Clinical trial • Phase III • Oncology

Apalutamide for High-risk recurrent prostate cancer previously treated with radical prostatectomy

Phase III trial of Apalutamide for High-risk recurrent prostate cancer previously treated with radical prostatectomy.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
High-risk recurrent prostate cancer previously treated with radical prostatectomy
Trial Stage
Phase III
Drug Modality
Small molecule|Radiopharmaceutical|Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
16-01-2024
First CTIS Authorization Date
21-02-2024

Trial design

Randomised, open-label, radiotherapy + lhrh agonist (androgen deprivation therapy) as rt+lhrha alone (dose and schedule not specified in provided record).-controlled Phase III trial across 73 sites in Belgium, Denmark, Czechia and others.

Randomised
Yes
Open Label
Yes
Comparator
Radiotherapy + LHRH agonist (androgen deprivation therapy) as RT+LHRHa alone (dose and schedule not specified in provided record).
Target Sample Size
183

Eligibility

Recruits 183 Participants must sign an Informed Consent Form (ICF) indicating understanding of study purpose and procedures; participants must be willing and able to adhere to protocol restrictions. Only adults (≥18 years or legal age of consent locally) are eligible. No vulnerable populations selected in the application; assent is not applicable because minors are excluded. Consent is provided by the participant; local legal consent age applies..

Vulnerable Population
Participants must sign an Informed Consent Form (ICF) indicating understanding of study purpose and procedures; participants must be willing and able to adhere to protocol restrictions. Only adults (≥18 years or legal age of consent locally) are eligible. No vulnerable populations selected in the application; assent is not applicable because minors are excluded. Consent is provided by the participant; local legal consent age applies.

Inclusion criteria

  • {"criterion_text":"- 1. Person, 18 years of age or older (or the legal age of consent in the jurisdiction in which the study is taking place).\n- 10. Criterion changed per Amendment 1. 10.1 Adequate organ function as defined by the following criteria: - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 X upper limit of normal (ULN) and total bilirubin ≤1.5 x ULN. - Serum creatinine <1.8 mg/dL. - Platelets ≥75,000/μL, without transfusion or growth factors within 1 month prior to randomization. - Hemoglobin ≥10.0 g/dL (6.21 mmol/L), without transfusion or growth factors within 1 month prior to randomization.\n- 11. Criterion changed per Amendment 1. 11.1 Be able to swallow whole the study drug tablets or follow the instructions for admixing with apple sauce.\n- 12. Criterion changed per Amendment 1. 12.1 If the participant engages in sexual activity with a person of childbearing potential, a condom must be used together with another highly effective method of contraception during the Treatment Period and for 3 months after the last dose of study drug.\n- 13. The participant must agree not to donate sperm for the purpose of reproduction during the Treatment Phase and for a minimum 3 months after receiving the last dose of study drug.\n- 14. Criterion added per Amendment 1. Participants receiving bone-loss prevention treatment with bone-sparing agents indicated for the treatment of osteoporosis at doses and dosing schedules appropriate for the treatment of osteoporosis (eg, denosumab [Prolia®], zoledronic acid [Reclast®]) must be on stable doses for at least 4 weeks before randomization.\n- 15.Criterion added per Amendment 2. Participant is indicated and planned to receive whole pelvic SRT for BCR prostate cancer.\n- 2. Signed an Informed Consent Form (ICF) indicating that the participant understands the purpose of, and procedures required for the study and is willing to participate in the study; participants must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.\n- 3. Histologically confirmed adenocarcinoma of the prostate.\n- 4.1 Criterion changed per Amendment 2. 4.2 Criterion changed per Amendment 3 4.3 Previously treated with radical prostatectomy with or without lymph node dissection and either a)For Biochemical recurrence after RP: Any post-operative PSA measurement of <0.1 ng/mL within 12 months after RP and without any PSA ≥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.\n- 5. Criterion deleted per Amendment 2\n- 6. Criterion changed per Amendment 1. 6.1 Criterion changed per Amendment 2. 6.2 Criterion changed per Amendment 3 6.3 High risk of developing metastasis defined as: a) For biochemical recurrence after RP: pathological Gleason score ≥8, evaluated from prostate tissue specimen at radical prostatectomy, OR PSADT ≤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\n- 7. Criterion changed per Amendment 1. 7.1 Criterion changed per Amendment 3 7.2 Results of PSMA-PET at screening , as determined by BICR, must be: - PSMA-PET-negative for any prostate cancer lesions (ie, no locoregional 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 distant extra-pelvic lesion(s)\n- 8. Criterion changed per Amendment 1. 8.1 Criterion changed per Amendment 2. 8.2 Criterion changed per Amendment 3 8.3 Patients 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, 99m Tc 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 screening will be evaluated locally before randomization.\n- 9. Eastern Cooperative Oncology Group Performance Status Grade 0 or 1."}

