Clinical trial • Phase III • Oncology

ENZALUTAMIDE for Prostate cancer|High-risk non-metastatic prostate cancer

Phase III trial of ENZALUTAMIDE for Prostate cancer|High-risk non-metastatic prostate cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Prostate cancer|High-risk non-metastatic prostate cancer
Trial Stage
Phase III
Drug Modality
Small molecule|Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
17-06-2024
First CTIS Authorization Date
19-07-2024

Trial design

Randomised, arms include: enzalutamide (xtandi - 40 mg soft capsules; active substance enzalutamide; max daily dose reported 160 mg) plus leuprorelin acetate (subcutaneous use; max total dose amount reported 22.5 mg); enzalutamide monotherapy (xtandi - 40 mg soft capsules); placebo for enzalutamide 40 mg soft gelatin capsule plus leuprorelin acetate. specific schedules not specified in the available ctis data.-controlled Phase III trial in Denmark, Austria, Italy and others.

Randomised
Yes
Comparator
Arms include: Enzalutamide (Xtandi - 40 mg soft capsules; active substance enzalutamide; max daily dose reported 160 mg) plus Leuprorelin acetate (subcutaneous use; max total dose amount reported 22.5 mg); Enzalutamide monotherapy (Xtandi - 40 mg soft capsules); Placebo for Enzalutamide 40 mg soft gelatin capsule plus Leuprorelin acetate. Specific schedules not specified in the available CTIS data.
Target Sample Size
702

Eligibility

Recruits 702 No vulnerable population selected. Trial enrols adults (Age 18 years or older) who must be willing and able to provide informed consent; no assent procedures described..

Pregnancy Exclusion
Throughout the study, the patient must use a condom if having sex with a pregnant woman.
Vulnerable Population
No vulnerable population selected. Trial enrols adults (Age 18 years or older) who must be willing and able to provide informed consent; no assent procedures described.

Inclusion criteria

  • {"criterion_text":"- Age 18 years or older and willing and able to provide informed consent.\n- Throughout study, the patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (1 of which must include a condom as a barrier method of contraception) from screening through 3 months after the last dose of study drug or per local guidelines where these require additional description of contraceptive methods. Two acceptable methods of birth control thus include the following: ● Condom (barrier method is required) AND ● One of the following is required: – Established and ongoing use of oral, injected, or implanted hormonal method of contraception by the female partner – Placement of an intrauterine device or intrauterine system by the female partner – Additional barrier method including contraceptive sponge and occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository by the female partner – Tubal ligation in the female partner performed at least 6 months before screening – Vasectomy or other procedure resulting in infertility (eg, bilateral orchiectomy), performed at least 6 months before screening\n- Throughout the study, the patient must use a condom if having sex with a pregnant woman.\n- Must agree not to donate sperm from first dose of study drug through 3 months after the last dose of study drug.\n- Histologically or cytologically confirmed adenocarcinoma of the prostate at initial biopsy, without neuroendocrine differentiation, signet cell, or small cell features.\n- Prostate cancer initially treated by radical prostatectomy or radiotherapy (including brachytherapy) or both, with curative intent. Prostate cryoablation is not considered definitive therapy for this study, but its prior use is not exclusionary.\n- PSA doubling time ≤9 months as calculated by the sponsor.\n- Screening PSA by the central laboratory ≥1 ng/mL for patients who had radical prostatectomy (with or without radiotherapy) as primary treatment for prostate cancer and at least 2 ng/mL above the nadir for patients who had radiotherapy only as primary treatment for prostate cancer.\n- Serum testosterone ≥150 ng/dL (5.2 nmol/L) at screening.\n- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening.\n- Estimated life expectancy of ≥12 months.\n- Able to swallow the study drug and comply with study requirements."}

