Clinical trial • Phase III • Oncology

Enzalutamide for Metastatic castration-sensitive prostate cancer

Phase III trial of Enzalutamide for Metastatic castration-sensitive prostate cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Metastatic castration-sensitive prostate cancer
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
30-04-2024
First CTIS Authorization Date
10-06-2024

Trial design

Randomised, two arms: talazoparib in combination with enzalutamide versus placebo in combination with enzalutamide. product information in part i lists enzalutamide (xtandi - 40 mg soft capsules, max daily dose amount 160 mg) and talazoparib (talazoparib, max daily dose amount 0.5 mg). specific dosing schedules in the protocol text are not provided in the available ctis metadata.-controlled Phase III trial in Hungary, Slovakia, Finland and others.

Randomised
Yes
Comparator
Two arms: Talazoparib in combination with enzalutamide versus Placebo in combination with enzalutamide. Product information in Part I lists enzalutamide (Xtandi - 40 mg soft capsules, max daily dose amount 160 mg) and talazoparib (TALAZOPARIB, max daily dose amount 0.5 mg). Specific dosing schedules in the protocol text are not provided in the available CTIS metadata.
Biomarker Stratified
True, DDR gene mutation status (HRR deficiencies)
Target Sample Size
344

Eligibility

Recruits 344 No vulnerable population selected (isVulnerablePopulationSelected: false). Participants are adult males with metastatic castration-sensitive prostate cancer. Informed consent is required from participants; subject information and informed consent forms (ICDs/ICFs) are provided and available in multiple country/language versions (examples in the public documents: HU, SK, FI, IT, DE, NL, BE (EN/FR/NL), FR, ES, BG, CZ, NO, EN)..

Vulnerable Population
No vulnerable population selected (isVulnerablePopulationSelected: false). Participants are adult males with metastatic castration-sensitive prostate cancer. Informed consent is required from participants; subject information and informed consent forms (ICDs/ICFs) are provided and available in multiple country/language versions (examples in the public documents: HU, SK, FI, IT, DE, NL, BE (EN/FR/NL), FR, ES, BG, CZ, NO, EN).

Inclusion criteria

  • {"criterion_text":"- 1. Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, small cell or signet cell features"}
  • {"criterion_text":"- 2. Confirmation of DDR gene mutation status by prospective or historical analysis (with sponsor pre-approval) of blood (liquid biopsy) and/or de novo or archival tumor tissue using FoundationOne® Liquid CDx or FoundationOne® CDx"}
  • {"criterion_text":"- 3. Ongoing ADT with a gonadotropin-releasing hormone (GnRH) agonist or antagonist for participants who have not undergone bilateral orchiectomy must be initiated before randomization and must continue throughout the study"}
  • {"criterion_text":"- 4. Metastatic prostate cancer documented by positive bone scan (for bone disease) or metastatic lesions on CT or MRI scan (for soft tissue). Participants whose disease spread is limited to regional pelvic lymph nodes are not eligible. Note: a finding of superscan at baseline is exclusionary"}
  • {"criterion_text":"- 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1."}

Exclusion criteria

  • {"criterion_text":"- 1. Other acute or chronic medical [concurrent disease, infection, including chronic stable Human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection, or co-morbidity] or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that interferes with a participant’s ability to participate in the study, may increase the risk associated with study participation or study treatment administration, or may interfere with the interpretation of study results, and, in the investigator’s judgment, make the participant inappropriate for entry into the study. HIV/HBV/HCV testing is not required unless mandated by local health authority."}
  • {"criterion_text":"- 2. History of seizure or any condition (as assessed by investigator) that may predispose to seizure"}
  • {"criterion_text":"- 3. Known or suspected brain metastasis or active leptomeningeal disease."}
  • {"criterion_text":"- 4. Clinically significant cardiovascular disease."}
  • {"criterion_text":"- 5. Prior treatment in any setting with NHT except prior ADT in the adjuvant/neoadjuvant setting, where the completion of ADT was less than 12 months prior to randomization and the total duration of ADT exceeded 36 months."}
  • {"criterion_text":"- 6. Any previous treatment with DNA-damaging cytotoxic chemotherapy (ie, platinum based therapy) within 5 years prior to randomization, except for indications other than prostate cancer."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Investigator-assessed rPFS per Response Evaluation Criteria in Solid Tumors (RECIST 1.1 [soft tissue disease]) and Prostate Cancer Working Group (PCWG3 [bone disease]) in participants with mCSPC harboring HRR deficiencies.","definition_or_measurement_approach":"Investigator-assessed radiographic progression-free survival (rPFS) measured per RECIST 1.1 for soft tissue disease and PCWG3 for bone disease in participants with mCSPC harboring HRR deficiencies."}