Exclusion criteria

  • {"criterion_text":"- 1. History of pelvic radiation for malignancy.\n- 10. Not applicable; criterion numbering omitted from initial protocol in error.\n- 11. Prior chemotherapy for prostate cancer.\n- 12. Active malignancies (ie, progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. The only allowed exceptions are: - Non-muscle invasive bladder cancer. - Skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured. - Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer and considered to have a very low risk of recurrence. - Malignancy that is considered cured with minimal risk of recurrence.\n- 13. Human immunodeficiency virus-positive participants with 1 or more of the following: - Not receiving highly active antiretroviral therapy - Had a change in antiretroviral therapy within 6 months of the start of screening - Receiving antiretroviral therapy that may interfere with study treatment (consult Sponsor for review of medication prior to enrollment) - CD4 count <350 at screening - AIDS-defining opportunistic infection within 6 months of start of screening\n- 14. Chronic, active or symptomatic viral hepatitis or chronic liver disease; ascites or bleeding disorders secondary to hepatic dysfunction.\n- 15. History of seizure or any condition that may predispose to seizure (including, but not limited to, prior stroke, transient ischemic attack, or loss of consciousness ≤1 year prior to randomization; brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect).\n- 16. Treatment with drugs known to lower the seizure threshold within 4 weeks prior to randomization.\n- 17. Known or suspected contraindications or hypersensitivity to apalutamide, LHRH agonist or any of the components of the formulations.\n- 18. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant.\n- 19. Criterion deleted per Amendment 1.\n- 2. Criterion deleted per Amendment 1.\n- 20.Criterion added per Amendment 2. Any evidence of prostate cancer metastasis on CT/MRI of the chest/abdomen/pelvis or 99mTc whole-body bone scan, at any time prior to screening.\n- 3. Previous treatment with ADT for prostate cancer.\n- 4. Criterion changed per Amendment 2. 4.1 Previously treated for BCR or persistent PSA after RP (previous surgical treatment of one or more loco-regional lesions is allowed).\n- 5. Prior treatment with a CYP17 inhibitor (eg, oral ketoconazole, orteronel, abiraterone acetate, galeterone) or any AR antagonist including bicalutamide, flutamide, nilutamide, apalutamide, enzalutamide or darolutamide and any other medications that may lower androgen levels (eg. estrogens, progestins, aminoglutethimide, etc.), including bilateral orchiectomy.\n- 6. Pathological finding consistent with small cell, or neuroendocrine carcinoma of the prostate.\n- 7. Any of the following within 6 months prior to firial infarction, symptomatist dose of study treatment: severe or unstable angina, myocardc congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias or New York Heart Association Class II to IV heart disease; uncomplicated deep vein thrombosis is not considered exclusionary.\n- 8. Use of 5-alpha-reductase inhibitor ≤4 weeks prior to randomization.\n- 9. Use of investigational agent ≤4 weeks prior to randomization."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- PSMA-PET metastatic progression-free survival (ppMPFS): Defined as the time from randomization to the (scan) date of metastatic progression by PSMA PET (as determined by BICR) or death from any cause.","definition_or_measurement_approach":"Defined as the time from randomization to the (scan) date of metastatic progression by PSMA PET (as determined by blinded independent central review [BICR]) or death from any cause."}

Recruitment

Planned Sample Size
183
Recruitment Window Months
110
Consent Approach
Participants must sign an Informed Consent Form (ICF) confirming understanding and willingness to participate; consent provided by participant (age ≥18 or local legal age). Multiple ICF and subject information documents are available in multiple languages (document titles indicate English, Spanish, Polish, Swedish, Portuguese, Hungarian, Italian, German, Czech, Slovak, French and Dutch variants), and separate ICFs/ICF addenda exist for interventional and observational cohorts and for withdrawn/pregnant-partner guidance.

