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Real-World study compares two prostate cancer drug combos

NCT ID NCT05901649

Knowledge-focused Sponsor: Janssen-Cilag Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This study follows about 500 men with advanced prostate cancer that still responds to hormone therapy. Researchers are comparing two drug combinations (apalutamide or enzalutamide plus standard hormone therapy) to see how well they work in real-world settings. The goal is to understand differences in cancer control, quality of life, and side effects like fatigue and anxiety.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

505 people

The number who actually took part.

Started

Jul 2023

Finished

Jun 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Participants with high-risk metastatic hormone-sensitive prostate cancer (mHSPC) who will be treated with either apalutamide or enzalutamide plus androgen deprivation therapy (ADT) under routine clinical practice will be observed.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Must have a histologically or cytologically-confirmed diagnosis of adenocarcinoma of the prostate * Must have documented metastatic hormone-sensitive prostate cancer (mHSPC) * Must have agreed with the treating physician the initiation of either apalutamide or enzalutamide (plus androgen deprivation therapy \[ADT\]) treatment, per the treating physician's decision, prior to enrollment into the study * Must sign, and/or their legally acceptable representative where applicable must sign, a participation agreement/ informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements * Must have baseline prostate-specific antigen (PSA) captured within 30 days prior to the first administration of apalutamide or enzalutamide * Must agree to complete patient-reported outcomes (PROs) during the study, including the baseline ones collected before the first administration of apalutamide or enzalutamide Exclusion Criteria: * Has already received or is currently receiving either apalutamide or enzalutamide, or any other novel hormonal treatments (including but not limited to abiraterone acetate and darolutamide) * Is currently receiving an active treatment for prostate cancer as part of an interventional study * Has a progression under ADT treatment (and thus became castrate-resistant) prior to start of apalutamide or enzalutamide treatment * Has received ADT treatment for mHSPC for more than 2 months prior to apalutamide or enzalutamide treatment initiation or ADT treatment was administered for earlier disease stages within the last 12 months prior to apalutamide or enzalutamide treatment initiation * Has received prior docetaxel for the treatment of mHSPC * Participants is not treated in line with current Summary of Product Characteristics for apalutamide or enzalutamide

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Conditions

The condition(s) this trial relates to.

metastatic prostate carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic hormone sensitive prostate cancer

Contacts and locations

Locations

  • Akh Wien

    Vienna, 1090, Austria

  • Alexandra General Hospital of Athens

    Athens, 115 28, Greece

  • Anticancer Oncology Hospital of Athens Agios Savvas

    Athens, 11522, Greece

  • Attikon University General Hospital of Attica

    Athens, 12462, Greece

  • CHU Nimes

    Nîmes, 30029, France

  • CHU de Toulouse

    Toulouse, 31059, France

  • Centre Hospitalier Prive

    Saint-Grégoire, 35760, France

  • Centre Hospitalier Rene Dubos Pontoise

    Pontoise, 95303, France

  • Centre d'oncologie de Gentilly

    Nancy, 54100, France

  • Clinique Pasteur- Lanroze

    Brest, 29229, France

  • Clinique Sainte Anne

    Strasbourg, 67000, France

  • Clinique de la Croix du Sud

    Quint-Fonsegrives, 31130, France

  • Dorset County Hospital Nhs Foundation Trust

    Dorchester, DT1 2JY, United Kingdom

  • General Oncology Hospital of Kifisias "Agioi Anargyroi

    Athens, 14564, Greece

  • Hopital Europeen Georges-Pompidou

    Paris, 75015, France

  • Hopital Foch

    Suresnes, 92150, France

  • Hopital Michallon CHU Grenoble Alpes

    La Tronche, 38700, France

  • Hopital Tenon

    Paris, 75020, France

  • Hosp Regional Univ de Malaga

    Málaga, 29010, Spain

  • Hosp Univ A Coruna

    A Coruña, 15006, Spain

  • Hosp. Clinico Univ. de Santiago

    Santiago de Compostela, 15706, Spain

  • Hosp. Gral. Univ. de Castellon

    Castellon, 12004, Spain

  • Hosp. Puerta Del Mar

    Cadiz, 11009, Spain

  • Hosp. Torrecardenas

    Almería, 04009, Spain

  • Hosp. Univ. I Politecni La Fe

    Valencia, 46026, Spain

  • Hosp. Univ. Lucus Augusti

    Lugo, 27003, Spain

  • Hosp. Univ. de Canarias

    San Cristóbal de La Laguna, 38320, Spain

  • Hôpital Edouard Herriot

    Lyon, 69003, France

  • Institut Bergonie

    Bordeaux, 33000, France

  • Institut Sainte Catherine

    Avignon, 84918, France

  • Klinikum Wels Grieskirchen

    Wels, 4600, Austria

  • Krankenhaus Barmherzige Brüder Regensburg

    Regensburg, 93049, Germany

  • Lewisham & Greenwich NHS Trust

    Berkshire, SL2 4HL, United Kingdom

  • Northern Care Alliance NHS Foundation Trust

    Oldham, OL1 2JH, United Kingdom

  • Northern Lincolnshire and Goole NHS Foundation Trust

    Scunthorpe, DN15 7BH, United Kingdom

  • Papageorgiou General Hospital Of Thessaloniki

    Thessaloniki, TK 56403, Greece

  • Polyclinique Bordeaux Nord Acquitaine

    Bordeaux, 33077, France

  • Praxis Dr. Serkan Filiz

    Hamburg, 22880, Germany

  • Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital

    Cornwall, TR1 3LJ, United Kingdom

  • Royal Free London NHS Foundation Trust

    London, NW3 2QG, United Kingdom

  • Royal Surrey County Hospital NHS Trust

    Guildford, GU2 7XX, United Kingdom

  • St. Elisabeth Hospital Leipzig

    Dresden, 01307, Germany

  • Taunton and Somerset NHS Foundation Trust

    Taunton, TA1 5DA, United Kingdom

  • Torbay Hospital-Devon

    Devon, TQ2 7AA, United Kingdom

  • Universitaetsklinikum Muenster

    Münster, 48149, Germany

  • Universitatsmedizin der Johannes Gutenberg Universitat Mainz

    Mainz, 55131, Germany

  • University College London Hospitals Nhs Foundation Trust

    London, NW1 2PG, United Kingdom

  • University General Hospital of Rio Patras

    Pátrai, 26504, Greece

  • University Hospital of Heraklion

    Heraklion, 71110, Greece

  • University Hospitals Sussex NHS Foundation Trust Worthing Hospital

    Worthing, BN11 2DH, United Kingdom

  • Urologicum Duisburg

    Duisburg, 47169, Germany

  • Urologie Dierdorf

    Dierdorf, 56269, Germany

  • Urologisches Zentrum Mittelhessen

    Gladenbach, 35075, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.