Clinical trial • Phase II • Oncology

Enzalutamide for Prostate cancer | Metastatic prostate cancer

Phase II trial of Enzalutamide for Prostate cancer | Metastatic prostate cancer. open-label. 392 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Prostate cancer | Metastatic prostate cancer
Trial Stage
Phase II
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
04-03-2024
First CTIS Authorization Date
09-04-2024

Trial design

open-label Phase II trial in Netherlands, Belgium, Czechia and others.

Open Label
Yes
Target Sample Size
392
Trial Duration For Participant
1095

Eligibility

Recruits 392 No vulnerable populations selected. Adult male subjects only (patients with prostate cancer). IRB/IEC-approved written informed consent and privacy language must be obtained from each subject prior to any study-related procedures. (HIPAA authorisation referenced for US sites.).

Pregnancy Exclusion
Subject and his female partner who is of childbearing potential must continue to use 2 forms of birth control, of which 1 must be highly effective† and 1 must be a barrier method‡ throughout the study and for 3 months after final enzalutamide administration. Two acceptable forms of birth control include: ‡ Condom (barrier method of contraception), AND † In addition to a condom, 1 of the following acceptable forms of contraception is required: ● Established use of oral, injected or implanted hormonal methods of contraception ● Placement of an intrauterine device or intrauterine system ● Tubal ligation ● Vasectomy or other surgical castration prior to initial screening
Vulnerable Population
No vulnerable populations selected. Adult male subjects only (patients with prostate cancer). IRB/IEC-approved written informed consent and privacy language must be obtained from each subject prior to any study-related procedures. (HIPAA authorisation referenced for US sites.)

Inclusion criteria

  • {"criterion_text":"- IRB/IEC approved written Informed Consent and privacy language as per national regulations [e.g., Health Insurance Portability and Accountability Act authorization for the United States sites] must be obtained from the subject prior to any study-related procedures."}
  • {"criterion_text":"- Subject must currently be receiving enzalutamide for prostate cancer in a study sponsored by Astellas or Medivation/Pfizer and based on the investigator’s assessment, benefit from continued treatment. Subjects participating in investigator-initiated trials are not eligible."}
  • {"criterion_text":"- Subjects are able to continue on the treatment regimen that they were receiving in the prior study. If in the investigator’s assessment a change is needed to the subject’s regimen approval (e.g., dose change in androgen deprivation therapy (ADT) or dropping of a combination therapy) approval from a medical monitor is required prior to enrollment."}
  • {"criterion_text":"- Subject is able to swallow enzalutamide capsules and comply with study requirements."}
  • {"criterion_text":"- Subject and his female partner who is of childbearing potential must continue to use 2 forms of birth control, of which 1 must be highly effective† and 1 must be a barrier method‡ throughout the study and for 3 months after final enzalutamide administration. Two acceptable forms of birth control include: ‡ Condom (barrier method of contraception), AND † In addition to a condom, 1 of the following acceptable forms of contraception is required: ● Established use of oral, injected or implanted hormonal methods of contraception ● Placement of an intrauterine device or intrauterine system ● Tubal ligation ● Vasectomy or other surgical castration prior to initial screening"}
  • {"criterion_text":"- Subject agrees to avoid sperm donation during the study and for at least 3 months after final enzalutamide administration."}

Exclusion criteria

  • {"criterion_text":"- Subject met any of the discontinuation criteria or whose cancer progressed on the current enzalutamide clinical study in which they are enrolling from."}
  • {"criterion_text":"- Subject requires treatment with or plans to use any of the following: ● New systemic therapy for their cancer (palliative radiation therapy is allowed). The treatment with agents administered during previous studies which was stopped and then restarted during this study does not represent new treatment (e.g., ADT). ● Investigational therapy other than enzalutamide."}
  • {"criterion_text":"- Subject is currently participating in an investigator-initiated interventional trial and receiving enzalutamide."}
  • {"criterion_text":"- Subject has any concurrent disease, infection, or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data in the opinion of the investigator."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Not Applicable","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
392
Recruitment Window Months
132
Consent Approach
Written IRB/IEC‑approved informed consent and privacy language must be obtained from each subject prior to any study-related procedures. Consent is provided by the adult subject (no assent procedures described). ICF materials and related documents are available in multiple languages (documents and protocol synopses provided in English and translated versions including French, Dutch, Spanish, German, Polish, Slovak, Italian, Swedish, Norwegian, Czech, Romanian as indicated in the submission).