Geography

Total Number Of Sites
73
Total Number Of Participants
290

Belgium

Earliest CTIS Part Ii Submission Date
01-02-2024
Latest Decision Or Authorization Date
23-02-2024
Processing Time Days
22
Number Of Sites
4
Number Of Participants
22

Sites

Site Name
Az St-Jan Brugge-Oostende A.V.
Department Name
Urology
Principal Investigator Name
Pieter Uvin
Principal Investigator Email
Pieter.Uvin@azsintjan.be
Contact Person Name
Pieter Uvin
Contact Person Email
Pieter.Uvin@azsintjan.be
Site Name
Algemeen Ziekenhuis Groeninge
Department Name
Urology
Principal Investigator Name
Karl Lesage
Principal Investigator Email
karl.lesage@azgroeninge.be
Contact Person Name
Karl Lesage
Contact Person Email
karl.lesage@azgroeninge.be
Site Name
GasthuisZusters Antwerpen
Department Name
Radiotherapie-oncologie
Principal Investigator Name
Piet Ost
Principal Investigator Email
piet.ost@gza.be
Contact Person Name
Piet Ost
Contact Person Email
piet.ost@gza.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Radiotherapie-oncologie
Principal Investigator Name
Valerie Fonteyne
Principal Investigator Email
valerie.fonteyne@uzgent.be
Contact Person Name
Valerie Fonteyne
Contact Person Email
valerie.fonteyne@uzgent.be

Denmark

Earliest CTIS Part Ii Submission Date
01-02-2024
Latest Decision Or Authorization Date
21-02-2024
Processing Time Days
20
Number Of Sites
4
Number Of Participants
30

Sites

Site Name
Rigshospitalet
Department Name
Copenhagen Prostate Cancer Center, Dept of Urology, Blegdamsvej 3, 2100 Copenhagen
Principal Investigator Name
Klaus Brasso
Principal Investigator Email
klaus.brasso@regionh.dk
Contact Person Name
Klaus Brasso
Contact Person Email
klaus.brasso@regionh.dk
Site Name
Herlev Hospital
Department Name
Urology department, Research, Borgmester Ib Juuls vej 23 A etage 03, 2730 Herlev
Principal Investigator Name
Rasmus Bisbjerg
Principal Investigator Email
rasmus.bisbjerg@regionh.dk
Contact Person Name
Rasmus Bisbjerg
Contact Person Email
rasmus.bisbjerg@regionh.dk
Site Name
Aarhus Universitetshospital
Department Name
Department of Urology, Palle Juul Jensens Boulevard 99, 8200 Aarhus N
Principal Investigator Name
Michael Borre
Principal Investigator Email
borre@clin.au.dk
Contact Person Name
Michael Borre
Contact Person Email
borre@clin.au.dk
Site Name
Aalborg University Hospital
Department Name
Onkologisk Afdeling, Hobrovej 18-22, 9000 Aalborg
Principal Investigator Name
Jimmi Søndergaard
Principal Investigator Email
jiso@rn.dk
Contact Person Name
Jimmi Søndergaard
Contact Person Email
jiso@rn.dk

Czechia

Earliest CTIS Part Ii Submission Date
01-02-2024
Latest Decision Or Authorization Date
23-02-2024
Processing Time Days
22
Number Of Sites
4
Number Of Participants
16

Sites

Site Name
Fakultni Nemocnice Plzen
Department Name
Urology
Principal Investigator Name
Milan Hora
Principal Investigator Email
horam@fnplzen.cz
Contact Person Name
Milan Hora
Contact Person Email
horam@fnplzen.cz
Site Name
Fakultni Nemocnice V Motole
Department Name
Oncology
Principal Investigator Name
Tomas Buchler
Principal Investigator Email
tomas.buchler@fnmotol.cz
Contact Person Name
Tomas Buchler
Contact Person Email
tomas.buchler@fnmotol.cz
Site Name
Urocentrum Praha s.r.o.
Department Name
Urology
Principal Investigator Name
Michaela Matouskova
Principal Investigator Email
matouskova@urocentrum.cz
Contact Person Name
Michaela Matouskova
Contact Person Email
matouskova@urocentrum.cz
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
Urology
Principal Investigator Name
Otakar Capoun
Principal Investigator Email
otakar.capoun@vfn.cz
Contact Person Name
Otakar Capoun
Contact Person Email
otakar.capoun@vfn.cz