Exclusion criteria

  • {"criterion_text":"- Prior or present evidence of distant metastatic disease as assessed by computed tomography (CT) or magnetic resonance imaging (MRI) or chest x-ray for soft tissue disease and whole-body radionuclide bone scan for bone disease. Patients with soft tissue pelvic disease may be eligible if the short axis of the largest lymph node is < 20 mm for lymph nodes below aortic bifurcation. If the screening bone scan shows a lesion suggestive of metastatic disease, the patient will be eligible only if a second imaging modality (plain film, CT, MRI) does not show bone metastasis. If the imaging results are equivocal or consistent with metastasis by central radiology review, the patient is not eligible for enrollment. Positron-emission tomography (PET) is not an evaluable imaging modality for this study.\n- Known or suspected brain metastasis or active leptomeningeal disease.\n- History of another invasive cancer within 3 years before screening, with the exception of fully treated cancers with a remote probability of recurrence. The medical monitor and investigator must agree that the possibility of recurrence is remote.\n- Absolute neutrophil count <1500/µL, platelet count <100,000/µL, or hemoglobin <10 g/dL (6.2 mmol/L) at screening. NOTE: May not have received any growth factors or blood transfusions within 7 days before the hematology values obtained at screening.\n- Total bilirubin (TBili) ≥1.5-times the upper limit of normal (except patients with documented Gilbert’s disease), or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2.5-times the upper limit of normal at screening.\n- Creatinine >2 mg/dL (177 µmol/L) at screening.\n- Albumin <3.0 g/dL (30 g/L) at screening.\n- History of seizure or any condition that may predispose to seizure (eg, prior cortical stroke or significant brain trauma). History of loss of consciousness (unless of cardiac origin) or transient ischemic attack within 12 months before randomization.\n- Clinically significant cardiovascular disease including the following: -Myocardial infarction within 6 months before screening; -Unstable angina within 3 months before screening; -New York Heart Association class III or IV congestive heart failure or a history of New York Heart Association class III or IV congestive heart failure unless a screening echocardiogram or multigated acquisition scan performed within 3 months before the randomization date demonstrates a left ventricular ejection fraction ≥45%; -History of clinically significant ventricular arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes); -History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place; -Hypotension as indicated by systolic blood pressure <86 mm Hg at screening; -Bradycardia as indicated by a heart rate of ≤45 beats per minute on the screening electrocardiogram (ECG); -Uncontrolled hypertension as indicated by a minimum of 2 consecutive blood pressure measurements showing systolic blood pressure >170 mm Hg or diastolic blood pressure >105 mm Hg at screening.\n- Gastrointestinal disorder affecting absorption.\n- Hypersensitivity reaction to enzalutamide or any of the capsule components, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene.\n- Prior hormonal therapy. Neoadjuvant/adjuvant therapy to treat prostate cancer ≤36 months in duration and ≥9 months before randomization, or a single dose or a short course (≤6 months) of hormonal therapy given for rising PSA ≥9 months before randomization is allowed.\n- Contraindication to the use of leuprolide, such as a previous hypersensitivity reaction to an LHRH analogue or any of the excipients in the leuprolide injection.\n- Ongoing drug or alcohol abuse as per investigator judgment.\n- Any concurrent disease, infection, or comorbid condition that interferes with the ability of the patient to participate in the study, which places the patient at undue risk, or complicates the interpretation of data, in the opinion of the investigator or medical monitor.\n- Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, or enzalutamide for prostate cancer.\n- Prior systemic biologic therapy, including immunotherapy, for prostate cancer.\n- Major surgery within 4 weeks before randomization date.\n- Treatment with 5-alfa reductase inhibitors (finasteride, dutasteride) within 4 weeks of randomization.\n- For patients who had a prior prostatectomy, a suitable candidate for salvage radiotherapy as determined by the investigator in consideration of appropriate guidelines (eg, American Society for Radiation Oncology/American Urological Association [ASTRO/AUA]; European Association of Urology [EAU]).\n- Participation in a clinical study of an investigational agent that inhibits the androgen receptor or androgen synthesis (eg, TAK-700, ARN-509, ODM-201); patients who received placebo are allowed.\n- Use of any other investigational agent within 4 weeks before randomization date."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- To evaluate efficacy of the combination of enzalutamide plus leuprolide versus placebo plus leuprolide, as measured by MFS.","definition_or_measurement_approach":"Measured by MFS (metastasis-free survival)."}