Secondary endpoints

  • {"endpoint_text":"- OS in participants with mCSPC harboring HRR deficiencies (alpha protected).","definition_or_measurement_approach":"Overall survival (OS) in participants with mCSPC harboring HRR deficiencies; noted as 'alpha protected' in the protocol."}

Recruitment

Planned Sample Size
344
Recruitment Window Months
39
Consent Approach
Informed consent is required from participating adult subjects (no assent). Subject information and informed consent forms (ICDs/ICFs) are provided in multiple country/language versions as per public documents (examples include HU, SK, FI, IT, DE, NL, BE (EN/FR/NL), FR, ES, BG, CZ, NO, EN). The CTIS record includes subject information and informed consent form documents for each Member State/publication version.

Geography

Total Number Of Sites
69
Total Number Of Participants
207

Hungary

Earliest CTIS Part Ii Submission Date
17-05-2024
Latest Decision Or Authorization Date
10-06-2024
Processing Time Days
24
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Jahn Ferenc Del-Pesti Korhaz Es Rendelointezet
Department Name
Urologiai Osztaly
Contact Person Name
Peter Tenke
Contact Person Email
tenke.peter@jahndelpest.hu
Site Name
Orszagos Onkologiai Intezet
Department Name
Urogenitális Tumorok és Klinikai Farmakológiai Osztály
Contact Person Name
Lajos Geczi
Contact Person Email
gelajos@oncol.hu

Slovakia

Earliest CTIS Part Ii Submission Date
17-05-2024
Latest Decision Or Authorization Date
10-06-2024
Processing Time Days
24
Number Of Sites
4
Number Of Participants
9

Sites

Site Name
Narodny Onkologicky Ustav
Department Name
Oddelenie klinickej onkologie D
Contact Person Name
Michal Mego
Contact Person Email
Michal.Mego@nou.sk
Site Name
Privatna Urologicka Ambulancia s.r.o.
Contact Person Name
Roman Sokol
Contact Person Email
roman.sokol@urology.sk
Site Name
Milab s.r.o.
Department Name
Urologicka Ambulancia
Contact Person Name
Ivan Mincik
Contact Person Email
mincik.ivan@gmail.com
Site Name
Vychodoslovensky Onkologicky Ustav a.s.
Department Name
Oddelenie radiacnej onkologie
Contact Person Name
Pavol Dubinsky
Contact Person Email
dubinsky@vou.sk

Finland

Earliest CTIS Part Ii Submission Date
17-05-2024
Latest Decision Or Authorization Date
10-06-2024
Processing Time Days
24
Number Of Sites
2
Number Of Participants
11

Sites

Site Name
University Of Helsinki
Department Name
Department of Urology
Contact Person Name
Antti Rannikko
Contact Person Email
antti.rannikko@hus.fi
Site Name
Turku University Hospital
Department Name
Department of Urology
Contact Person Name
Peter Joakim Bostrom
Contact Person Email
peter.bostrom@varha.fi

Italy

Earliest CTIS Part Ii Submission Date
17-05-2024
Latest Decision Or Authorization Date
17-06-2024
Processing Time Days
31
Number Of Sites
12
Number Of Participants
28

