A Study for the Participants With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Treated With Androgen Deprivation Therapy (ADT) Plus Apalutamide or Enzalutamide

Last updated: June 20, 2025
Sponsor: Janssen-Cilag Ltd.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Allergies & Asthma

Allergy

Prostate Cancer, Early, Recurrent

Treatment

Apalutamide

Enzalutamide

Clinical Study ID

NCT05901649
CR109320
56021927PCR4031
  • Ages > 18
  • Male

Study Summary

The purpose of this study is to assess the real-world outcomes differences between apalutamide or enzalutamide plus androgen deprivation therapy (ADT) for the treatment of participants with metastatic hormone-sensitive prostate cancer (mHSPC).

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

Total Participants: 516
Treatment Group(s): 2
Primary Treatment: Apalutamide
Phase:
Study Start date:
July 05, 2023
Estimated Completion Date:
June 05, 2026

Connect with a study center

  • Medizinische Universität Innsbruck

    Innsbruck, 6020
    Austria

    Site Not Available

  • Krems University Hospital

    Krems an der Donau, 3500
    Austria

    Site Not Available

  • Klinikum Wels Grieskirchen

    Wels, 4600
    Austria

    Site Not Available

  • Klinikum Wels-Grieskirchen

    Wels, 4600
    Austria

    Active - Recruiting

  • Akh Wien

    Wien, 1090
    Austria

    Site Not Available

  • Institut Sainte Catherine

    Avignon, 84918
    France

    Site Not Available

  • Institut Bergonie

    Bordeaux, 33000
    France

    Site Not Available

  • Institut Bergonié

    Bordeaux, 33000
    France

    Active - Recruiting

  • Polyclinique Bordeaux Nord Acquitaine

    Bordeaux, 33077
    France

    Site Not Available

  • Clinique Pasteur- Lanroze

    Brest, 29229
    France

    Site Not Available

  • Hopital Michallon CHU Grenoble Alpes

    La Tronche, 38700
    France

    Site Not Available

  • Hôpital Edouard Herriot

    Lyon, 69003
    France

    Site Not Available

  • Centre d'oncologie de Gentilly

    Nancy, 54100
    France

    Site Not Available

  • CHU Nimes

    Nimes, 30029
    France

    Site Not Available

  • CHU Nîmes

    Nimes, 30029
    France

    Active - Recruiting

  • Hopital Europeen Georges-Pompidou

    Paris, 75015
    France

    Site Not Available

  • Hopital Tenon

    Paris, 75020
    France

    Site Not Available

  • Centre Hospitalier Rene Dubos Pontoise

    Pontoise, 95303
    France

    Site Not Available

  • Clinique de la Croix du Sud

    Quint-Fonsegrives, 31130
    France

    Site Not Available

  • Centre Hospitalier Prive

    Saint-Grégoire, 35760
    France

    Site Not Available

  • Clinique Sainte Anne

    Strasbourg, 67000
    France

    Site Not Available

  • Hopital Foch

    Suresnes, 92150
    France

    Site Not Available

  • CHU de Toulouse

    Toulouse cedex 9, 31059
    France

    Site Not Available

  • Ulrich Kube - Germany

    Chemnitz, 09119
    Germany

    Site Not Available

  • Urologie Dierdorf

    Dierdorf, 56269
    Germany

    Site Not Available

  • St. Elisabeth Hospital Leipzig

    Dresden, 01307
    Germany

    Site Not Available

  • Urologicum Duisburg

    Duisburg, 47169
    Germany

    Site Not Available

  • Urologisches Zentrum Mittelhessen

    Gladenbach, 35075
    Germany

    Site Not Available

  • Praxis Dr. Serkan Filiz

    Hamburg, 22880
    Germany

    Site Not Available

  • Universitatsmedizin der Johannes Gutenberg Universitat Mainz

    Mainz, 55131
    Germany

    Site Not Available

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, 55131
    Germany

    Active - Recruiting

  • Universitaetsklinikum Muenster

    Muenster, 48149
    Germany

    Site Not Available

  • Urologisches Zentrum am Boxberg GP Derout/Pönicke/Becker - Germany

    Neunkirchen, 66538
    Germany

    Site Not Available

  • Krankenhaus Barmherzige Brüder Regensburg

    Regensburg, 93049
    Germany

    Site Not Available

  • Anticancer Oncology Hospital of Athens Agios Savvas

    Athens, 11522
    Greece

    Site Not Available

  • Attikon University General Hospital of Attica

    Athens, 12462
    Greece

    Site Not Available

  • General Hospital of Athens 'G. Gennimatas'