Secondary endpoints

  • {"endpoint_text":"- Time to PSA progression: Time to first use of new antineoplastic therapy; Overall survival.","definition_or_measurement_approach":"Time-to-event endpoints: time to PSA progression, time to first use of new antineoplastic therapy, and overall survival (as stated)."}
  • {"endpoint_text":"- To evaluate efficacy, as measured by MFS between enzalutamide monotherapy versus placebo plus leuprolide.","definition_or_measurement_approach":"Measured by MFS (metastasis-free survival)."}

Recruitment

Planned Sample Size
702
Recruitment Window Months
132
Consent Approach
Participants must be aged ≥18 years and 'willing and able to provide informed consent.' Subject information and informed consent forms are listed for multiple countries and languages in the CTIS documents (examples include Danish, German/Austrian, Italian, Slovak, Polish, Swedish, French, Dutch, Spanish, Finnish), indicating country-specific information and consent documents. No assent process for minors is described.

Geography

Total Number Of Sites
63
Total Number Of Participants
366

Denmark

Latest Decision Or Authorization Date
25-07-2024
Number Of Sites
3
Number Of Participants
30

Sites

Site Name
Rigshospitalet
Department Name
Urology
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
Lillebaelt Hospital
Department Name
Urology
Principal Investigator Name
Bettina Norby
Principal Investigator Email
bettina.noerby@rsyd.dk
Contact Person Name
Bettina Norby
Contact Person Email
bettina.noerby@rsyd.dk
Site Name
Aarhus Universitetshospital
Department Name
Urology
Principal Investigator Name
Michael Borre
Principal Investigator Email
borre@clin.au.dk
Contact Person Name
Michael Borre
Contact Person Email
borre@clin.au.dk

Austria

Latest Decision Or Authorization Date
23-07-2024
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
Department Name
Department of Urology and Andrology
Principal Investigator Name
Lukas Lusuardi
Principal Investigator Email
l.lusuardi@salk.at
Contact Person Name
Lukas Lusuardi
Contact Person Email
l.lusuardi@salk.at
Site Name
Medical University Of Vienna
Department Name
Department of Medicine
Principal Investigator Name
Michael W. Krainer
Principal Investigator Email
michael.krainer@meduniwien.ac.at
Contact Person Name
Michael W. Krainer
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

Italy

Latest Decision Or Authorization Date
31-07-2024
Number Of Sites
7
Number Of Participants
30

Sites

Site Name
Azienda Provinciale Per I Servizi Sanitari
Department Name
Divisione di Oncologia Medica
Principal Investigator Name
Orazio Caffo
Principal Investigator Email
orazio.caffo@apss.tn.it
Contact Person Name
Orazio Caffo
Contact Person Email
orazio.caffo@apss.tn.it
Site Name
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Department Name
U.O. di Oncologia Medica
Principal Investigator Name
Consuelo Buttigliero
Principal Investigator Email
consuelo.buttigliero@gmail.com
Contact Person Name
Consuelo Buttigliero
Contact Person Email
consuelo.buttigliero@gmail.com
Site Name
Azienda Socio Sanitaria Territoriale Di Cremona
Department Name
U.O. Oncologia
Principal Investigator Name
Bruno Perrucci
Principal Investigator Email
bruno.perrucci@asst-cremona.it
Contact Person Name
Bruno Perrucci
Contact Person Email
bruno.perrucci@asst-cremona.it
Site Name
San Camillo Forlanini Hospital
Department Name
Dipartimento di Oncologia Medica
Principal Investigator Name
Antonietta D’Alessio
Principal Investigator Email
adalessio@scamilloforlanini.rm.it
Contact Person Name
Antonietta D’Alessio
Site Name
Azienda Unita Sanitaria Locale Della Romagna (Faenza)
Department Name
U. O. di Oncologia Medica
Principal Investigator Name
Francesco Carrozza
Principal Investigator Email
francesco.carrozza@auslromagna.it
Contact Person Name
Francesco Carrozza
Site Name
Azienda Unita Sanitaria Locale Della Romagna (Rimini)
Department Name
U.O. Oncologia
Principal Investigator Name
Davide Tassinari
Principal Investigator Email
davide.tassinari@auslromagna.it
Contact Person Name
Davide Tassinari
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Oncologia
Principal Investigator Name
Giuseppe Schepisi
Principal Investigator Email
giuseppe.schepisi@irst.emr.it
Contact Person Name
Giuseppe Schepisi
Contact Person Email
giuseppe.schepisi@irst.emr.it

