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

Primary Purpose

Prostatic Neoplasms

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Radiotherapy
LHRHa
Apalutamide
Sponsored by
Janssen Pharmaceutica N.V., Belgium
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Arizona Urology SpecialistsRecruiting
  • Arkansas UrologyRecruiting
  • Colorado Clinical ResearchRecruiting
  • Urological Research NetworkRecruiting
  • First Urology, PSCRecruiting
  • Michigan Institute of UrologyRecruiting
  • Associated Medical Professionals of NyRecruiting
  • The Urology GroupRecruiting
  • MidLantic UrologyRecruiting
  • Houston Metro UrologyRecruiting
  • Spokane UrologyRecruiting
  • Bundaberg HospitalRecruiting
  • Hervey Bay HospitalRecruiting
  • Epworth HealthcareRecruiting
  • St Vincent's Hospital - MelbourneRecruiting
  • Genesis Care HurstvilleRecruiting
  • Macquarie University Hospital
  • Calvary Mater NewcastleRecruiting
  • GenesisCare WembleyRecruiting
  • Ordensklinikum Linz GmbH ElisabethinenRecruiting
  • Universitätsklinikum Salzburg - LandeskrankenhausRecruiting
  • Medizinische Universität Wien
  • A.Z. Sint JanRecruiting
  • UZ GentRecruiting
  • Az GroeningeRecruiting
  • GZA ZiekenhuisRecruiting
  • Liga Paranaense de Combate ao CancerRecruiting
  • Liga Norte Riograndense Contra O CancerRecruiting
  • Associacao Hospitalar Moinhos de VentoRecruiting
  • Irmandade Santa Casa de Misericordia de Porto AlegreRecruiting
  • Hospital Sao RafaelRecruiting
  • Hospital Alemao Oswaldo CruzRecruiting
  • Hospital Sao Camilo Unidade Vila MarianaRecruiting
  • Sociedade Beneficente de Senhoras - Hospital Sírio LibanêsRecruiting
  • Fakultni nemocnice Plzen, Urologicka klinikaRecruiting
  • Urocentrum PrahaRecruiting
  • Urologicka klinika 1.LF UK a VFNRecruiting
  • Fakultni nemocnice v MotoleRecruiting
  • Aalborg University HospitalRecruiting
  • Aarhus University HospitalRecruiting
  • RigshospitaletRecruiting
  • Gentofte Herlev HospitalRecruiting
  • Oulu University HospitalRecruiting
  • Tampere University HospitalRecruiting
  • Turku University HospitalRecruiting
  • Vaasa Central HospitalRecruiting
  • Péterfy Sándor utcai KórházRecruiting
  • Bajcsy-Zsilinszky Kórház és RendelőintézetRecruiting
  • Orszagos Onkologiai IntezetRecruiting
  • Észak-Közép-budai Centrum, Új Szent János Kórház és Szakrendelő Budai CsaládközpontúRecruiting
  • Uzsoki Utcai KorhazRecruiting
  • Jahn Ferenc Del-pesti Korhaz es RendelointezetRecruiting
  • Debreceni Egyetem Klinikai KozpontRecruiting
  • Radioterapia Oncologica, A.O.U. San'T OrsolaRecruiting
  • Azienda Ospedaliero Universitaria CareggiRecruiting
  • Ospedale San RaffaeleRecruiting
  • Fondazione Policlinico Tor VergataRecruiting
  • Istituto Nazionale Tumori Regina ElenaRecruiting
  • Azienda Ospedaliera Sant AndreaRecruiting
  • King Hussein Cancer CenterRecruiting
  • St Georges Hospital university medical centreRecruiting
  • American Universitty of Beirut Medical CenterRecruiting
  • Notre Dame De SecoursRecruiting