Methods

  • Recruitment by roll-over from parent enzalutamide clinical studies sponsored by Astellas or Medivation/Pfizer: subjects currently receiving enzalutamide in a qualifying parent study and judged by the investigator to continue to benefit are eligible to continue in this open-label extension.

Geography

Total Number Of Sites
63
Total Number Of Participants
251

Netherlands

Earliest CTIS Part Ii Submission Date
29-03-2024
Latest Decision Or Authorization Date
09-04-2024
Processing Time Days
11
Number Of Sites
4
Number Of Participants
12

Sites

Site Name
Noordwest Ziekenhuisgroep Stichting
Department Name
Polikliniek Urologie
Principal Investigator Name
Ton Roeleveld
Principal Investigator Email
t.a.roeleveld@nwz.nl
Contact Person Name
Ton Roeleveld
Contact Person Email
t.a.roeleveld@nwz.nl
Site Name
University Hospital Maastricht
Department Name
Urology
Principal Investigator Name
Joep Van Roermund
Principal Investigator Email
Joep.van.roermund@mumc.nl
Contact Person Name
Joep Van Roermund
Contact Person Email
Joep.van.roermund@mumc.nl
Site Name
Sint Franciscus Vlietland Groep Stichting
Department Name
Departement of Oncology
Principal Investigator Name
Aart-Paul Hamberg
Principal Investigator Email
researchinterne@franciscus.nl
Contact Person Name
Aart-Paul Hamberg
Contact Person Email
researchinterne@franciscus.nl
Site Name
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Department Name
Urology
Principal Investigator Name
Henk Van der Poel
Principal Investigator Email
h.vd.poel@nki.nl
Contact Person Name
Henk Van der Poel
Contact Person Email
h.vd.poel@nki.nl

Belgium

Earliest CTIS Part Ii Submission Date
29-03-2024
Latest Decision Or Authorization Date
18-04-2024
Processing Time Days
20
Number Of Sites
4
Number Of Participants
19

Sites

Site Name
Az Maria Middelares Gent
Department Name
Urology
Principal Investigator Name
Filip Ameye
Principal Investigator Email
Filip.Ameye@mijnziekenhuis.be
Contact Person Name
Filip Ameye
Contact Person Email
Filip.Ameye@mijnziekenhuis.be
Site Name
Vrije Universiteit Brussel
Department Name
Consultation Urology
Principal Investigator Name
Dirk Michielsen
Principal Investigator Email
dirk.michielsen@uzbrussel.be
Contact Person Name
Dirk Michielsen
Contact Person Email
dirk.michielsen@uzbrussel.be
Site Name
Algemeen Ziekenhuis Groeninge
Department Name
Urology
Principal Investigator Name
Patrick Werbrouck
Principal Investigator Email
patrick.werbrouck@azgroeninge.be
Contact Person Name
Patrick Werbrouck
Site Name
Hopital Erasme
Department Name
Urology
Principal Investigator Name
Thierry Roumeguère
Principal Investigator Email
SecMed.Uro.erasme@hubruxelles.be
Contact Person Name
Thierry Roumeguère

Czechia

Earliest CTIS Part Ii Submission Date
29-03-2024
Latest Decision Or Authorization Date
10-04-2024
Processing Time Days
12
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Uromedical Center s.r.o.
Department Name
Urology
Principal Investigator Name
Vladimir Student
Principal Investigator Email
studentv@seznam.cz
Contact Person Name
Vladimir Student
Contact Person Email
studentv@seznam.cz
Site Name
Androgeos spol. s r.o.
Department Name
Urologie
Principal Investigator Name
Jiri Heracek
Principal Investigator Email
heracek@androgeos.cz
Contact Person Name
Jiri Heracek
Contact Person Email
heracek@androgeos.cz
Site Name
University Hospital Olomouc
Department Name
Oncology Department
Principal Investigator Name
Bohuslav Melichar
Principal Investigator Email
Bohuslav.Melichar@fnol.cz
Contact Person Name
Bohuslav Melichar
Contact Person Email
Bohuslav.Melichar@fnol.cz