Italy

Earliest CTIS Part Ii Submission Date
01-02-2024
Latest Decision Or Authorization Date
28-03-2024
Processing Time Days
56
Number Of Sites
6
Number Of Participants
19

Sites

Site Name
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Department Name
UOC Radioterapia
Principal Investigator Name
Rolando Maria D'Angelillo
Principal Investigator Email
profrmdangelillo@gmail.com
Contact Person Name
Rolando Maria D'Angelillo
Contact Person Email
profrmdangelillo@gmail.com
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
UO Radioterapia
Principal Investigator Name
Alessio Giuseppe Morganti
Principal Investigator Email
alessio.morganti2@unibo.it
Contact Person Name
Alessio Giuseppe Morganti
Contact Person Email
alessio.morganti2@unibo.it
Site Name
Azienda Ospedaliero-Universitaria Sant Andre
Department Name
UOC Urologia
Principal Investigator Name
Andrea Tubaro
Principal Investigator Email
Andrea.tubaro@uniroma1.it
Contact Person Name
Andrea Tubaro
Contact Person Email
Andrea.tubaro@uniroma1.it
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
UOC Urologia
Principal Investigator Name
Giuseppe Simone
Principal Investigator Email
giuseppe.simone@ifo.it
Contact Person Name
Giuseppe Simone
Contact Person Email
giuseppe.simone@ifo.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
UO Urologia
Principal Investigator Name
Alberto Briganti
Principal Investigator Email
briganti.alberto@unisr.it
Contact Person Name
Alberto Briganti
Contact Person Email
briganti.alberto@unisr.it
Site Name
Careggi University Hospital
Department Name
SOD Urologia Oncologica Mininvasiva Robotica e Andrologica
Principal Investigator Name
Andrea Minervini
Principal Investigator Email
andrea.minervini@unifi.it
Contact Person Name
Andrea Minervini
Contact Person Email
andrea.minervini@unifi.it

Finland

Earliest CTIS Part Ii Submission Date
01-02-2024
Latest Decision Or Authorization Date
22-02-2024
Processing Time Days
21
Number Of Sites
5
Number Of Participants
21

Sites

Site Name
Varsinais-Suomen hyvinvointialue
Department Name
Urologian poliklinikka
Principal Investigator Name
Otto Ettala
Principal Investigator Email
otto.ettala@varha.fi
Contact Person Name
Otto Ettala
Contact Person Email
otto.ettala@varha.fi
Site Name
HUS-Yhtymae
Department Name
Urologian poliklinikka
Principal Investigator Name
Antti Rannikko
Principal Investigator Email
Antti.rannikko@hus.fi
Contact Person Name
Antti Rannikko
Contact Person Email
Antti.rannikko@hus.fi
Site Name
Pohjois-Pohjanmaan hyvinvointialue
Department Name
Urologian poliklinikka
Principal Investigator Name
Hanna Ronkainen
Principal Investigator Email
Hanna.ronkainen@pohde.fi
Contact Person Name
Hanna Ronkainen
Contact Person Email
Hanna.ronkainen@pohde.fi
Site Name
Pirkanmaan hyvinvointialue
Department Name
Urologian poliklinikka
Principal Investigator Name
Teemu Murtola
Principal Investigator Email
Teemu.murtola@pirha.fi
Contact Person Name
Teemu Murtola
Contact Person Email
Teemu.murtola@pirha.fi
Site Name
Vaasa Central Hospital
Department Name
Oncology department
Principal Investigator Name
Antti Jekunen
Principal Investigator Email
Antti.jekunen@ovph.fi
Contact Person Name
Antti Jekunen
Contact Person Email
Antti.jekunen@ovph.fi

Hungary

Earliest CTIS Part Ii Submission Date
01-02-2024
Latest Decision Or Authorization Date
21-02-2024
Processing Time Days
20
Number Of Sites
7
Number Of Participants
23