Sites

Site Name
Azienda USL Toscana Sud Est
Department Name
Oncologia Medica
Contact Person Name
Alketa Hamzaj
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Oncology Department
Contact Person Name
Giuseppe Schepisi
Contact Person Email
giuseppe.schepisi@irst.emr.it
Site Name
Casa Sollievo Della Sofferenza
Department Name
UO Oncologia
Contact Person Name
Franco Morelli
Contact Person Email
f.morelli@operapadrepio.it
Site Name
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Contact Person Name
Laura Ghilardi
Contact Person Email
lghilardi@asst-pg23.it
Site Name
Centro Di Riferimento Oncologico Di Aviano
Contact Person Name
Lucia Fratino
Contact Person Email
lfratino@cro.it
Site Name
Azienda Ospedaliera Universitaria Integrata Verona
Contact Person Name
Andrea Zivi
Contact Person Email
andrea.zivi@aovr.veneto.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
UO di Radioterapia
Contact Person Name
Andrea Guerini
Contact Person Email
andrea.guerini1@unibs.it
Site Name
Azienda Socio Sanitaria Territoriale Di Cremona
Department Name
UO Oncologia
Contact Person Name
Bruno Perrucci
Contact Person Email
bruno.perrucci@asst-cremona.it
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Contact Person Name
Sandro Pignata
Contact Person Email
s.pignata@istitutotumori.na.it
Site Name
Azienda Provinciale Per I Servizi Sanitari
Department Name
Ospedale Santa Chiara di Trento
Contact Person Name
Orazio Caffo
Contact Person Email
orazio.caffo@apss.tn.it
Site Name
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Contact Person Name
Consuelo Buttigliero
Contact Person Email
consuelo.buttigliero@unito.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Contact Person Name
Francesco Massari
Contact Person Email
francesco.massari@aosp.bo.it

Germany

Earliest CTIS Part Ii Submission Date
17-05-2024
Latest Decision Or Authorization Date
13-06-2024
Processing Time Days
27
Number Of Sites
6
Number Of Participants
18

Sites

Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Klinik fuer Urologie
Contact Person Name
Maria De Santis
Contact Person Email
maria.de-santis@charite.de
Site Name
Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR
Contact Person Name
Tilman Todenhöfer
Contact Person Email
todenhoefer@studienurologie.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Urologie
Contact Person Name
Steffen Rausch
Site Name
Universitaetsmedizin Goettingen
Department Name
Department of Urology
Contact Person Name
Arne Strauss
Site Name
Goethe University Frankfurt
Department Name
Department of Urology
Contact Person Name
Clara Julia Humke
Contact Person Email
clara.humke@unimedizin-ffm.de
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Nationales Centrum fuer Tumorerkrankungen (NCT)
Contact Person Name
Stefanie Zschaebitz

Netherlands

Earliest CTIS Part Ii Submission Date
17-05-2024
Latest Decision Or Authorization Date
10-06-2024
Processing Time Days
24
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Haga Ziekenhuis
Department Name
Oncology
Contact Person Name
Danny Houtsma
Contact Person Email
d.houtsma@hagaziekenhuis.nl
Site Name
Meander Medisch Centrum
Contact Person Name
Joyce Maria van Dodewaard
Contact Person Email
jm.van.dodewaard@meandermc.nl

Belgium

Earliest CTIS Part Ii Submission Date
17-05-2024
Latest Decision Or Authorization Date
10-06-2024
Processing Time Days
24
Number Of Sites
6
Number Of Participants
24

Sites

Site Name
Cliniques Universitaires Saint-Luc
Department Name
Oncology
Contact Person Name
Jean Pascal Machiels
Site Name
Az Maria Middelares Gent
Contact Person Name
Christof Vulsteke
Contact Person Email
Christof.vulsteke@azmmsj.be
Site Name
Centre hospitalier universitaire de Liege
Contact Person Name
Brieuc Sautois
Contact Person Email
brieuc.sautois@chuliege.be
Site Name
AZ Sint-Lucas & Volkskliniek
Contact Person Name
Vincent Renard
Contact Person Email
vincent.renard@azstlucas.be
Site Name
Institut Jules Bordet
Contact Person Name
Spyridon Sideris
Contact Person Email
spyridon.sideris@bordet.be
Site Name
Algemeen Ziekenhuis Groeninge
Contact Person Name
Siska Van Bruwaene

Spain

Earliest CTIS Part Ii Submission Date
17-05-2024
Latest Decision Or Authorization Date
17-06-2024
Processing Time Days
31
Number Of Sites
15
Number Of Participants
55