Sweden

Earliest CTIS Part Ii Submission Date
29-03-2024
Latest Decision Or Authorization Date
10-04-2024
Processing Time Days
12
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
Department of Urology
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
Norrlands University Hospital
Department Name
Dept of urology
Principal Investigator Name
Borje Ljungberg
Principal Investigator Email
Borje.ljungberg@umu.se
Contact Person Name
Borje Ljungberg
Contact Person Email
Borje.ljungberg@umu.se

Austria

Earliest CTIS Part Ii Submission Date
29-03-2024
Latest Decision Or Authorization Date
15-04-2024
Processing Time Days
17
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Medical University Of Vienna
Department Name
Department of Medicine I, Division of Oncology
Principal Investigator Name
Michael Krainer
Principal Investigator Email
michael.krainer@meduniwien.ac.at
Contact Person Name
Michael Krainer

Italy

Earliest CTIS Part Ii Submission Date
29-03-2024
Latest Decision Or Authorization Date
11-04-2024
Processing Time Days
13
Number Of Sites
6
Number Of Participants
24

Sites

Site Name
Azienda Provinciale Per I Servizi Sanitari
Department Name
Oncology Unit
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
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Oncology department
Principal Investigator Name
Nicole Brighi
Principal Investigator Email
Nicole.brighi@irst.emr.it
Contact Person Name
Nicole Brighi
Contact Person Email
Nicole.brighi@irst.emr.it
Site Name
Azienda Socio Sanitaria Territoriale Di Cremona
Department Name
Oncology
Principal Investigator Name
Maddalena Donini
Principal Investigator Email
maddalena.donini@asst-cremona.it
Contact Person Name
Maddalena Donini
Site Name
Universita' Di Pisa
Department Name
U.O. Oncologia Medica II
Principal Investigator Name
Luca Galli
Principal Investigator Email
aiutopoint@ao-pisa.toscana.it
Contact Person Name
Luca Galli
Contact Person Email
aiutopoint@ao-pisa.toscana.it
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
Unità Operativa di Oncologia
Principal Investigator Name
Francesco Carrozza
Principal Investigator Email
francesco.carrozza@auslromagna.it
Contact Person Name
Francesco Carrozza
Site Name
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS
Department Name
Oncology
Principal Investigator Name
Alessandra Mosca
Principal Investigator Email
social@ircc.it
Contact Person Name
Alessandra Mosca
Contact Person Email
social@ircc.it

Germany

Earliest CTIS Part Ii Submission Date
29-03-2024
Latest Decision Or Authorization Date
10-04-2024
Processing Time Days
12
Number Of Sites
3
Number Of Participants
14

Sites

Site Name
Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR
Department Name
Studienpraxis Urologie
Principal Investigator Name
Tilman Todenhöfer
Principal Investigator Email
praxis@studienurologie.de
Contact Person Name
Tilman Todenhöfer
Contact Person Email
praxis@studienurologie.de
Site Name
Universitat Heidelberg
Department Name
Medizinische Fakultät Mannheim, Klinik für Urologie und Urochirurgie
Principal Investigator Name
Frederik Wessels
Principal Investigator Email
Frederik.wessels@medma.uni-heidelberg.de
Contact Person Name
Frederik Wessels
Site Name
Urologikum Hamburg MVZ
Department Name
Urologie
Principal Investigator Name
Volker Heinemann
Principal Investigator Email
hammoniabad@urologikum-hamburg.de
Contact Person Name
Volker Heinemann

Slovakia

Earliest CTIS Part Ii Submission Date
29-03-2024
Latest Decision Or Authorization Date
09-04-2024
Processing Time Days
11
Number Of Sites
7
Number Of Participants
28

