Phase
Condition
Allergies & Asthma
Allergy
Prostate Cancer, Early, Recurrent
Treatment
Apalutamide
Enzalutamide
Clinical Study ID
Ages > 18 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Must have a histologically or cytologically-confirmed diagnosis of adenocarcinoma ofthe prostate
Must have documented metastatic hormone-sensitive prostate cancer (mHSPC)
Must have agreed with the treating physician the initiation of either apalutamide orenzalutamide (plus androgen deprivation therapy [ADT]) treatment, per the treatingphysician's decision, prior to enrollment into the study
Must sign, and/or their legally acceptable representative where applicable mustsign, a participation agreement/ informed consent form (ICF) allowing datacollection and source data verification in accordance with local requirements
Must have baseline prostate-specific antigen (PSA) captured within 30 days prior tothe first administration of apalutamide or enzalutamide
Must agree to complete patient-reported outcomes (PROs) during the study, includingthe baseline ones collected before the first administration of apalutamide orenzalutamide
Exclusion
Exclusion Criteria:
Has already received or is currently receiving either apalutamide or enzalutamide,or any other novel hormonal treatments (including but not limited to abirateroneacetate and darolutamide)
Is currently receiving an active treatment for prostate cancer as part of aninterventional study
Has a progression under ADT treatment (and thus became castrate-resistant) prior tostart of apalutamide or enzalutamide treatment
Has received ADT treatment for mHSPC for more than 2 months prior to apalutamide orenzalutamide treatment initiation or ADT treatment was administered for earlierdisease stages within the last 12 months prior to apalutamide or enzalutamidetreatment initiation
Has received prior docetaxel for the treatment of mHSPC
Participants is not treated in line with current Summary of Product Characteristicsfor apalutamide or enzalutamide
Study Design
Connect with a study center
Medizinische Universität Innsbruck
Innsbruck, 6020
AustriaSite Not Available
Krems University Hospital
Krems an der Donau, 3500
AustriaSite Not Available
Klinikum Wels Grieskirchen
Wels, 4600
AustriaSite Not Available
Klinikum Wels-Grieskirchen
Wels, 4600
AustriaActive - Recruiting
Akh Wien
Wien, 1090
AustriaSite Not Available
Institut Sainte Catherine
Avignon, 84918
FranceSite Not Available
Institut Bergonie
Bordeaux, 33000
FranceSite Not Available
Institut Bergonié
Bordeaux, 33000
FranceActive - Recruiting
Polyclinique Bordeaux Nord Acquitaine
Bordeaux, 33077
FranceSite Not Available
Clinique Pasteur- Lanroze
Brest, 29229
FranceSite Not Available
Hopital Michallon CHU Grenoble Alpes
La Tronche, 38700
FranceSite Not Available
Hôpital Edouard Herriot
Lyon, 69003
FranceSite Not Available
Centre d'oncologie de Gentilly
Nancy, 54100
FranceSite Not Available
CHU Nimes
Nimes, 30029
FranceSite Not Available
CHU Nîmes
Nimes, 30029
FranceActive - Recruiting
Hopital Europeen Georges-Pompidou
Paris, 75015
FranceSite Not Available
Hopital Tenon
Paris, 75020
FranceSite Not Available
Centre Hospitalier Rene Dubos Pontoise
Pontoise, 95303
FranceSite Not Available
Clinique de la Croix du Sud
Quint-Fonsegrives, 31130
FranceSite Not Available
Centre Hospitalier Prive
Saint-Grégoire, 35760
FranceSite Not Available
Clinique Sainte Anne
Strasbourg, 67000
FranceSite Not Available
Hopital Foch
Suresnes, 92150
FranceSite Not Available
CHU de Toulouse
Toulouse cedex 9, 31059
FranceSite Not Available
Ulrich Kube - Germany
Chemnitz, 09119
GermanySite Not Available