    Athens, 115 27
    Greece

    Site Not Available

  • General Oncology Hospital of Kifisias "Agioi Anargyroi

    Athens, 14564
    Greece

    Site Not Available

  • Alexandra General Hospital of Athens

    Athina, 115 28
    Greece

    Site Not Available

  • University Hospital of Heraklion

    Heraklion, 71110
    Greece

    Site Not Available

  • University General Hospital of Rio Patras

    Patras, 26504
    Greece

    Site Not Available

  • 'Papageorgiou' General Hospital of Thessaloniki

    Thessaloniki, TK 56403
    Greece

    Active - Recruiting

  • Anticancer Hospital of Thessaloniki 'Theageneio'

    Thessaloniki, 546 39
    Greece

    Site Not Available

  • Papageorgiou General Hospital Of Thessaloniki

    Thessaloniki, TK 56403
    Greece

    Site Not Available

  • Hosp Univ A Coruna

    A Coruna, 15006
    Spain

    Site Not Available

  • Hosp. Univ. A Coruna

    A Coruna, 15006
    Spain

    Site Not Available

  • Hosp. Univ. A Coruna

    A Coruña, 15006
    Spain

    Site Not Available

  • Hosp. Univ. A Coruña

    A Coruña, 15006
    Spain

    Active - Recruiting

  • Hosp. Torrecardenas

    Almería, 04009
    Spain

    Site Not Available

  • Hosp. Gral. Univ. de Castellon

    Castellon, 12004
    Spain

    Site Not Available

  • Hosp. Puerta Del Mar

    Cádiz, 11009
    Spain

    Site Not Available

  • Hosp. Univ. de Canarias

    La Laguna, 38320
    Spain

    Site Not Available

  • Hosp. Univ. Lucus Augusti

    Lugo, 27003
    Spain

    Site Not Available

  • Hosp Regional Univ de Malaga

    Malaga, 29010
    Spain

    Site Not Available

  • Hosp. Regional Univ. de Malaga

    Malaga, 29010
    Spain

    Site Not Available

  • Hosp. Clinico Univ. de Santiago

    Santiago de Compostela, 15706
    Spain

    Site Not Available

  • Hosp. Univ. I Politecni La Fe

    Valencia, 46026
    Spain

    Site Not Available

  • Frimley Health NHS Foundation Trust

    Berkshire, SL2 4HL
    United Kingdom

    Site Not Available

  • Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital

    Cornwall, TR1 3LJ
    United Kingdom

    Site Not Available

  • Torbay Hospital-Devon

    Devon, TQ2 7AA
    United Kingdom

    Site Not Available

  • Dorset County Hospital Nhs Foundation Trust

    Dorchester, DT1 2JY
    United Kingdom

    Site Not Available

  • Royal Surrey County Hospital NHS Trust

    Guildford, GU2 7XX
    United Kingdom

    Site Not Available

  • Royal Free London NHS Foundation Trust

    London, NW3 2QG
    United Kingdom

    Site Not Available

  • University College London Hospitals Nhs Foundation Trust

    London, NW1 2PG
    United Kingdom

    Site Not Available

  • Pennine Care Nhs Foundation Trust

    Oldham, OL1 2JH
    United Kingdom

    Site Not Available

  • Scunthorpe General Hospital

    Scunthorpe, DN15 7BH
    United Kingdom

    Site Not Available

  • Taunton and Somerset NHS Foundation Trust

    Taunton, TA1 5DA
    United Kingdom

    Site Not Available

  • University Hospitals Sussex NHS Foundation Trust Worthing Hospital

    Worthing, BN11 2DH
    United Kingdom

    Site Not Available

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