Sites

Site Name
Jahn Ferenc Del-Pesti Korhaz Es Rendelointezet
Department Name
Urológiai osztály
Principal Investigator Name
Péter Tenke
Principal Investigator Email
tenke.peter@gmail.com
Contact Person Name
Péter Tenke
Contact Person Email
tenke.peter@gmail.com
Site Name
Orszagos Onkologiai Intezet
Department Name
Sugárterápiás Intézet
Principal Investigator Name
Péter Zoltán Ágoston
Principal Investigator Email
agoston.peter@oncol.hu
Contact Person Name
Péter Zoltán Ágoston
Contact Person Email
agoston.peter@oncol.hu
Site Name
Eszak-Budai Szent Janos Centrumkorhaz
Department Name
Urológiai-Sebészeti Osztály
Principal Investigator Name
Zsolt Jenő Domján
Principal Investigator Email
domjanzsoltdr70@gmail.com
Contact Person Name
Zsolt Jenő Domján
Contact Person Email
domjanzsoltdr70@gmail.com
Site Name
University Of Debrecen
Department Name
Onkológiai Klinika
Principal Investigator Name
Péter Ferenc Árkosy
Principal Investigator Email
arkosy.peter@med.unideb.hu
Contact Person Name
Péter Ferenc Árkosy
Contact Person Email
arkosy.peter@med.unideb.hu
Site Name
Budapesti Uzsoki Utcai Korhaz
Department Name
Urológiai Osztály
Principal Investigator Name
Zoltán Tóth
Principal Investigator Email
tothzee@gmail.com
Contact Person Name
Zoltán Tóth
Contact Person Email
tothzee@gmail.com
Site Name
Budapesti Bajcsy-Zsilinszky Korhaz Es Rendelointezet
Department Name
Urológiai Osztály
Principal Investigator Name
Géza Böszörményi-Nagy
Principal Investigator Email
boszormenyi@bajcsy.hu
Contact Person Name
Géza Böszörményi-Nagy
Contact Person Email
boszormenyi@bajcsy.hu
Site Name
Eszak-Budai Szent Janos Centrumkorhaz (additional listing)
Department Name
Urológiai Osztály
Principal Investigator Name
Péter Tenke
Principal Investigator Email
tenke.peter@gmail.com
Contact Person Name
Péter Tenke
Contact Person Email
tenke.peter@gmail.com

Slovakia

Earliest CTIS Part Ii Submission Date
01-02-2024
Latest Decision Or Authorization Date
21-02-2024
Processing Time Days
20
Number Of Sites
5
Number Of Participants
28

Sites

Site Name
Univerzitna Nemocnica Martin
Department Name
Urological Clinic
Principal Investigator Name
Jan Kliment
Principal Investigator Email
kliment@jfmed.uniba.sk
Contact Person Name
Jan Kliment
Contact Person Email
kliment@jfmed.uniba.sk
Site Name
Uroexam spol. s r.o.
Department Name
Private practice Urology
Principal Investigator Name
Marek Brezovsky
Principal Investigator Email
brezovsky@yahoo.com
Contact Person Name
Marek Brezovsky
Contact Person Email
brezovsky@yahoo.com
Site Name
Milab s.r.o.
Department Name
Private practice Urology
Principal Investigator Name
Ivan Mincik
Principal Investigator Email
mincik.ivan@gmail.com
Contact Person Name
Ivan Mincik
Contact Person Email
mincik.ivan@gmail.com
Site Name
Privatna Urologicka Ambulancia s.r.o.
Department Name
Private practice Urology
Principal Investigator Name
Roman Sokol
Principal Investigator Email
roman.sokol@urology.sk
Contact Person Name
Roman Sokol
Contact Person Email
roman.sokol@urology.sk
Site Name
Vychodoslovensky Onkologicky Ustav a.s.
Department Name
Radiation Oncology
Principal Investigator Name
Pavol Dubinsky
Principal Investigator Email
dubinsky@vou.sk
Contact Person Name
Pavol Dubinsky
Contact Person Email
dubinsky@vou.sk

Portugal

Earliest CTIS Part Ii Submission Date
01-02-2024
Latest Decision Or Authorization Date
22-02-2024
Processing Time Days
21
Number Of Sites
7
Number Of Participants
12