  • Centre Hospitalier du NordRecruiting
  • Consultorio de Especialidad en Urologia PrivadoRecruiting
  • Hospital Aranda de la Parra S.A. de C.V.Recruiting
  • Avix Investigacion Clinica, S.C.Recruiting
  • Oncologia Integral SateliteRecruiting
  • Centro de Investigacion Clinica de OaxacaRecruiting
  • OncocenterRecruiting
  • Centro de Estudio Clínicos de Querétaro S.C.Recruiting
  • Centrum Onkologii im. Prof. F. Lukaszczyka w BydgoszczyRecruiting
  • NU-MED Grupa S.A Centrum Radioterapii i UsprawnianiaRecruiting
  • Uniwersyteckie Centrum KliniczneRecruiting
  • Szpitale Pomorskie Sp. z o.o.Recruiting
  • Swietokrzyskie Centrum Onkologii SPZOZ w KielcachRecruiting
  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w LodziRecruiting
  • Radomskie Centrum OnkologiiRecruiting
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut BadawczyRecruiting
  • IPO LisboaRecruiting
  • Hospital CUF TejoRecruiting
  • Fundação ChampalimaudRecruiting
  • Centro Hospitalar Lisboa Ocidental - Hospital São Fracisco XavierRecruiting
  • Hospital da LuzRecruiting
  • Chln - Hosp. Santa MariaRecruiting
  • Centro Hospitalar Universitario do Porto, EPERecruiting
  • Centro Hospitalar de Entre o Douro e Vouga, E.P.ERecruiting
  • SHI Sverdlovsk Regional Clinical Hospital #1
  • Ivanovo Regional Oncology Dispensary
  • City Clinical Hospital #57
  • I.M. Sechenov First Moscow State Medical University
  • Hertzen Oncology Research Institute
  • SPb SBIH 'City Clinical Oncological Dispensary'
  • Multifunctional clinical medical center 'Medical city'
  • CUIMED - urologická ambulanciaRecruiting
  • Východoslovenský Onkologický ÚstavRecruiting
  • Univerzitná nemocnica MartinRecruiting
  • Uroexam s.r.o.Recruiting
  • Urologicka ambulancia e.cho Poprad, s.r.oRecruiting
  • MILAB s.r.o.Recruiting
  • Privátna urologická ambulanciaRecruiting
  • Hospital Universitario Puerto Del MarRecruiting
  • Hosp. Arquitecto MarcideRecruiting
  • Hosp. de Jerez de La FronteraRecruiting
  • Hosp. Univ. 12 de OctubreRecruiting
  • Hosp. Univ. de La PazRecruiting
  • Hosp. Virgen de La VictoriaRecruiting
  • Complejo Hosp. de NavarraRecruiting
  • Clinica Univ. de NavarraRecruiting
  • Hosp. Virgen Del RocioRecruiting
  • Hosp. Clinico Univ. Lozano BlesaRecruiting
  • Urologiska MottagningenRecruiting
  • ProstatacancercentrumRecruiting
  • SödersjukhusetRecruiting
  • Adana Baskent Yuregir HospitalRecruiting
  • Hacettepe University Medical FacultyRecruiting
  • Memorial Ankara HastanesiRecruiting
  • Ankara University Medical FacultyRecruiting
  • Dr.Abdurrahman Yurtaslan Oncology Training and Research HospitalRecruiting
  • Istanbul University Cerrahpasa Medical Faculty
  • Bakirkoy Training and Research HospitalRecruiting
  • Goztepe Prof. Dr. Suleyman Yalcin Sehir HastanesiRecruiting
  • Kartal Dr. Lutfi Kirdar Egitim ve Arastirma Hastanesi
  • Dokuz Eylul Universitesi Tip FakultesiRecruiting
  • Sakarya Üniversitesi Tıp Fakültesi HastanesiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

