Prostate Cancer Clinical Trial

A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Prostate-Specific Membrane Antigen-Positron Emission Tomography (PSMA-PET) Positive Hormone-Sensitive Prostate Cancer Participants

Summary

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed adenocarcinoma of the prostate
Previously treated with radical prostatectomy with or without lymph node dissection and any post-operative prostate-specific antigen (PSA) measurement of less than (<) 0.1 nanogram/milliliter (ng/mL) between Week 6 and Week 20
Be able to swallow whole the study drug tablets or follow the instructions for admixing with apple sauce
Prostate specific membrane antigen-positron emission tomography (PSMA-PET) must be performed at screening: Patients who are PSMA-PET-positive for at least one loco-regional (pelvic) lesion with or without distant (extra-pelvic) lesions at screening, as determined by Blinded Independent Central Review (BICR), will be eligible to be randomized to either arm of the Interventional Cohort.The investigators will be blinded to the location of the PSMA-PET lesions after randomization and patients who are PSMA-PET-negative for any prostate cancer lesions (that is no loco-regional lesion and no distant lesion) at screening, as determined by BICR, will be eligible for inclusion in the Observational Cohort
Biochemically recurrent prostate cancer after RP with a high risk of developing metastasis defined as pathological Gleason score greater than or equal to (>=) 8 evaluated from prostate tissue specimen at radical prostatectomy, OR PSADT less than or equal to (<=) 12 months at the time of screening
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 patient should be excluded from the study. Conventional images (99mTc-bone scan and CT/MRI) from the screening will be sent to BICR for confirmation of non-metastatic prostate cancer 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) prostate cancer (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 is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

412

Study ID:

NCT04557059

Recruitment Status:

Recruiting

Sponsor:

Janssen Pharmaceutica N.V., Belgium

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There are 135 Locations for this study