Sites

Site Name
Hospital De Santa Maria E.P.E.
Department Name
urology
Principal Investigator Name
José Palma dos Reis
Principal Investigator Email
jpalmareis@campus.ul.pt
Contact Person Name
José Palma dos Reis
Contact Person Email
jpalmareis@campus.ul.pt
Site Name
Hospital Cuf Tejo S.A.
Department Name
urology
Principal Investigator Name
Estevão Lima
Principal Investigator Email
estevao.lima@cuf.pt
Contact Person Name
Estevão Lima
Contact Person Email
estevao.lima@cuf.pt
Site Name
Centro Hospitalar De Entre O Douro E Vouga E.P.E.
Department Name
Oncology
Principal Investigator Name
Sofia Amorim
Principal Investigator Email
sof.amorim@gmail.com
Contact Person Name
Sofia Amorim
Contact Person Email
sof.amorim@gmail.com
Site Name
Champalimaud Clinical Centre
Department Name
Oncology
Principal Investigator Name
Nuno Vau
Principal Investigator Email
nuno.vau@fundacaochampalimaud.pt
Contact Person Name
Nuno Vau
Site Name
Hospital Da Luz S.A.
Department Name
Oncology
Principal Investigator Name
Teresa Timóteo
Principal Investigator Email
teresa.timoteo@gmail.com
Contact Person Name
Teresa Timóteo
Contact Person Email
teresa.timoteo@gmail.com
Site Name
Centro Hospitalar Universitario De Santo Antonio E.P.E.
Department Name
Urology
Principal Investigator Name
Frederico Teves
Principal Investigator Email
fredericoteves@gmail.com
Contact Person Name
Frederico Teves
Contact Person Email
fredericoteves@gmail.com
Site Name
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.
Department Name
urology
Principal Investigator Name
Rodrigo Ramos
Principal Investigator Email
rodrigo.brito.ramos@gmail.com
Contact Person Name
Rodrigo Ramos
Contact Person Email
rodrigo.brito.ramos@gmail.com

Germany

Earliest CTIS Part Ii Submission Date
01-02-2024
Latest Decision Or Authorization Date
23-02-2024
Processing Time Days
22
Number Of Sites
6
Number Of Participants
5

Sites

Site Name
Technische Universitat Dresden
Department Name
Klinik und Poliklinik fuer Urologie
Principal Investigator Name
Christian Thomas
Contact Person Name
Christian Thomas
Site Name
Staedtisches Klinikum Braunschweig gGmbH
Department Name
Klinik fuer Urologie und Uroonkologie, Salzdahlumer Str. 90, 38126 Brunswick
Principal Investigator Name
Peter Hammerer
Principal Investigator Email
p.hammerer@skbs.de
Contact Person Name
Peter Hammerer
Contact Person Email
p.hammerer@skbs.de
Site Name
Klinikum rechts der Isar der TU Muenchen AöR
Department Name
RadioOnkologie & Strahlentherapie
Principal Investigator Name
Stephanie Combs
Principal Investigator Email
Stephanie.combs@tum.de
Contact Person Name
Stephanie Combs
Contact Person Email
Stephanie.combs@tum.de
Site Name
Universitaet Muenster
Department Name
Urologie
Principal Investigator Name
Martin Boegemann
Principal Investigator Email
martin.boegemann@ukmuenster.de
Contact Person Name
Martin Boegemann
Contact Person Email
martin.boegemann@ukmuenster.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
Klinik fuer Urologie
Principal Investigator Name
Boris Hadaschik
Principal Investigator Email
boris.hadaschik@uk-essen.de
Contact Person Name
Boris Hadaschik
Contact Person Email
boris.hadaschik@uk-essen.de
Site Name
Vivantes Netzwerk fuer Gesundheit GmbH
Department Name
Klinik fuer Urologie
Principal Investigator Name
Stefan Hinz
Principal Investigator Email
stefan.hinz@vivantes.de
Contact Person Name
Stefan Hinz
Contact Person Email
stefan.hinz@vivantes.de

Austria

Earliest CTIS Part Ii Submission Date
01-02-2024
Latest Decision Or Authorization Date
26-03-2024
Processing Time Days
54
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH
Department Name
Urology
Principal Investigator Name
Thomas Kunit
Principal Investigator Email
t.kunit@salk.at
Contact Person Name
Thomas Kunit
Contact Person Email
t.kunit@salk.at
Site Name
Ordensklinikum Linz GmbH
Department Name
Urology
Principal Investigator Name
Ferdinand Luger
Principal Investigator Email
ferdinand.luger@ordensklinikum.at
Contact Person Name
Ferdinand Luger