No Intervention

Arm Label

Interventional Cohort (Group 1): RT+ LHRHa

Interventional Cohort (Group 2): RT+LHRHa + Apalutamide

Observational Cohort(Group3) PSMA-PET Negative Participants

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
PSA Levels at Week 26
PSA levels at week 26 will be reported.
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.
Overall Survival
Overall survival is defined as the time from randomization to date of death from any cause.
Prostate Cancer-Specific Survival
Prostate cancer-specific survival is defined as the time from randomization to date of death due to prostate cancer.
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.

Full Information

First Posted
September 17, 2020
Last Updated
October 10, 2023
Sponsor
Janssen Pharmaceutica N.V., Belgium
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1. Study Identification

Unique Protocol Identification Number
NCT04557059
Brief Title
A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer
Acronym
PRIMORDIUM
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 12, 2020 (Actual)
Primary Completion Date
January 28, 2030 (Anticipated)
Study Completion Date
January 28, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Pharmaceutica N.V., Belgium

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
412 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional Cohort (Group 1): RT+ LHRHa
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Interventional Cohort (Group 2): RT+LHRHa + Apalutamide
Arm Type
Experimental
Arm Description
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.
Arm Title
Observational Cohort(Group3) PSMA-PET Negative Participants
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
Participants will receive radiotherapy (RT) with or without optional stereotactic body radiation therapy (SBRT), which will start within 4 weeks after randomization.
Intervention Type
Drug
Intervention Name(s)
LHRHa
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Apalutamide
Other Intervention Name(s)
JNJ-56021927
Intervention Description
Participants will receive therapeutic dose of apalutamide 240 mg once daily for 180 Days.
Primary Outcome Measure Information:
Title
Prostate specific Membrane Antigen-Positron Emission Tomography (PSMA-PET) Metastatic Progression-free Survival (ppMPFS)
Description
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.
Time Frame
Up to 9 years
Secondary Outcome Measure Information:
Title
Time to Prostate-Specific Antigen (PSA) Progression
Description
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.
Time Frame
Up to 9 years
Title
PSA Response Rate
Description
PSA response rate is defined as the percentage of participants with a PSA decrease of >= 50 percent (%), >= 90% or undetectable from baseline.
Time Frame
Up to 9 years
Title
PSA Levels at Week 26
Description
PSA levels at week 26 will be reported.
Time Frame
Week 26
Title
Time to Loco-Regional Progression by PSMA-PET
Description
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.
Time Frame
Up to 9 years
Title
Overall Survival
Description
Overall survival is defined as the time from randomization to date of death from any cause.
Time Frame
Up to 9 years
Title
Prostate Cancer-Specific Survival
Description
Prostate cancer-specific survival is defined as the time from randomization to date of death due to prostate cancer.
Time Frame
Up to 9 years
Title
Number of Participants With Adverse Event (AE) and Serious Adverse Events (SAEs)
Description
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.
Time Frame
Up to 9 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
844-434-4210
Email
Participate-In-This-Study@its.jnj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Pharmaceutica N.V., Belgium Clinical Trial
Organizational Affiliation
Janssen Pharmaceutica N.V., Belgium
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Urology Specialists
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Individual Site Status
Recruiting
Facility Name
Arkansas Urology
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Individual Site Status
Recruiting
Facility Name
Colorado Clinical Research
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Individual Site Status
Recruiting
Facility Name
Urological Research Network
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Recruiting
Facility Name
First Urology, PSC
City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
Individual Site Status
Recruiting
Facility Name
Michigan Institute of Urology
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Individual Site Status
Recruiting
Facility Name
Associated Medical Professionals of Ny
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Individual Site Status
Recruiting
Facility Name
The Urology Group
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Individual Site Status
Recruiting
Facility Name
MidLantic Urology
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Individual Site Status
Recruiting
Facility Name
Houston Metro Urology
City
Houston
State/Province
Texas
ZIP/Postal Code
77027
Country
United States
Individual Site Status
Recruiting
Facility Name
Spokane Urology
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Individual Site Status
Recruiting
Facility Name
Bundaberg Hospital
City
Bundaberg
ZIP/Postal Code
4670
Country
Australia
Individual Site Status
Recruiting
Facility Name
Hervey Bay Hospital
City
Bundaberg
ZIP/Postal Code
4670
Country
Australia
Individual Site Status
Recruiting
Facility Name
Epworth Healthcare
City
East Melbourne
ZIP/Postal Code
3002
Country
Australia
Individual Site Status
Recruiting
Facility Name
St Vincent's Hospital - Melbourne
City
Fitzroy
ZIP/Postal Code
3065
Country
Australia
Individual Site Status
Recruiting
Facility Name
Genesis Care Hurstville
City
Hurstville
ZIP/Postal Code
2220
Country
Australia
Individual Site Status
Recruiting