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Colorado Clinical Research
Lakewood Colorado, 80228, United States
First Urology, PSC
Jeffersonville Indiana, 47130, United States
MidLantic Urology
Bala-Cynwyd Pennsylvania, 19004, United States
Houston Metro Urology
Houston Texas, 77027, United States
Flinders Medical Centre
Bedford Park , 5042, Australia
Bundaberg Hospital
Bundaberg , 4670, Australia
Hervey Bay Hospital
Bundaberg , 4670, Australia
Epworth Healthcare
East Melbourne , 3002, Australia
St Vincent's Hospital - Melbourne
Fitzroy , 3065, Australia
Genesis Care Hurstville
Hurstville , 2220, Australia
Macquarie University Hospital
North Ryde , 2109, Australia
Calvary Mater Newcastle
Waratah , 2298, Australia
GenesisCare Wembley
Wembley , 6014, Australia
Medical University Innsbruck
Innsbruck , 6020, Austria
Ordensklinikum Linz GmbH Elisabethinen
Linz , 4020, Austria
Universitätsklinikum Salzburg - Landeskrankenhaus
Salzburg , 5020, Austria
Medizinische Universität Wien
Wien , 1090, Austria
A.Z. Sint Jan
Brugge , 8000, Belgium
UZ Gent
Gent , 9000, Belgium
Az Groeninge
Kortrijk , 8500, Belgium
GZA Ziekenhuis
Wilrijk , 2610, Belgium
Cetus Oncologia
Belo Horizonte , 30110, Brazil
Liga Paranaense de Combate ao Cancer
Curitiba , 81520, Brazil
Liga Norte Riograndense Contra O Cancer
Natal , 59075, Brazil
Associação Hospitalar Moinhos de Vento
Porto Alegre , 90035, Brazil
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre , 90050, Brazil
Hospital Sao Rafael
Salvador , 41253, Brazil
Hospital Alemão Oswaldo Cruz
Sao Paulo , 01421, Brazil
Hospital Sao Camilo Unidade Vila Mariana
Sao Paulo , 04014, Brazil
Sociedade Beneficente de Senhoras - Hospital Sírio Libanês
São Paulo , 01308, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo , 05652, Brazil
Fakultni nemocnice Plzen, Urologicka klinika
Plzen , 305 9, Czechia
Urocentrum Praha
Praha 2 , 120 0, Czechia
Urologicka klinika 1.LF UK a VFN
Praha 2 , 120 0, Czechia
Fakultni nemocnice v Motole
Praha 5 , 15006, Czechia
Aalborg University Hospital
Aalborg , 9000, Denmark
Aarhus University Hospital
Aarhus N. , 8200, Denmark
Rigshospitalet
Copenhagen N , 2200, Denmark
Gentofte Herlev Hospital
Herlev , 2730, Denmark
Helsinki University Hospital
Helsinki , 290, Finland
Oulu University Hospital
Oulu , 90029, Finland
Tampere University Hospital
Tampere , 33520, Finland
Turku University Hospital
Turku , 20520, Finland
Vaasa Central Hospital
Vaasa , 65130, Finland
Städtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer
Braunschweig , 38126, Germany
Universitatsklinikum Carl Gustav Carcus Dresden
Dresden , 01307, Germany
Universitatsklinikum Essen
Essen , D-451, Germany
Universitaetsklinikum Muenster
Muenster , 48149, Germany
Klinikum rechts der Isar - der Technischen Universität München
Munchen , 81675, Germany
Péterfy Sándor utcai Kórház
Budapest , 1076, Hungary
Bajcsy-Zsilinszky Kórház és Rendelőintézet
Budapest , 1106, Hungary
Orszagos Onkologiai Intezet
Budapest , 1122, Hungary
Észak-Közép-budai Centrum, Új Szent János Kórház és Szakrendelő Budai Családközpontú
Budapest , 1125, Hungary
Uzsoki Utcai Korhaz
Budapest , 1145, Hungary
Jahn Ferenc Del-pesti Korhaz es Rendelointezet
Budapest , 1204, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen , 4032, Hungary
Radioterapia Oncologica, A.O.U. San'T Orsola
Bologna , 40138, Italy
Azienda Ospedaliero Universitaria Careggi
Firenze , 50134, Italy
Ospedale San Raffaele
Milano , 20132, Italy
Fondazione Policlinico Tor Vergata
Roma , 00133, Italy
Istituto Nazionale Tumori Regina Elena
Roma , 00144, Italy
Azienda Ospedaliera Sant Andrea
Roma , 00189, Italy
King Hussein Cancer Center
Amman , 0000, Jordan
St Georges Hospital university medical centre
Beirut , 11 00, Lebanon
American Universitty of Beirut Medical Center
Beirut , 1107 , Lebanon
Notre Dame De Secours
Jbeil , 3, Lebanon
Centre Hospitalier du Nord
Zgharta , 100, Lebanon
Consultorio de Especialidad en Urologia Privado
Durango , 34000, Mexico
Hospital Aranda de la Parra S.A. de C.V.
Leon , 37000, Mexico
Avix Investigacion Clinica, S.C.
Monterrey , 64710, Mexico
Oncologia Integral Satelite
Naucalpan , 53100, Mexico
Oncocenter
Puebla , 72530, Mexico
Centro de Estudio Clínicos de Querétaro S.C.
Queretaro , 76000, Mexico
Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy
Bydgoszcz , 85-79, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk , 80-95, Poland
Szpitale Pomorskie Sp. z o.o.