Spain

Earliest CTIS Part Ii Submission Date
01-02-2024
Latest Decision Or Authorization Date
22-02-2024
Processing Time Days
21
Number Of Sites
11
Number Of Participants
61

Sites

Site Name
Area Sanitaria De Ferrol
Department Name
Urology
Principal Investigator Name
Andrés Rodríguez
Principal Investigator Email
arodri68@gmail.com
Contact Person Name
Andrés Rodríguez
Contact Person Email
arodri68@gmail.com
Site Name
Hospital Clinico Universitario Lozano Blesa
Department Name
Urology
Principal Investigator Name
Jose Ignacio Hijazo
Principal Investigator Email
j.i.hijazo@gmail.com
Contact Person Name
Jose Ignacio Hijazo
Contact Person Email
j.i.hijazo@gmail.com
Site Name
Clinica Universidad De Navarra
Department Name
Urology
Principal Investigator Name
Marcos Torres
Principal Investigator Email
mtroca@unav.es
Contact Person Name
Marcos Torres
Contact Person Email
mtroca@unav.es
Site Name
Hospital Universitario 12 De Octubre
Department Name
Urology
Principal Investigator Name
Alfredo Rodriguez Antolin
Principal Investigator Email
arantolin@yahoo.es
Contact Person Name
Alfredo Rodriguez Antolin
Contact Person Email
arantolin@yahoo.es
Site Name
Hospital Universitario De Navarra
Department Name
Urology
Principal Investigator Name
Francisco Lozano
Principal Investigator Email
urologiahc@navarra.es
Contact Person Name
Francisco Lozano
Contact Person Email
urologiahc@navarra.es
Site Name
Hospital De Jerez De La Frontera
Department Name
Urology
Principal Investigator Name
Álvaro Juarez
Principal Investigator Email
alvaro.juarez01@gmail.com
Contact Person Name
Álvaro Juarez
Contact Person Email
alvaro.juarez01@gmail.com
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
onco-radiotherapist
Principal Investigator Name
Rafael Ordoñez
Principal Investigator Email
rafaelordm@gmail.com
Contact Person Name
Rafael Ordoñez
Contact Person Email
rafaelordm@gmail.com
Site Name
Hospital Universitario La Paz
Department Name
Urology
Principal Investigator Name
Estefanía Linares
Principal Investigator Email
estefania.linares@salud.madrid.org
Contact Person Name
Estefanía Linares
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Urology
Principal Investigator Name
Ignacio Osmán García
Principal Investigator Email
ignacio.osman.sspa@juntadeandalucia.es
Contact Person Name
Ignacio Osmán García
Site Name
Hospital Universitario Puerta Del Mar
Department Name
Urology
Principal Investigator Name
Jose Luis Alvarez Ossorio Fernandez
Principal Investigator Email
urossorio@gmail.com
Contact Person Name
Jose Luis Alvarez Ossorio Fernandez
Contact Person Email
urossorio@gmail.com
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
onco-radiotherapist
Principal Investigator Name
Antonio José Conde
Principal Investigator Email
antoniojconde@gmail.com
Contact Person Name
Antonio José Conde
Contact Person Email
antoniojconde@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
01-02-2024
Latest Decision Or Authorization Date
20-03-2024
Processing Time Days
48
Number Of Sites
9
Number Of Participants
43