Sites

Site Name
Milab s.r.o.
Department Name
Urocentrum
Principal Investigator Name
Ivan Mincik
Principal Investigator Email
maria.mincikove@gmail.com
Contact Person Name
Ivan Mincik
Contact Person Email
maria.mincikove@gmail.com
Site Name
Privatna Urologicka Ambulancia s.r.o.
Department Name
Urology
Principal Investigator Name
Roman Sokol
Principal Investigator Email
roman.sokol@urology.sk
Contact Person Name
Roman Mich Nielsen
Contact Person Email
roman.sokol@urology.sk
Site Name
Cuimed s.r.o.
Department Name
Urologicka ambulancia
Principal Investigator Name
Frederico Goncalves
Principal Investigator Email
goncalves@chello.sk
Contact Person Name
Frederico Goncalves
Contact Person Email
goncalves@chello.sk
Site Name
Vychodoslovensky Onkologicky Ustav a.s.
Department Name
Department of Radiation Oncology
Principal Investigator Name
Pavol Dubinsky
Principal Investigator Email
dubinsky@vou.sk
Contact Person Name
Pavol Dubinsky
Contact Person Email
dubinsky@vou.sk
Site Name
Fakultna Nemocnica S Poliklinikou Zilina
Department Name
Urologic Dept.
Principal Investigator Name
Juraj Mikulas
Principal Investigator Email
mikuljur50@gmail.com
Contact Person Name
Juraj Mikulas
Contact Person Email
mikuljur50@gmail.com
Site Name
Zeleznicne zdravotnictvo Kosice s.r.o.
Department Name
Urologicka ambulancia
Principal Investigator Name
Marek Vargovcak
Principal Investigator Email
m.vargovcak@gmail.com
Contact Person Name
Marek Vargovcak
Contact Person Email
m.vargovcak@gmail.com
Site Name
Uroexam spol. s r.o.
Department Name
Urology
Principal Investigator Name
Jozef Marko
Principal Investigator Email
urologmarko@yahoo.com
Contact Person Name
Jozef Marko
Contact Person Email
urologmarko@yahoo.com

Romania

Earliest CTIS Part Ii Submission Date
29-03-2024
Latest Decision Or Authorization Date
16-04-2024
Processing Time Days
18
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Radiotherapy I
Principal Investigator Name
Cristina Ligia Cebotaru
Principal Investigator Email
cristinacebotaru@yahoo.com
Contact Person Name
Cristina Ligia Cebotaru
Contact Person Email
cristinacebotaru@yahoo.com
Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Medical Oncology I
Principal Investigator Name
Tudor Ciuleanu
Principal Investigator Email
tudor@iocn.ro
Contact Person Name
Tudor Ciuleanu
Contact Person Email
tudor@iocn.ro
Site Name
Spitalul Clinic Prof.Dr.Theodor Burghele
Department Name
Urology III
Principal Investigator Name
Viorel Jinga
Principal Investigator Email
vioreljinga@yahoo.com
Contact Person Name
Viorel Jinga
Contact Person Email
vioreljinga@yahoo.com

Finland

Earliest CTIS Part Ii Submission Date
29-03-2024
Latest Decision Or Authorization Date
10-04-2024
Processing Time Days
12
Number Of Sites
2
Number Of Participants
14

Sites

Site Name
Varsinais-Suomen hyvinvointialue
Department Name
Department of Urology
Principal Investigator Name
Peter Joakin Boström
Principal Investigator Email
Peter.bostrom@tyks.fi
Contact Person Name
Peter Joakin Boström
Contact Person Email
Peter.bostrom@tyks.fi
Site Name
Tampere University Hospital
Department Name
URP1
Principal Investigator Name
Teuvo Tammela
Principal Investigator Email
teuvo.tammela@tuni.fi
Contact Person Name
Teuvo Tammela
Contact Person Email
teuvo.tammela@tuni.fi

Norway

Earliest CTIS Part Ii Submission Date
29-03-2024
Latest Decision Or Authorization Date
11-04-2024
Processing Time Days
13
Number Of Sites
1
Number Of Participants
1

Sites

Site Name
Helse Stavanger HF
Department Name
Avdeling for blod- og kreftsykdommer - FOU
Principal Investigator Name
Bjornar Gilje
Principal Investigator Email
bjornar.gilje@sus.no
Contact Person Name
Bjornar Gilje
Contact Person Email
bjornar.gilje@sus.no

Denmark

Earliest CTIS Part Ii Submission Date
29-03-2024
Latest Decision Or Authorization Date
10-04-2024
Processing Time Days
12
Number Of Sites
5
Number Of Participants
56

Sites

Site Name
Aarhus Universitetshospital
Department Name
Department of 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
Site Name
Lillebaelt Hospital
Department Name
Urological Research Center
Principal Investigator Name
Bettina Noerby
Principal Investigator Email
Bettina.Noerby@rsyd.dk
Contact Person Name
Bettina Noerby
Contact Person Email
Bettina.Noerby@rsyd.dk
Site Name
Aalborg University Hospital
Department Name
Urologisk afdeling Afsnit Nord
Principal Investigator Name
Anne Buchhave Olsen
Principal Investigator Email
anbo@rn.dk
Contact Person Name
Anne Buchhave Olsen
Contact Person Email
anbo@rn.dk
Site Name
Region Hovedstaden
Department Name
Urological Research Department, Department of Urology
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
Rigshospitalet
Department Name
Copenhagen Prostate cancer center
Principal Investigator Name
Klaus Brasso
Principal Investigator Email
Klaus.Brasso@regionh.dk
Contact Person Name
Klaus Brasso
Contact Person Email
Klaus.Brasso@regionh.dk