Slovakia

Latest Decision Or Authorization Date
19-07-2024
Number Of Sites
5
Number Of Participants
45

Sites

Site Name
Univerzitna Nemocnica Martin
Department Name
Urologicka klinika
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
Vychodoslovensky Onkologicky Ustav a.s.
Department Name
Oddelenie radiacnej onkologie
Principal Investigator Name
Pavol Dubinsky
Principal Investigator Email
dubinsky@vou.sk
Contact Person Name
Pavol Dubinsky
Contact Person Email
dubinsky@vou.sk
Site Name
Cuimed s.r.o.
Department Name
Urologicka ambulancia
Principal Investigator Name
Frederico Goncalves
Principal Investigator Email
cuimed1@gmail.com
Contact Person Name
Frederico Goncalves
Contact Person Email
cuimed1@gmail.com
Site Name
Milab s.r.o.
Department Name
Urocentrum
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
Uroexam spol. s r.o.
Department Name
Urologicka ambulancia
Principal Investigator Name
Jozef Marko
Principal Investigator Email
studiaur@yahoo.com
Contact Person Name
Jozef Marko
Contact Person Email
studiaur@yahoo.com

Poland

Latest Decision Or Authorization Date
30-08-2024
Number Of Sites
4
Number Of Participants
6

Sites

Site Name
EMC Instytut Medyczny S.A.
Department Name
Urology
Principal Investigator Name
Piotr Szulc
Principal Investigator Email
urolog@piotrszulc.com
Contact Person Name
Piotr Szulc
Contact Person Email
urolog@piotrszulc.com
Site Name
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o.
Department Name
Oddzial Urologiczny
Principal Investigator Name
Jacek Olubiec
Principal Investigator Email
olubiecjacek@wp.pl
Contact Person Name
Jacek Olubiec
Contact Person Email
olubiecjacek@wp.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Onkologii i Radioterapii
Principal Investigator Name
Jacek Jassem
Principal Investigator Email
jjassem@gumed.edu.pl
Contact Person Name
Jacek Jassem
Contact Person Email
jjassem@gumed.edu.pl
Site Name
Kujawsko-Pomorskie Centrum Urologicznw Sp z o.o
Department Name
Urology
Principal Investigator Name
Tomasz Drewa
Principal Investigator Email
tomaszdrewa@wp.pl
Contact Person Name
Tomasz Drewa
Contact Person Email
tomaszdrewa@wp.pl

Sweden

Latest Decision Or Authorization Date
22-07-2024
Number Of Sites
7
Number Of Participants
39