Sites

Site Name
Kliniki Neuroradiochirurgii Sp. z o.o.
Department Name
Radomskie Centrum Onkologii, Kliniczny Oddzial Radioterapii
Principal Investigator Name
Jaroslaw Lyczek
Principal Investigator Email
jaroslawlyczek@wp.pl
Contact Person Name
Jaroslaw Lyczek
Contact Person Email
jaroslawlyczek@wp.pl
Site Name
Szpitale Pomorskie Sp. z o.o.
Department Name
Oddzial Radioterapii
Principal Investigator Name
Dorota Filarska
Principal Investigator Email
dfilarska@szpitalepomorskie.eu
Contact Person Name
Dorota Filarska
Contact Person Email
dfilarska@szpitalepomorskie.eu
Site Name
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
Department Name
Klinika Radioterapii
Principal Investigator Name
Jacek Sadowski
Principal Investigator Email
jj999@op.pl
Contact Person Name
Jacek Sadowski
Contact Person Email
jj999@op.pl
Site Name
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Department Name
Oddzial Dzienny Chemioterapii
Principal Investigator Name
Mariusz Kwiatkowski
Principal Investigator Email
mariusz.kwiatkowski@swk.med.pl
Contact Person Name
Mariusz Kwiatkowski
Contact Person Email
mariusz.kwiatkowski@swk.med.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Onkologii i Radioterapii
Principal Investigator Name
Renata Zaucha
Principal Investigator Email
renata.zaucha@gmail.com
Contact Person Name
Renata Zaucha
Contact Person Email
renata.zaucha@gmail.com
Site Name
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Department Name
Katedra i Klinika Onkologii i Brachyterapii
Principal Investigator Name
Roman Makarewicz
Principal Investigator Email
makarewiczr@co.bydgoszcz.pl
Contact Person Name
Roman Makarewicz
Contact Person Email
makarewiczr@co.bydgoszcz.pl
Site Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Department Name
Oddzial Brachyterapii
Principal Investigator Name
Michal Maslowski
Principal Investigator Email
maslowskimichal@gmail.com
Contact Person Name
Michal Maslowski
Contact Person Email
maslowskimichal@gmail.com
Site Name
Nu Med Grupa S.A.
Department Name
Centrum Radioterapii i Usprawniania
Principal Investigator Name
Barbara Szostakiewicz
Principal Investigator Email
barbara.szostakiewicz@nu-med.pl
Contact Person Name
Barbara Szostakiewicz
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Zaklad Brachyterapii
Principal Investigator Name
Mateusz Dabkowski
Principal Investigator Email
Mateusz.Dabkowski@pib-nio.pl
Contact Person Name
Mateusz Dabkowski
Contact Person Email
Mateusz.Dabkowski@pib-nio.pl

Sweden

Earliest CTIS Part Ii Submission Date
01-02-2024
Latest Decision Or Authorization Date
22-02-2024
Processing Time Days
21
Number Of Sites
3
Number Of Participants
8

Sites

Site Name
Capio S:t Goerans Sjukhus AB
Department Name
Prostatacancercentrum, Sankt Göransplan 1, 11219 Stockholm
Principal Investigator Name
Hong Sjolinder
Principal Investigator Email
hong.sjolinder@capiostgoran.se
Contact Person Name
Hong Sjolinder
Contact Person Email
hong.sjolinder@capiostgoran.se
Site Name
Soedersjukhuset AB
Department Name
Onkologiska kliniken, Sjukhusbacken 10, 11883 Stockholm
Principal Investigator Name
Chunde Li
Principal Investigator Email
chunde.li@regionstockholm.se
Contact Person Name
Chunde Li
Contact Person Email
chunde.li@regionstockholm.se
Site Name
Region Skane Skanes Universitetssjukhus
Department Name
Department of Urology, Jan Waldenströms gata 5, 20502 Malmö
Principal Investigator Name
Anders Bjartell
Principal Investigator Email
anders.bjartell@med.lu.se
Contact Person Name
Anders Bjartell
Contact Person Email
anders.bjartell@med.lu.se

Sponsor

Primary sponsor

Full Name
Janssen - Cilag International
Organisation Type
Pharmaceutical company
Country Of Registered Address
Belgium

Contract research organisations

Name
Tata Consultancy Services Limited
Responsibilities
sponsorDuties code: 7
Name
Signant Health Global LLC
Responsibilities
sponsorDuties code: 3
Name
Perceptive Informatics Inc.
Responsibilities
Medical image analysis/ review - X-ray, MRI,ultrasound, etc.

Third parties

  • {"country":"India","full_name":"Tata Consultancy Services Limited","duties_or_roles":"sponsorDuties code: 7","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"sponsorDuties code: 3","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Medical image analysis/ review - X-ray, MRI,ultrasound, etc.","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
JNJ-56021927
Active Substance
Apalutamide
Modality
Small molecule
Routes Of Administration
Oral
Route
ORAL USE
Combination Treatment
Yes

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