Gdynia , 81-51, Poland
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
Kielce , 25-73, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
Lodz , 93-51, Poland
Radomskie Centrum Onkologii
Radom , 26-60, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
Warszawa , 02-78, Poland
IPO Lisboa
Lisboa , 1099-, Portugal
Hospital CUF Tejo
Lisboa , 1350-, Portugal
Fundação Champalimaud
Lisboa , 1400-, Portugal
Centro Hospitalar Lisboa Ocidental - Hospital São Fracisco Xavier
Lisboa , 1449-, Portugal
Hospital da Luz
Lisboa , 1500-, Portugal
Chln - Hosp. Santa Maria
Lisboa , 1649-, Portugal
Centro Hospitalar Universitario do Porto, EPE
Porto , 4099-, Portugal
Instituto Portugues de Oncologia
Porto , 42000, Portugal
Centro Hospitalar de Entre o Douro e Vouga, E.P.E
Santa Maria da Feira , 4520-, Portugal
SHI Sverdlovsk Regional Clinical Hospital #1
Ekaterinburg , 62010, Russian Federation
Ivanovo Regional Oncology Dispensary
Ivanovo , 15304, Russian Federation
City Clinical Hospital #57
Moscow , 10507, Russian Federation
FSBSI 'N. N. Blokhin Russian Cancer Research Center'
Moscow , 11547, Russian Federation
Russian Scientific Center of Roentgenoradiology
Moscow , 11799, Russian Federation
I.M. Sechenov First Moscow State Medical University
Moscow , 11999, Russian Federation
Central Clinical Hospital
Moscow , 12135, Russian Federation
Hertzen Oncology Research Institute
Moscow , 12528, Russian Federation
Privolzhsky District Medical Center under the Federal Medico-Biological Agency
Nizhni Novgorod , 60310, Russian Federation
Clinical Oncology Dispensary
Omsk , 64401, Russian Federation
LLC Novaya Clinica
Pyatigorsk , 35750, Russian Federation
Private Medical Institution Euromedservice
Saint Petersburg , 19660, Russian Federation
SPb SBIH 'City Clinical Oncological Dispensary'
Saint Petersburg , 19702, Russian Federation
Leningrad Regional Oncology Dispensary
Saint-Petersburg , 19110, Russian Federation
Clinical hopital n/a Petra velikogo
Saint-Petersburg , 19506, Russian Federation
Russian Scientific Center of Radiology and Surgical Technologies
Sankt-Peterburg , 19775, Russian Federation
Multifunctional clinical medical center 'Medical city'
Tyumen , 62504, Russian Federation
FNsP F.D.R. Banska Bystrica
Banska Bystrica , 974 0, Slovakia
CUIMED - urologická ambulancia
Bratislava , 851 0, Slovakia
Východoslovenský Onkologický Ústav
Košice , 04191, Slovakia
Univerzitná nemocnica Martin
Martin , 036 5, Slovakia
Uroexam s.r.o.
Nitra , 94901, Slovakia
Urologicka ambulancia e.cho Poprad, s.r.o
Poprad , 05801, Slovakia
MILAB s.r.o.
Prešov , 08001, Slovakia
Privátna urologická ambulancia
Trencin , 911 0, Slovakia
Hospital Universitario Puerto Del Mar
Cadiz , 11009, Spain
Hosp. Arquitecto Marcide
Ferrol , 15405, Spain
Hosp. de Jerez de La Frontera
Jerez de la Frontera , 11407, Spain
Hosp. Univ. 12 de Octubre
Madrid , 28041, Spain
Hosp. Univ. de La Paz
Madrid , 28046, Spain
Hosp. Virgen de La Victoria
Málaga , 29010, Spain
Complejo Hosp. de Navarra
Navarra , 31008, Spain
Clinica Univ. de Navarra
Pamplona , 31008, Spain
Hosp. Virgen Del Rocio
Sevilla , 41013, Spain
Hosp. Clinico Univ. Lozano Blesa
Zaragoza , 50009, Spain
Hosp. Univ. Miguel Servet
Zaragoza , 50009, Spain
Urologiska Mottagningen
Malmö , 205 0, Sweden
Prostatacancercentrum
Stockholm , 112 1, Sweden
Södersjukhuset
Stockholm , 11883, Sweden
Adana Baskent Yuregir Hospital
Adana , 01250, Turkey
Hacettepe University Medical Faculty
Ankara , 06230, Turkey
Memorial Ankara Hastanesi
Ankara , 06520, Turkey
Ankara University Medical Faculty
Ankara , 06590, Turkey
Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara , 6200, Turkey
Koc University, School of Medicine, Koc University Hospital
Istanbul , 34010, Turkey
Istanbul University Cerrahpasa Medical Faculty
Istanbul , 34096, Turkey
Bakirkoy Training and Research Hospital
Istanbul , 34147, Turkey
Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
Istanbul , 34722, Turkey
Kartal Dr. Lutfi Kirdar Egitim ve Arastirma Hastanesi
Istanbul , 34890, Turkey
Dokuz Eylul Universitesi Tip Fakultesi
Izmir , 35340, Turkey
Sakarya Üniversitesi Tıp Fakültesi Hastanesi
Sakarya , 54187, Turkey

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

412

Study ID:

NCT04557059

Recruitment Status:

Recruiting

Sponsor:


Janssen Pharmaceutica N.V., Belgium

How clear is this clinincal trial information?

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