Sites

Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
Urologmottagningen/Kliniska Prövningsenheten
Principal Investigator Name
Johan Stranne
Principal Investigator Email
johan.stranne@vgregion.se
Contact Person Name
Johan Stranne
Contact Person Email
johan.stranne@vgregion.se
Site Name
Soedersjukhuset AB
Department Name
Urologiska kliniken
Principal Investigator Name
Ulf Norming
Principal Investigator Email
ulf.norming@regionstockholm.se
Contact Person Name
Ulf Norming
Contact Person Email
ulf.norming@regionstockholm.se
Site Name
Akademiska sjukhuset
Department Name
Verksamhetsområde urologi/Urologmottagningen
Principal Investigator Name
Michael Häggman
Principal Investigator Email
michael.haggman@akademiska.se
Contact Person Name
Michael Häggman
Contact Person Email
michael.haggman@akademiska.se
Site Name
Norrlands Universitetssjukhus
Department Name
Urologkliniken
Principal Investigator Name
Börje Ljungberg
Principal Investigator Email
borje.ljungberg@umu.se
Contact Person Name
Börje Ljungberg
Contact Person Email
borje.ljungberg@umu.se
Site Name
Skånes Universitetssjukhus Malmö
Department Name
Urologisektionen, Verksamhetsområde kirurgi-urologi
Principal Investigator Name
Anders Bjartell
Principal Investigator Email
anders.bjartell@skane.se
Contact Person Name
Anders Bjartell
Contact Person Email
anders.bjartell@skane.se
Site Name
Karolinska University Hospital
Department Name
Urologiska Kliniken
Principal Investigator Name
Anna Lantz
Principal Investigator Email
anna.lantz@regionstockholm.se
Contact Person Name
Anna Lantz
Contact Person Email
anna.lantz@regionstockholm.se
Site Name
Universitetssjukhuset Örebro
Department Name
Urologmottagningen
Principal Investigator Name
Pernilla Sundqvist
Principal Investigator Email
pernilla.sundqvist@regionorebrolan.se
Contact Person Name
Pernilla Sundqvist

France

Latest Decision Or Authorization Date
27-08-2024
Number Of Sites
12
Number Of Participants
44

Sites

Site Name
Institut Mutualiste Montsouris
Department Name
Surgery
Principal Investigator Name
François Rozet
Principal Investigator Email
francois.rozet@imm.fr
Contact Person Name
François Rozet
Contact Person Email
francois.rozet@imm.fr
Site Name
Centre Hospitalier Prive Saint-Gregoire
Department Name
Oncology
Principal Investigator Name
Xavier Artignan
Principal Investigator Email
sdurelpinson@vivalto-sante.com
Contact Person Name
Xavier Artignan
Contact Person Email
sdurelpinson@vivalto-sante.com
Site Name
Institut De Cancerologie De L Ouest (Saint-Herblain)
Department Name
Oncology
Principal Investigator Name
Stéphane Supiot
Principal Investigator Email
stephane.supiot@ico.unicancer.fr
Contact Person Name
Stéphane Supiot
Site Name
Hospital Foch
Department Name
Oncology
Principal Investigator Name
Thierry Lebret
Principal Investigator Email
t.lebret@hopital-foch.org
Contact Person Name
Thierry Lebret
Contact Person Email
t.lebret@hopital-foch.org
Site Name
Clinique Pasteur Lanroze
Department Name
Oncology
Principal Investigator Name
Ali Hasbini
Principal Investigator Email
alihasbini@oncologie-brest.fr
Contact Person Name
Ali Hasbini
Contact Person Email
alihasbini@oncologie-brest.fr
Site Name
Institut De Cancerologie De L Ouest (Angers)
Department Name
Oncology
Principal Investigator Name
Remy Delva
Principal Investigator Email
remy.delva@ico.unicancer.fr
Contact Person Name
Remy Delva
Contact Person Email
remy.delva@ico.unicancer.fr
Site Name
Unite De Recherche Clinique HIA Begin
Department Name
Oncology
Principal Investigator Name
Antoine Schernberg
Principal Investigator Email
aschernberg@gmail.com
Contact Person Name
Antoine Schernberg
Contact Person Email
aschernberg@gmail.com
Site Name
Institut Regional Du Cancer De Montpellier
Department Name
Oncology
Principal Investigator Name
David Azria
Principal Investigator Email
david.azria@icm.unicancer.fr
Contact Person Name
David Azria
Contact Person Email
david.azria@icm.unicancer.fr
Site Name
Centre Hospitalier Departemental Vendee
Department Name
Oncology
Principal Investigator Name
Frank Priou
Principal Investigator Email
frank.priou@chd-vendee.fr
Contact Person Name
Frank Priou
Contact Person Email
frank.priou@chd-vendee.fr
Site Name
Hopital Saint Louis
Department Name
Oncology
Principal Investigator Name
Christophe Hennequin
Principal Investigator Email
christophe.hennequin@sls.aphp.fr
Contact Person Name
Christophe Hennequin
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Surgery
Principal Investigator Name
Arnauld Villers
Principal Investigator Email
arnauld.villers@chru-lille.fr
Contact Person Name
Arnauld Villers
Contact Person Email
arnauld.villers@chru-lille.fr
Site Name
Institut De Cancerologie De L Ouest (other site)
Department Name
Oncology
Principal Investigator Name
Stéphane Supiot
Principal Investigator Email
stephane.supiot@ico.unicancer.fr
Contact Person Name
Stéphane Supiot