Spain

Earliest CTIS Part Ii Submission Date
29-03-2024
Latest Decision Or Authorization Date
12-04-2024
Processing Time Days
14
Number Of Sites
9
Number Of Participants
20

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Principal Investigator Name
Joaquin Mateo Valderrama
Principal Investigator Email
jmateo@vhio.net
Contact Person Name
Joaquin Mateo Valderrama
Contact Person Email
jmateo@vhio.net
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Servicio de Oncología Radioterápica
Principal Investigator Name
Ana Maria Carballo Gomez
Principal Investigator Email
ana.maria.carnallo.castro@sergas.es
Contact Person Name
Ana Maria Carballo Gomez
Site Name
Parc Tauli Hospital Universitari
Department Name
Oncology
Principal Investigator Name
Enrique Gallardo
Principal Investigator Email
egallardo@tauli.cat
Contact Person Name
Enrique Gallardo
Contact Person Email
egallardo@tauli.cat
Site Name
Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada
Department Name
Oncology
Principal Investigator Name
Montserrat Domenech
Principal Investigator Email
mdomenech@althaia.cat
Contact Person Name
Montserrat Domenech
Contact Person Email
mdomenech@althaia.cat
Site Name
MD Anderson Cancer Center
Department Name
Oncology
Principal Investigator Name
Fernando Fabio Franco Perez
Principal Investigator Email
ffranco@funacionmdanderson.es
Contact Person Name
Fernando Fabio Franco Perez
Contact Person Email
ffranco@funacionmdanderson.es
Site Name
Institut Catala D'oncologia
Department Name
Oncology Medical
Principal Investigator Name
Núria Sala
Principal Investigator Email
nsgonzalez@iconcologia.net
Contact Person Name
Núria Sala
Contact Person Email
nsgonzalez@iconcologia.net
Site Name
Hospital Clinic De Barcelona
Department Name
Urology Service
Principal Investigator Name
Antonio Alcaraz
Principal Investigator Email
aalcaraz@clinic.cat
Contact Person Name
Antonio Alcaraz
Contact Person Email
aalcaraz@clinic.cat
Site Name
Hospital Universitario De Salamanca
Department Name
Urology Service
Principal Investigator Name
Manuel Herrero Polo
Principal Investigator Email
mherrerop@saludcastillayleon.es
Contact Person Name
Manuel Herrero Polo
Site Name
Parc Tauli Hospital Universitari (additional site listed)
Department Name
Oncology (duplicate entry present in file)
Principal Investigator Name
Enrique Gallardo
Principal Investigator Email
egallardo@tauli.cat
Contact Person Name
Enrique Gallardo
Contact Person Email
egallardo@tauli.cat

France

Earliest CTIS Part Ii Submission Date
29-03-2024
Latest Decision Or Authorization Date
12-04-2024
Processing Time Days
14
Number Of Sites
8
Number Of Participants
20