Facility Name
Macquarie University Hospital
City
North Ryde
ZIP/Postal Code
2109
Country
Australia
Individual Site Status
Completed
Facility Name
Calvary Mater Newcastle
City
Waratah
ZIP/Postal Code
2298
Country
Australia
Individual Site Status
Recruiting
Facility Name
GenesisCare Wembley
City
Wembley
ZIP/Postal Code
6014
Country
Australia
Individual Site Status
Recruiting
Facility Name
Ordensklinikum Linz GmbH Elisabethinen
City
Linz
ZIP/Postal Code
4020
Country
Austria
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Salzburg - Landeskrankenhaus
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Individual Site Status
Recruiting
Facility Name
Medizinische Universität Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Completed
Facility Name
A.Z. Sint Jan
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Az Groeninge
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Individual Site Status
Recruiting
Facility Name
GZA Ziekenhuis
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Liga Paranaense de Combate ao Cancer
City
Curitiba
ZIP/Postal Code
81520-060
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Liga Norte Riograndense Contra O Cancer
City
Natal
ZIP/Postal Code
59075-740
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Associacao Hospitalar Moinhos de Vento
City
Porto Alegre
ZIP/Postal Code
90035-001
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Irmandade Santa Casa de Misericordia de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
90050-170
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Sao Rafael
City
Salvador
ZIP/Postal Code
41253-190
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Alemao Oswaldo Cruz
City
Sao Paulo
ZIP/Postal Code
01421-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Sao Camilo Unidade Vila Mariana
City
Sao Paulo
ZIP/Postal Code
04014-002
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Sociedade Beneficente de Senhoras - Hospital Sírio Libanês
City
São Paulo
ZIP/Postal Code
01308-901
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Plzen, Urologicka klinika
City
Plzen
ZIP/Postal Code
305 99
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Urocentrum Praha
City
Praha 2
ZIP/Postal Code
120 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Urologicka klinika 1.LF UK a VFN
City
Praha 2
ZIP/Postal Code
120 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice v Motole
City
Praha 5
ZIP/Postal Code
15006
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Aarhus University Hospital
City
Aarhus N.
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Rigshospitalet
City
Copenhagen N
ZIP/Postal Code
2200
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Gentofte Herlev Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Oulu University Hospital
City
Oulu
ZIP/Postal Code
90220
Country
Finland
Individual Site Status
Recruiting
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
33521
Country
Finland
Individual Site Status
Recruiting
Facility Name
Turku University Hospital
City
Turku
ZIP/Postal Code
20520
Country
Finland
Individual Site Status
Recruiting
Facility Name
Vaasa Central Hospital
City
Vaasa
ZIP/Postal Code
65130
Country
Finland
Individual Site Status
Recruiting
Facility Name
Péterfy Sándor utcai Kórház
City
Budapest
ZIP/Postal Code
1076
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Bajcsy-Zsilinszky Kórház és Rendelőintézet
City
Budapest
ZIP/Postal Code
1106
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Orszagos Onkologiai Intezet
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Észak-Közép-budai Centrum, Új Szent János Kórház és Szakrendelő Budai Családközpontú
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Uzsoki Utcai Korhaz
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Jahn Ferenc Del-pesti Korhaz es Rendelointezet
City
Budapest
ZIP/Postal Code
1204
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Radioterapia Oncologica, A.O.U. San'T Orsola
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero Universitaria Careggi
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione Policlinico Tor Vergata
City
Roma
ZIP/Postal Code
00133
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto Nazionale Tumori Regina Elena
City
Roma
ZIP/Postal Code
00144
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Sant Andrea
City
Roma
ZIP/Postal Code
00189
Country
Italy
Individual Site Status
Recruiting
Facility Name
King Hussein Cancer Center
City
Amman
ZIP/Postal Code
0000
Country
Jordan
Individual Site Status
Recruiting
Facility Name
St Georges Hospital university medical centre
City
Beirut
ZIP/Postal Code
11 00 2807
Country
Lebanon
Individual Site Status
Recruiting
Facility Name
American Universitty of Beirut Medical Center
City
Beirut
ZIP/Postal Code
1107 2020
Country
Lebanon
Individual Site Status
Recruiting
Facility Name
Notre Dame De Secours
City
Jbeil
ZIP/Postal Code
3
Country
Lebanon
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier du Nord
City
Zgharta
ZIP/Postal Code
100
Country
Lebanon
Individual Site Status
Recruiting
Facility Name
Consultorio de Especialidad en Urologia Privado
City
Durango
ZIP/Postal Code
34000
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Hospital Aranda de la Parra S.A. de C.V.
City
Leon
ZIP/Postal Code
37000
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Avix Investigacion Clinica, S.C.
City
Monterrey
ZIP/Postal Code
64710
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Oncologia Integral Satelite
City
Naucalpan
ZIP/Postal Code
53100
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Centro de Investigacion Clinica de Oaxaca
City
Oaxaca de Juárez
ZIP/Postal Code
68020
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Oncocenter
City
Puebla
ZIP/Postal Code
72530
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Centro de Estudio Clínicos de Querétaro S.C.
City
Queretaro
ZIP/Postal Code
76000