Netherlands

Latest Decision Or Authorization Date
23-07-2024
Number Of Sites
4
Number Of Participants
35

Sites

Site Name
Universitair Medisch Centrum Groningen
Department Name
Urology
Principal Investigator Name
Igle Jan de Jong
Principal Investigator Email
i.j.de.jong@uro.umcg.nl
Contact Person Name
Igle Jan de Jong
Contact Person Email
i.j.de.jong@uro.umcg.nl
Site Name
Academisch Ziekenhuis Maastricht
Department Name
Urology
Principal Investigator Name
Joep G.H. van Roermund
Principal Investigator Email
joep.van.roermund@mumc.nl
Contact Person Name
Joep G.H. van Roermund
Contact Person Email
joep.van.roermund@mumc.nl
Site Name
VUmc Stichting
Department Name
Urology
Principal Investigator Name
Reindert Van Moorselaar
Principal Investigator Email
rja.vanmoorselaar@amsterdamumc.nl
Contact Person Name
Reindert Van Moorselaar
Site Name
Catharina Ziekenhuis Stichting
Department Name
Urology
Principal Investigator Name
Evert Louwerens Koldewijn
Principal Investigator Email
evert.koldewijn@catharinaziekenhuis.nl
Contact Person Name
Evert Louwerens Koldewijn

Spain

Latest Decision Or Authorization Date
19-07-2024
Number Of Sites
13
Number Of Participants
74

Sites

Site Name
Fundacion Instituto Valenciano De Oncologia
Department Name
Servicio de Urología
Principal Investigator Name
Gomez Ferrer Alvaro
Principal Investigator Email
agomezferrer@fivo.org
Contact Person Name
Gomez Ferrer Alvaro
Contact Person Email
agomezferrer@fivo.org
Site Name
Hospital Universitario 12 De Octubre
Department Name
Servicio de Urologia
Principal Investigator Name
Alfredo Rodriguez Antolin
Principal Investigator Email
arantolin@yahoo.es
Contact Person Name
Ola Alfredo Rodriguez Antolin
Contact Person Email
arantolin@yahoo.es
Site Name
University Hospital Son Espases
Department Name
Servicio de Oncologia Medica-Carretera
Principal Investigator Name
Maria del Carmen Garcias de Espana
Principal Investigator Email
mariad.garcias@ssib.es
Contact Person Name
Maria del Carmen Garcias de Espana
Contact Person Email
mariad.garcias@ssib.es
Site Name
Hospital Universitario De Salamanca
Department Name
Servicio de Urologia
Principal Investigator Name
Manuel Herrero Polo
Principal Investigator Email
mherreropolo@gmail.com
Contact Person Name
Manuel Herrero Polo
Contact Person Email
mherreropolo@gmail.com
Site Name
Hospital Universitari De Girona Doctor Josep Trueta
Department Name
Servicio de Oncologia
Principal Investigator Name
Alvar Rosello Serrano
Principal Investigator Email
arosello@iconcologia.net
Contact Person Name
Alvar Rosello Serrano
Contact Person Email
arosello@iconcologia.net
Site Name
MD Anderson Cancer Center (Madrid)
Department Name
Servicio de Oncologia
Principal Investigator Name
Jose Angel Arranz Arija
Principal Investigator Email
jarranza.oncomed@gmail.com
Contact Person Name
Jose Angel Arranz Arija
Contact Person Email
jarranza.oncomed@gmail.com
Site Name
Hospital Del Mar
Department Name
Servicio de Urologia
Principal Investigator Name
Lluis Cecchini Rosell
Principal Investigator Email
lcecchini@psmar.cat
Contact Person Name
Lluis Cecchini Rosell
Contact Person Email
lcecchini@psmar.cat
Site Name
Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada
Department Name
Servicio Oncologia Medica
Principal Investigator Name
Montserrat Domenech Santasusana
Principal Investigator Email
mdomenech@althaia.cat
Contact Person Name
Montserrat Domenech Santasusana
Contact Person Email
mdomenech@althaia.cat
Site Name
Parc Tauli Hospital Universitari
Department Name
Servicio de Urologia
Principal Investigator Name
Jesus Munoz Rodriguez
Principal Investigator Email
JMunozr@tauli.cat
Contact Person Name
Jesus Munoz Rodriguez
Contact Person Email
JMunozr@tauli.cat
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Servicio de Urología
Principal Investigator Name
Francisco Javier Burgos Revilla
Principal Investigator Email
burgosrevillajavier@gmail.com
Contact Person Name
Francisco Javier Burgos Revilla
Contact Person Email
burgosrevillajavier@gmail.com
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Servicio de Oncologia
Principal Investigator Name
Carlos Hernandez Fernandez
Principal Investigator Email
carloshfdez@telefonica.net
Contact Person Name
Carlos Hernandez Fernandez
Contact Person Email
carloshfdez@telefonica.net
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Servicio de Oncologia
Principal Investigator Name
Ana Maria Carballo Castro
Principal Investigator Email
ana.maria.carballo.castro@sergas.es
Contact Person Name
Ana Maria Carballo Castro
Site Name
Hospital Universitario De La Princesa
Department Name
Urology
Principal Investigator Name
Luis Alberto San José Manso
Principal Investigator Email
Lsanjose.hcsc@salud.madrid.org
Contact Person Name
Luis Alberto San José Manso
Contact Person Email
Lsanjose.hcsc@salud.madrid.org