Sites

Site Name
Groupe Hospitalier Saint Vincent
Department Name
Oncology
Principal Investigator Name
Youssef Tazi
Principal Investigator Email
ytazi@solcrr.org
Contact Person Name
Youssef Tazi
Contact Person Email
ytazi@solcrr.org
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Institut de cancérologie Strasbourg Europe
Principal Investigator Name
Philippe Barthelemy
Principal Investigator Email
p.barthelemy@icans.eu
Contact Person Name
Philippe Barthelemy
Contact Person Email
p.barthelemy@icans.eu
Site Name
Hospices Civils De Lyon
Department Name
Service Urologie et chirurgie de la transplantation
Principal Investigator Name
Marc Colombel
Principal Investigator Email
marc.colombel@chu-lyon.fr
Contact Person Name
Marc Colombel
Contact Person Email
marc.colombel@chu-lyon.fr
Site Name
Centre Hospitalier Departemental Vendee
Department Name
Onco-hematology
Principal Investigator Name
Frank Priou
Contact Person Name
Frank Priou
Site Name
Institut Bergonie
Department Name
Medical oncology
Principal Investigator Name
Guilhem Roubaud
Principal Investigator Email
g.roubaud@bordeaux.unicancer.fr
Contact Person Name
Guilhem Roubaud
Site Name
Institut Gustave Roussy
Department Name
Oncology
Principal Investigator Name
Ronan Flippot
Principal Investigator Email
Ronan.flippot@gustaveroussy.fr
Contact Person Name
Flippot Ronan
Contact Person Email
Ronan.flippot@gustaveroussy.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Medical oncology
Principal Investigator Name
Loic Jaffrelot
Principal Investigator Email
Loic.jaffrelot@aphp.fr
Contact Person Name
Loic Jaffrelot
Contact Person Email
Loic.jaffrelot@aphp.fr
Site Name
Institut Regional Du Cancer De Montpellier
Department Name
Radiotherapy
Principal Investigator Name
David Azria
Principal Investigator Email
David.azria@icm.inicancer.fr
Contact Person Name
David Azria
Contact Person Email
David.azria@icm.inicancer.fr

Poland

Earliest CTIS Part Ii Submission Date
29-03-2024
Latest Decision Or Authorization Date
12-04-2024
Processing Time Days
14
Number Of Sites
5
Number Of Participants
16

Sites

Site Name
Szpital Grochowski Im.Dr Med. Rafała Masztaka Sp. z o.o.
Department Name
Oncology
Principal Investigator Name
Iwona Skoneczna
Principal Investigator Email
iskoneczna@grochowski.waw.pl
Contact Person Name
Iwona Skoneczna
Contact Person Email
iskoneczna@grochowski.waw.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
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o.
Department Name
Oddział Urologiczny
Principal Investigator Name
Jacek Ołubiec
Principal Investigator Email
urologia@szpitall.slupsk.pl
Contact Person Name
Jacek Ołubiec
Contact Person Email
urologia@szpitall.slupsk.pl
Site Name
Penta Hospitals Przychodnie
Department Name
Urology
Principal Investigator Name
Rafal Kmieciak
Principal Investigator Email
raf.kmieciak@gmail.com
Contact Person Name
Rafal Kmieciak
Contact Person Email
raf.kmieciak@gmail.com
Site Name
Centrum Urologiczne Sp. z o.o.
Department Name
Urology
Principal Investigator Name
Adam Dobrowolski
Principal Investigator Email
adobrowolski@urocentrum.pl
Contact Person Name
Adam Dobrowolski
Contact Person Email
adobrowolski@urocentrum.pl

Sponsor

Primary sponsor

Full Name
Astellas Pharma Global Development Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Fisher Clinical Services GmbH
Responsibilities
sponsorDuties codes: 14
Name
Parexel International Corp.
Responsibilities
sponsorDuties codes: 6
Name
Signant Health Global LLC
Responsibilities
sponsorDuties codes: 3
Name
Icon Clinical Research Limited
Responsibilities
sponsorDuties codes: 1,12,13,8
Name
Almac Clinical Services LLC
Responsibilities
sponsorDuties codes: 14
Name
Medidata Solutions Inc.
Responsibilities
sponsorDuties codes: 7

Third parties

  • {"country":"Switzerland","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"sponsorDuties codes: 14","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"sponsorDuties codes: 6","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"sponsorDuties codes: 3","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: 1,12,13,8","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Almac Clinical Services LLC","duties_or_roles":"sponsorDuties codes: 14","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: 7","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
MDV3100
Active Substance
Enzalutamide
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Authorised product (product PRD267627 listed)
Starting Dose
160 mg
Dose Levels
160 mg
Frequency
Once daily
Maximum Dose
160 mg daily
Investigational Product Name
Abiraterone
Active Substance
Abiraterone
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Auxiliary medicinal product (authorized in relevant Member States)
Starting Dose
1000 mg
Dose Levels
1000 mg
Frequency
Once daily (QD)
Maximum Dose
1000 mg daily
Investigational Product Name
Prednisone (Prednisolone listed as active substance PREDNISOLONE)
Active Substance
Prednisolone
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Auxiliary medicinal product (authorized in relevant Member States)
Starting Dose
5 mg twice daily (5 mg BID)
Dose Levels
5 mg BID (total 10 mg/day)
Frequency
Twice daily (BID)
Maximum Dose
10 mg daily
Combination Treatment
Yes

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