Sites

Site Name
Hospital General Universitario Reina Sofia
Department Name
Servicio de Oncología Médica
Contact Person Name
Maria Jose Mendez Vidal
Contact Person Email
mjosemv@yahoo.es
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Contact Person Name
Aranzazu Gonzalez del Alba
Contact Person Email
aranglezalba@yahoo.es
Site Name
Hospital Universitario Central De Asturias
Department Name
Oncologia Medica
Contact Person Name
Carlos Alvarez Fernandez
Contact Person Email
carlos.alvfer@gmail.com
Site Name
Hospital Universitario De Navarra
Contact Person Name
Nuria Lainez Milagro
Site Name
Hospital Universitari Vall D Hebron
Department Name
Servicio de Oncologia Medica
Contact Person Name
Joaquin Mateo Valderrama
Contact Person Email
jmateo@vhio.net
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Servicio de Oncologia
Contact Person Name
Esteban Nogales Fernandez
Contact Person Email
esteban.nogales@gmail.com
Site Name
Fundacion Instituto Valenciano De Oncologia
Department Name
Bajo Unidad de Investigacion Clinica
Contact Person Name
Maria Jose Juan Fita
Contact Person Email
mjuanfi81@hotmail.com
Site Name
Hospital Germans Trias I Pujol
Department Name
Instituto Catalán de Oncología de Badalona
Contact Person Name
Albert Font Pous
Contact Person Email
afont@iconcologia.net
Site Name
Salut Sant Joan De Reus
Contact Person Name
Francisca Martinez Madueño
Site Name
Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada
Contact Person Name
Montserrat Domenech Santasusana
Contact Person Email
mdomenech@althaia.cat
Site Name
MD Anderson Cancer Center
Department Name
Servicio de Oncologia
Contact Person Name
Ana Lucrecia Ruiz Echeverria
Contact Person Email
alruiz@hospiten.es
Site Name
Hospital Clinic De Barcelona
Contact Person Name
Begona Mellado Gonzalez
Contact Person Email
bmellado@clinic.cat
Site Name
Hospital Universitario Lucus Augusti
Contact Person Name
Sergio Vazquez Estevez
Site Name
Hospital Clinico San Carlos
Department Name
Servicio de Oncología Médica Planta 0 Sur
Contact Person Name
Javier Puente Vazquez
Contact Person Email
javierpuente.hcsc@gmail.com
Site Name
Hospital Universitario Y Politecnico La Fe
Contact Person Name
Regina Girones Sarrio
Contact Person Email
girones_reg@gva.es

Norway

Earliest CTIS Part Ii Submission Date
17-05-2024
Latest Decision Or Authorization Date
12-06-2024
Processing Time Days
26
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Sykehuset Innlandet HF
Department Name
Department of Oncology
Contact Person Name
Havard Nja

France

Earliest CTIS Part Ii Submission Date
17-05-2024
Latest Decision Or Authorization Date
11-06-2024
Processing Time Days
25
Number Of Sites
12
Number Of Participants
32

Sites

Site Name
Centre Leon Berard
Department Name
Medical oncology
Contact Person Name
Aude Flechon
Contact Person Email
aude.flechon@lyon.unicancer.fr
Site Name
Institut Godinot
Contact Person Name
Jean-Christophe Eymard
Contact Person Email
jc.eymard@reims.unicancer.fr
Site Name
Institut De Cancerologie De Lorraine
Contact Person Name
Vincent Massard
Contact Person Email
v.massard@nancy.unicancer.fr
Site Name
Clinique Victor Hugo
Department Name
Radiotherapy - oncology
Contact Person Name
Ossama Didas
Contact Person Email
essaisdidas@ilcgroupe.fr
Site Name
Hopital Bichat - Claude Bernard
Department Name
Service d'urologie
Contact Person Name
Evanguelos Xylinas
Contact Person Email
evanguelos.xylinas@aphp.fr
Site Name
Institut De Cancerologie Strasbourg Europe
Contact Person Name
Philippe Barthelemy
Contact Person Email
p.barthelemy@icans.eu
Site Name
Centre Hospitalier Lyon Sud
Department Name
Service Oncologie Medicale
Contact Person Name
Denis Maillet
Contact Person Email
denis.maillet@chu-lyon.fr
Site Name
Hopital privé Le Bois
Contact Person Name
Segolene Hautecloque
Contact Person Email
shautecloque@clinique-psv.fr
Site Name
Centre Hospitalier Prive Saint-Gregoire
Department Name
Service Oncologie
Contact Person Name
Aurelien Gobert
Contact Person Email
aurelien.gobert@icrb.fr
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Institut de Cancerologie et Hematologie
Contact Person Name
Benjamin Auberger
Contact Person Email
benjamin.auberger@chu-brest.fr
Site Name
Institut Gustave Roussy
Department Name
Medical Oncology
Contact Person Name
Ronan Flippot
Contact Person Email
Ronan.flippot@gustaveroussy.fr
Site Name
Clinique Belharra
Department Name
Oncologie
Contact Person Name
Maciej Rotarski
Contact Person Email
maciej.rotarski@copb.eu