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Individual Site Status
Recruiting
Facility Name
NU-MED Grupa S.A Centrum Radioterapii i Usprawniania
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Individual Site Status
Recruiting
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Individual Site Status
Recruiting
Facility Name
Szpitale Pomorskie Sp. z o.o.
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland
Individual Site Status
Recruiting
Facility Name
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
City
Kielce
ZIP/Postal Code
25-734
Country
Poland
Individual Site Status
Recruiting
Facility Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
City
Lodz
ZIP/Postal Code
93-513
Country
Poland
Individual Site Status
Recruiting
Facility Name
Radomskie Centrum Onkologii
City
Radom
ZIP/Postal Code
26-600
Country
Poland
Individual Site Status
Recruiting
Facility Name
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Individual Site Status
Recruiting
Facility Name
IPO Lisboa
City
Lisboa
ZIP/Postal Code
1099-023
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Hospital CUF Tejo
City
Lisboa
ZIP/Postal Code
1350-352
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Fundação Champalimaud
City
Lisboa
ZIP/Postal Code
1400-038
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar Lisboa Ocidental - Hospital São Fracisco Xavier
City
Lisboa
ZIP/Postal Code
1449-005
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Hospital da Luz
City
Lisboa
ZIP/Postal Code
1500-650
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Chln - Hosp. Santa Maria
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar Universitario do Porto, EPE
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar de Entre o Douro e Vouga, E.P.E
City
Santa Maria da Feira
ZIP/Postal Code
4520-211
Country
Portugal
Individual Site Status
Recruiting
Facility Name
SHI Sverdlovsk Regional Clinical Hospital #1
City
Ekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Ivanovo Regional Oncology Dispensary
City
Ivanovo
ZIP/Postal Code
153040
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
City Clinical Hospital #57
City
Moscow
ZIP/Postal Code
105077
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
I.M. Sechenov First Moscow State Medical University
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Hertzen Oncology Research Institute
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
SPb SBIH 'City Clinical Oncological Dispensary'
City
Saint Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Multifunctional clinical medical center 'Medical city'
City
Tyumen
ZIP/Postal Code
625041
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
CUIMED - urologická ambulancia
City
Bratislava
ZIP/Postal Code
851 05
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Východoslovenský Onkologický Ústav
City
Košice
ZIP/Postal Code
04191
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Univerzitná nemocnica Martin
City
Martin
ZIP/Postal Code
036 59
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Uroexam s.r.o.
City
Nitra
ZIP/Postal Code
94901
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Urologicka ambulancia e.cho Poprad, s.r.o
City
Poprad
ZIP/Postal Code
05801
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
MILAB s.r.o.
City
Prešov
ZIP/Postal Code
08001
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Privátna urologická ambulancia
City
Trencin
ZIP/Postal Code
911 01
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Puerto Del Mar
City
Cadiz
ZIP/Postal Code
11009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Arquitecto Marcide
City
Ferrol
ZIP/Postal Code
15405
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. de Jerez de La Frontera
City
Jerez de la Frontera
ZIP/Postal Code
11407
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. de La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Virgen de La Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Complejo Hosp. de Navarra
City
Navarra
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinica Univ. de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Virgen Del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Clinico Univ. Lozano Blesa
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Urologiska Mottagningen
City
Malmö
ZIP/Postal Code
205 02
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Prostatacancercentrum
City
Stockholm
ZIP/Postal Code
112 19
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Södersjukhuset
City
Stockholm
ZIP/Postal Code
11883
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Adana Baskent Yuregir Hospital
City
Adana
ZIP/Postal Code
01250
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Hacettepe University Medical Faculty
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Memorial Ankara Hastanesi
City
Ankara
ZIP/Postal Code
06520
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ankara University Medical Faculty
City
Ankara
ZIP/Postal Code
06590
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital
City
Ankara
ZIP/Postal Code
6200
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Istanbul University Cerrahpasa Medical Faculty
City
Istanbul
ZIP/Postal Code
34096
Country
Turkey
Individual Site Status
Completed
Facility Name
Bakirkoy Training and Research Hospital
City
Istanbul
ZIP/Postal Code
34147
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Kartal Dr. Lutfi Kirdar Egitim ve Arastirma Hastanesi
City
Istanbul
ZIP/Postal Code
34890
Country
Turkey
Individual Site Status
Completed
Facility Name
Dokuz Eylul Universitesi Tip Fakultesi
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Sakarya Üniversitesi Tıp Fakültesi Hastanesi
City
Sakarya
ZIP/Postal Code
54187
Country
Turkey
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

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

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