Urologie Dierdorf
Dierdorf, 56269
GermanySite Not Available
St. Elisabeth Hospital Leipzig
Dresden, 01307
GermanySite Not Available
Urologicum Duisburg
Duisburg, 47169
GermanySite Not Available
Urologisches Zentrum Mittelhessen
Gladenbach, 35075
GermanySite Not Available
Praxis Dr. Serkan Filiz
Hamburg, 22880
GermanySite Not Available
Universitatsmedizin der Johannes Gutenberg Universitat Mainz
Mainz, 55131
GermanySite Not Available
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131
GermanyActive - Recruiting
Universitaetsklinikum Muenster
Muenster, 48149
GermanySite Not Available
Urologisches Zentrum am Boxberg GP Derout/Pönicke/Becker - Germany
Neunkirchen, 66538
GermanySite Not Available
Krankenhaus Barmherzige Brüder Regensburg
Regensburg, 93049
GermanySite Not Available
Anticancer Oncology Hospital of Athens Agios Savvas
Athens, 11522
GreeceSite Not Available
Attikon University General Hospital of Attica
Athens, 12462
GreeceSite Not Available
General Hospital of Athens 'G. Gennimatas'
Athens, 115 27
GreeceSite Not Available
General Oncology Hospital of Kifisias "Agioi Anargyroi
Athens, 14564
GreeceSite Not Available
Alexandra General Hospital of Athens
Athina, 115 28
GreeceSite Not Available
University Hospital of Heraklion
Heraklion, 71110
GreeceSite Not Available
University General Hospital of Rio Patras
Patras, 26504
GreeceSite Not Available
'Papageorgiou' General Hospital of Thessaloniki
Thessaloniki, TK 56403
GreeceActive - Recruiting
Anticancer Hospital of Thessaloniki 'Theageneio'
Thessaloniki, 546 39
GreeceSite Not Available
Papageorgiou General Hospital Of Thessaloniki
Thessaloniki, TK 56403
GreeceSite Not Available
Hosp Univ A Coruna
A Coruna, 15006
SpainSite Not Available
Hosp. Univ. A Coruna
A Coruna, 15006
SpainSite Not Available
Hosp. Univ. A Coruna
A Coruña, 15006
SpainSite Not Available
Hosp. Univ. A Coruña
A Coruña, 15006
SpainActive - Recruiting
Hosp. Torrecardenas
Almería, 04009
SpainSite Not Available
Hosp. Gral. Univ. de Castellon
Castellon, 12004
SpainSite Not Available
Hosp. Puerta Del Mar
Cádiz, 11009
SpainSite Not Available
Hosp. Univ. de Canarias
La Laguna, 38320
SpainSite Not Available
Hosp. Univ. Lucus Augusti
Lugo, 27003
SpainSite Not Available
Hosp Regional Univ de Malaga
Malaga, 29010
SpainSite Not Available
Hosp. Regional Univ. de Malaga
Malaga, 29010
SpainSite Not Available
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, 15706
SpainSite Not Available
Hosp. Univ. I Politecni La Fe
Valencia, 46026
SpainSite Not Available
Frimley Health NHS Foundation Trust
Berkshire, SL2 4HL
United KingdomSite Not Available
Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital
Cornwall, TR1 3LJ
United KingdomSite Not Available
Torbay Hospital-Devon
Devon, TQ2 7AA
United KingdomSite Not Available
Dorset County Hospital Nhs Foundation Trust
Dorchester, DT1 2JY
United KingdomSite Not Available
Royal Surrey County Hospital NHS Trust
Guildford, GU2 7XX
United KingdomSite Not Available
Royal Free London NHS Foundation Trust
London, NW3 2QG
United KingdomSite Not Available
University College London Hospitals Nhs Foundation Trust
London, NW1 2PG
United KingdomSite Not Available
Pennine Care Nhs Foundation Trust
Oldham, OL1 2JH
United KingdomSite Not Available
Scunthorpe General Hospital
Scunthorpe, DN15 7BH
United KingdomSite Not Available
Taunton and Somerset NHS Foundation Trust
Taunton, TA1 5DA
United KingdomSite Not Available
University Hospitals Sussex NHS Foundation Trust Worthing Hospital
Worthing, BN11 2DH
United KingdomSite Not Available
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