Finland

Latest Decision Or Authorization Date
19-07-2024
Number Of Sites
5
Number Of Participants
57

Sites

Site Name
Etelae-Pohjanmaan hyvinvointialue
Department Name
Urology
Principal Investigator Name
Timo Marttila
Principal Investigator Email
Timo.Marttila@hyvaep.fi
Contact Person Name
Timo Marttila
Contact Person Email
Timo.Marttila@hyvaep.fi
Site Name
Satakunnan hyvinvointialue
Department Name
Urology
Principal Investigator Name
Teemu Joutsi
Principal Investigator Email
teemu.joutsi@sata.fi
Contact Person Name
Teemu Joutsi
Contact Person Email
teemu.joutsi@sata.fi
Site Name
HUS-Yhtymae
Department Name
Urology
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
Urology
Principal Investigator Name
Hanna Ronkainen
Principal Investigator Email
hanna.ronkainen@ppshp.fi
Contact Person Name
Hanna Ronkainen
Contact Person Email
hanna.ronkainen@ppshp.fi
Site Name
Tampere University Hospital
Department Name
Urology
Principal Investigator Name
Teuvo Tammela
Principal Investigator Email
teuvo.tammela@pirha.fi
Contact Person Name
Teuvo Tammela
Contact Person Email
teuvo.tammela@pirha.fi

Sponsor

Primary sponsor

Full Name
Medivation Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
IQVIA Limited
Name
Signant Health Global LLC
Responsibilities
treatment randomisation

Third parties

  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"treatment randomisation","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Xtandi - 40 mg soft capsules
Active Substance
ENZALUTAMIDE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
oral
Authorisation Status
Authorised (EU marketing authorisation EU/1/13/846/001)
Maximum Dose
160 mg
Investigational Product Name
LEUPRORELIN ACETATE
Active Substance
LEUPRORELIN ACETATE
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS USE
Route
subcutaneous
Authorisation Status
Authorised (SUB02900MIG)
Maximum Dose
22.5 mg
Investigational Product Name
Placebo for Enzalutamide 40 mg soft gelatin capsule
Modality
Other
Combination Treatment
Yes

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