Bulgaria

Earliest CTIS Part Ii Submission Date
17-05-2024
Latest Decision Or Authorization Date
10-06-2024
Processing Time Days
24
Number Of Sites
3
Number Of Participants
11

Sites

Site Name
Multiprofile Hospital For Active Treatment-Uni Hospital Ltd.
Department Name
Department of Medical Oncology
Contact Person Name
Rossitza Krasteva Ruseva
Contact Person Email
rkr_2002@yahoo.com
Site Name
Complex Oncological Center - Shumen EOOD
Department Name
Department of Medical Oncology
Contact Person Name
Nikolay Nachkov Nikolov
Contact Person Email
onconick@yahoo.com
Site Name
Complex Oncological Center Plovdiv EOOD
Department Name
First Department of Medical Oncology and Oncology Diseases in Gastroenterology
Contact Person Name
Antoaneta Dimitrova Tomova
Contact Person Email
dr.tomova@gmail.com

Czechia

Earliest CTIS Part Ii Submission Date
17-05-2024
Latest Decision Or Authorization Date
11-06-2024
Processing Time Days
25
Number Of Sites
4
Number Of Participants
8

Sites

Site Name
Fakultni Nemocnice Ostrava
Department Name
Department of Oncology
Contact Person Name
Zuzana Ruzickova
Contact Person Email
zuzana.ruzickova@fno.cz
Site Name
Fakultni Nemocnice Kralovske Vinohrady
Department Name
Radioterapeuticka a onkologicka klinika
Contact Person Name
Jan Dvorak
Contact Person Email
jan.dvorak@fnkv.cz
Site Name
Fakultni Nemocnice V Motole
Department Name
Onkologická klinika 2. LF UK a FN Motol
Contact Person Name
Tomas Buchler
Contact Person Email
tomas.buchler@fnmotol.cz
Site Name
University Hospital Olomouc
Department Name
Onkologicka klinika
Contact Person Name
Bohuslav Melichar
Contact Person Email
bohuslav.melichar@fnol.cz

Sponsor

Primary sponsor

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

Contract research organisations

Name
Icon Clinical Research Limited
Responsibilities
Storage laboratory for samples: PK samples; Prep D1; ctDNA;
Name
Syneos Health UK Limited
Responsibilities
Ethic Committee submissions; other sponsor support duties

Third parties

  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Storage laboratory for the following samples: PK samples; Prep D1; ctDNA;","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Icon Laboratory Services Inc.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Foundation Medicine Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Syneos Health UK Limited","duties_or_roles":"Ethic Committee submissions; other sponsor duties (codes: 1, 2, 15)","organisation_type":"Pharmaceutical company"}
  • {"country":"Canada","full_name":"Clinical Logistics Inc.","duties_or_roles":"1. Preparation of lab kits &labels 2. Preparation of lab manuals & other lab documents 3. Inventory","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Xtandi - 40 mg soft capsules
Active Substance
Enzalutamide
Modality
Small molecule
Routes Of Administration
Oral
Route
ORAL
Authorisation Status
Marketing authorisation EU/1/13/846/001 (as listed in Part I product info)
Maximum Dose
160 mg (maxDailyDoseAmount listed in Part I)
Investigational Product Name
TALAZOPARIB
Active Substance
Talazoparib
Modality
Small molecule
Routes Of Administration
Oral
Route
ORAL
Maximum Dose
0.5 mg (maxDailyDoseAmount listed in Part I)
Investigational Product Name
Talazoparib placebo
Modality
Other
Combination Treatment
Yes

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