Universitaetsklinikum Salzburg Landeskrankenhaus
  • Vienna, Austria, 1090
    • Medizinische Universitaet Wien
• Belgium
  • Antwerp, Belgium, 2610
    • ZAS Augustinus
  • Bruges, Belgium, 8000
    • A.Z. Sint Jan
  • Ghent, Belgium, 9000
    • UZ Gent
  • Kortrijk, Belgium, 8500
    • Az Groeninge
• Brazil
  • Belo Horizonte, Brazil, 30130-100
    • Empresa Brasileira de Servicos Hospitalares - EBSERH - Hospital das Clinicas da UFMG
  • Curitiba, Brazil, 81520 060
    • Liga Paranaense de Combate ao Cancer
  • Natal, Brazil, 59075-740
    • Liga Norte Riograndense Contra O Cancer
  • Porto Alegre, Brazil, 90035-001
    • Associacao Hospitalar Moinhos de Vento
  • Porto Alegre, Brazil, 90050-170
    • Irmandade Santa Casa de Misericordia de Porto Alegre
  • Rio de Janeiro, Brazil, 22250-905
    • Oncoclinicas Rio de Janeiro S A
  • Salvador, Brazil, 41253 190
    • Hospital Sao Rafael
  • São Paulo, Brazil, 01308 901
    • Sociedade Beneficente de Senhoras Hospital Sirio Libanes
  • São Paulo, Brazil, 05652 900
    • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
  • São Paulo, Brazil, 01421-000
    • Hospital Alemao Oswaldo Cruz
  • São Paulo, Brazil, 04014-002
    • Hospital Sao Camilo Unidade Vila Mariana
• Czechia
  • Pilsen, Czechia, 305 99
    • Fakultni nemocnice Plzen, Urologicka klinika
  • Prague, Czechia, 15006
    • Fakultni nemocnice v Motole
  • Prague, Czechia, 120 00
    • Urocentrum Praha
  • Prague, Czechia, 120 00
    • Urologicka klinika 1 LF UK a VFN
• Denmark
  • Aalborg, Denmark, 9000
    • Aalborg University Hospital
  • Aarhus N, Denmark, 8200
    • Aarhus University Hospital
  • Copenhagen N, Denmark, 2200
    • Rigshospitalet
  • Herlev, Denmark, 2730
    • Gentofte Herlev Hospital
• Finland
  • Helsinki, Finland, 00290
    • Helsinki University Hospital
  • Oulu, Finland, 90220
    • Oulu University Hospital
  • Tampere, Finland, 33521
    • Tampere University Hospital
  • Turku, Finland, 20520
    • Turku University Hospital
  • Vaasa, Finland, 65130
    • Vaasa Central Hospital
• Germany
  • Berlin, Germany, 10967
    • Vivantes Klinikum Am Urban
  • Braunschweig, Germany, 38126
    • Städtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer
  • Dresden, Germany, 01307
    • Universitatsklinikum Carl Gustav Carcus Dresden
  • Essen, Germany, D-45147
    • Universitatsklinikum Essen
  • München, Germany, 81675
    • Klinikum rechts der Isar - der Technischen Universität München
  • Münster, Germany, 48149
    • Universitaetsklinikum Muenster
• Hungary
  • Budapest, Hungary, 1122
    • Orszagos Onkologiai Intezet
  • Budapest, Hungary, 1204
    • Jahn Ferenc Del-pesti Korhaz es Rendelointezet
  • Budapest, Hungary, 1076
    • Péterfy Sándor utcai Kórház
  • Budapest, Hungary, 1145
    • Budapesti Uzsoki Utcai Korhaz
  • Budapest, Hungary, 1106
    • Budapesti Bajcsy Zsilinszky Korhaz es Rendelointezet
  • Budapest, Hungary, 1125
    • Eszak Budai Szent Janos Centrumkorhaz
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont
• Italy
  • Bologna, Italy, 40138
    • Radioterapia Oncologica, A.O.U. San'T Orsola
  • Florence, Italy, 50134
    • Azienda Ospedaliero Universitaria Careggi
  • Milan, Italy, 20132
    • Ospedale San Raffaele
  • Roma, Italy, 00144
    • Istituto Nazionale Tumori Regina Elena
  • Roma, Italy, 00133
    • Fondazione Policlinico Tor Vergata
  • Roma, Italy, 00189
    • Azienda Ospedaliera Sant Andrea
• Jordan
  • Amman, Jordan, 0000
    • King Hussein Cancer Center
• Lebanon
  • Beirut, Lebanon, 11 00 2807
    • St Georges Hospital university medical centre
  • Beirut, Lebanon, 1107 2020
    • American Universitty of Beirut Medical Center
  • Byblos, Lebanon, 3
    • Notre Dame De Secours
  • Zghartā, Lebanon, 100
    • Centre Hospitalier du Nord
• Mexico
  • Durango, Mexico, 34000
    • Consultorio de Especialidad en Urologia Privado
  • León, Mexico, 37530
    • Hospital MAC Leon
  • Monterrey, Mexico, 64623
    • Avix Investigacion Clinica S C
  • Naucalpan, Mexico, 53100
    • Oncologia Integral Satelite
  • Oaxaca City, Mexico, 68020
    • Centro de Investigacion Clinica de Oaxaca
  • Puebla City, Mexico, 72530
    • Oncocenter
  • Querétaro, Mexico, 76000
    • Cuidados Oncologicos
• Poland
  • Bydgoszcz, Poland, 85 796
    • Centrum Onkologii im Prof F Lukaszczyka w Bydgoszczy
  • Elblag, Poland, 82-300
    • NU-MED Grupa S.A Centrum Radioterapii i Onkologii
  • Gdansk, Poland, 80 952
    • Uniwersyteckie Centrum Kliniczne
  • Gdynia, Poland, 81 519
    • Szpitale Pomorskie Sp z o o
  • Kielce, Poland, 25 734
    • Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
  • Koszalin, Poland, 75 581
    • Szpital Wojewodzki im Mikolaja Kopernika w Koszalinie
  • Lodz, Poland, 93 513
    • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi
  • Radom, Poland, 26-600
    • Radomskie Centrum Onkologii
  • Warsaw, Poland, 02 781
    • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
• Portugal
  • Lisbon, Portugal, 1099-023
    • Ipo Lisboa
  • Lisbon, Portugal, 1400-038
    • Fund. Champalimaud
  • Lisbon, Portugal, 1350-352
    • Hosp. Cuf Tejo
  • Lisbon, Portugal, 1449-005
    • Uls Lisboa Ocidental - Hosp. Sao Francisco Xavier
  • Lisbon, Portugal, 1500 650
    • Hosp. Da Luz Lisboa
  • Lisbon, Portugal, 1649 035
    • Uls Santa Maria - Hosp. Santa Maria
  • Porto, Portugal, 4099-001
    • Uls Santo Antonio - Hosp. Santo Antonio
  • Santa Maria da Feira, Portugal, 4520-211
    • Uls de Entre Douro E Vouga - Hosp. Sao Sebastiao
• Russia
  • Ivanovo, Russia, 153040
    • Ivanovo Regional Oncology Dispensary
  • Moscow, Russia, 105077
    • City Clinical Hospital #57
  • Moscow, Russia, 119991
    • I.M. Sechenov First Moscow State Medical University
  • Moscow, Russia, 125284
    • Hertzen Oncology Research Institute
  • Saint Petersburg, Russia, 191104
    • Leningrad Regional Oncology Dispensary
  • Saint Petersburg, Russia, 197022
    • SPb SBIH 'City Clinical Oncological Dispensary'
  • Tyumen, Russia, 625041
    • Multifunctional clinical medical center 'Medical city'
  • Yekaterinburg, Russia, 620102
    • SHI Sverdlovsk Regional Clinical Hospital #1
• Slovakia
  • Bratislava, Slovakia, 851 05
    • CUIMED - urologická ambulancia
  • Košice, Slovakia, 04191
    • Východoslovenský Onkologický Ústav
  • Martin, Slovakia, 036 59
    • Univerzitná nemocnica Martin
  • Nitra, Slovakia, 94901
    • Uroexam s.r.o.
  • Poprad, Slovakia, 05801
    • Urologicka ambulancia e.cho Poprad, s.r.o
  • Prešov, Slovakia, 08001
    • MILAB s.r.o.
  • Trenčín, Slovakia, 911 01
    • Privátna urologická ambulancia
• Spain
  • Cadiz, Spain, 11009
    • Hospital Universitario Puerto Del Mar
  • Ferrol, Spain, 15405
    • Hosp. Arquitecto Marcide
  • Jerez de la Frontera, Spain, 11407
    • Hosp. de Jerez de La Frontera
  • Madrid, Spain, 28041
    • Hosp. Univ. 12 de Octubre
  • Madrid, Spain, 28046
    • Hosp. Univ. de La Paz
  • Málaga, Spain, 29010
    • Hosp Virgen de La Victoria
  • Pamplona, Spain, 31008
    • Clinica Univ. de Navarra
  • Pamplona, Spain, 31008
    • Hosp. de Navarra
  • Seville, Spain, 41013
    • Hosp. Virgen Del Rocio
  • Valencia, Spain, 46026
    • Hosp. Univ. I Politecni La Fe
  • Zaragoza, Spain, 50009
    • Hosp. Clinico Univ. Lozano Blesa
• Sweden
  • Malmö, Sweden, 205 02
    • Urologiska Mottagningen
  • Stockholm, Sweden, 11883
    • Sodersjukhuset
  • Stockholm, Sweden, 112 19
    • Prostatacancercentrum
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01250
    • Adana Baskent Yuregir Hospital
  • Ankara, Turkey (Türkiye), 06520
    • Memorial Ankara Hastanesi
  • Ankara, Turkey (Türkiye), 06590
    • Ankara University Medical Faculty
  • Ankara, Turkey (Türkiye), 06200
    • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
  • Ankara, Turkey (Türkiye), 06230
    • Hacettepe Universitesi Hastanesi
  • Istanbul, Turkey (Türkiye), 34722
    • Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
  • Istanbul, Turkey (Türkiye), 34096
    • Istanbul University Cerrahpasa Medical Faculty
  • Istanbul, Turkey (Türkiye), 34010
    • Koc University, School of Medicine, Koc University Hospital
  • Istanbul, Turkey (Türkiye), 34147
    • Bakirkoy Training and Research Hospital
  • Istanbul, Turkey (Türkiye), 34890
    • Kartal Dr Lutfi Kirdar Egitim ve Arastirma Hastanesi
  • Izmir, Turkey (Türkiye), 35340
    • Dokuz Eylul Universitesi Arastirma ve Uygulama Hastanesi
  • Sakarya, Turkey (Türkiye), 54187
    • Sakarya Üniversitesi Tıp Fakültesi Hastanesi
• United States
  • Arizona
    • Tucson, Arizona, United States, 85741
      • Arizona Urology Specialists
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Arkansas Urology
  • Colorado
    • Lakewood, Colorado, United States, 80228
      • Colorado Clinical Research
  • Florida
    • Hialeah, Florida, United States, 33016
      • Urological Research Network
  • Indiana
    • Jeffersonville, Indiana, United States, 47130
      • First Urology, PSC
  • Michigan
    • Troy, Michigan, United States, 48084
      • Michigan Institute of Urology
  • New York
    • Syracuse, New York, United States, 13210
      • Associated Medical Professionals of Ny
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • The Urology Group
  • Oregon
    • Springfield, Oregon, United States, 97477
      • Oregon Urology Institute
  • Pennsylvania
    • Bala-Cynwyd, Pennsylvania, United States, 19004
      • MidLantic Urology
  • Texas
    • Austin, Texas, United States, 78745
      • Urology Austin
    • Houston, Texas, United States, 77027
      • Houston Metro Urology
  • Washington
    • Spokane, Washington, United States, 99202
      • Spokane Urology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histologically confirmed adenocarcinoma of the prostate
• 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:

• History of pelvic radiation for malignancy
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Radiation: Radiotherapy; Participants will receive radiotherapy (RT) with or without optional stereotactic body radiation therapy (SBRT), which will start within 4 weeks after randomization.; Drug: 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.
Experimental: 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.	Radiation: Radiotherapy; Participants will receive radiotherapy (RT) with or without optional stereotactic body radiation therapy (SBRT), which will start within 4 weeks after randomization.; Drug: 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.; Drug: Apalutamide; Participants will receive therapeutic dose of apalutamide 240 mg once daily for 180 Days.; Other Names: JNJ-56021927
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prostate specific Membrane Antigen-Positron Emission Tomography (PSMA-PET) Metastatic Progression-free Survival (ppMPFS)	ppMPFS is defined as the appearance of at least one new PSMA-PET-positive distant lesion compared with the previous scan as assessed by blinded independent central review (BICR) or death.	Up to 9 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PSA Levels at Week 26	PSA levels at week 26 will be reported.	Week 26
Time to Prostate-Specific Antigen (PSA) Progression	Time to PSA progression is defined as the time from randomization to the date of first documentation of PSA progression. PSA progression is defined as a PSA concentration above the nadir of more than 0.5 nanogram per milliliter (ng/mL), confirmed by additional measurement at least 3 Weeks later.	Up to 9 years
PSA Response Rate	PSA response rate is defined as the percentage of participants with a PSA decrease of >= 50 percent (%), >= 90% or undetectable from baseline.	Up to 9 years
Time to Loco-Regional Progression by PSMA-PET	Time to loco-regional progression by PSMA-PET as assessed by blinded independent central review (BCIR) is defined as the time from randomization to the date of the first occurrence of PSMA-PET loco-regional progression. Criteria for PSMA-PET loco-regional progression: Appearance of at least one new PSMA-PET-positive loco-regional lesion compared with the previous scan.	Up to 9 years
Overall Survival	Overall survival is defined as the time from randomization to date of death from any cause.	Up to 9 years
Prostate Cancer-Specific Survival	Prostate cancer-specific survival is defined as the time from randomization to date of death due to prostate cancer.	Up to 9 years
Number of Participants With Adverse Event (AE) and Serious Adverse Events (SAEs)	An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. An SAE is any AE that results in: death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is a suspected transmission of any infectious agent via a medicinal product.	Up to 9 years

Collaborators and Investigators

• Sponsor: Janssen Pharmaceutica N.V., Belgium
• Investigators: Study Director: Janssen Pharmaceutica N.V., Belgium Clinical Trial, Janssen Pharmaceutica N.V., Belgium

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2020
• Primary Completion (Estimated): August 27, 2029
• Study Completion (Estimated): September 15, 2031

Study Registration Dates

• First Submitted: September 17, 2020
• First Submitted That Met QC Criteria: September 17, 2020
• First Posted (Actual): September 21, 2020

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Therapeutics; Radiotherapy; apalutamide
• Other Study ID Numbers: CR108705; 56021927PCR3015 (Other Identifier: Janssen Research & Development, LLC); 2019-002957-46 (EudraCT Number); 2023-505852-23-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No