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

NCT05901649 | Active Not Recruiting

• 2 other identifiers: CR10932056021927PCR4031
• Study Type: observational
• Target: 504
• Locations: 6 countries
• Sites: 53

Brief 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).

Conditions

Metastatic Hormone-sensitive Prostate Cancer

Outcome Measures

Primary Outcomes (5)

• Percentage of Participants With Prostate-specific Antigen (PSA) Level <0.2 ng/mL at Month 3

  Percentage of participants with PSA level less than (\<)0.2 nanogram per milliliter (ng/mL) at month 3 will be reported.

  At month 3

• Health-Related Quality of Life (HRQoL) as Assessed by Partial European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Questionnaire

  HRQoL of the participants will be assessed as partial EORTC QLQ-C30 questionnaire. EORTC QLQ-C30 scale scores range from 0 to 100. A high score for a functional scale represents a high level of functioning, whereas a high score for a symptom scale/single item represents a high level of symptom.

  Up to 30 Months

• Cognitive Functioning as Assessed by Partial Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) Questionnaire

  Cognitive function of the participants will be measured by the partial FACT-Cog (Version 3) questionnaire. The FACT-Cog score ranges from scale 0-148. The higher the total score, the better the cognitive function.

  Up to 30 Months

• Fatigue as Assessed by Brief Fatigue Inventory-Short Form (BFI-SF) Questionnaire

  Participant fatigue will be assessed by the BFI-SF questionnaire. The BFI-SF score range from scale 0-10. Scores are categorized as Mild (1-3), Moderate (4-6), and Severe (7-10).

  Up to 30 Months

• Prostate-specific Antigen (PSA) Anxiety as Assessed by Memorial Anxiety Scale for Prostate Cancer (MAX-PC) Questionnaire

  PSA anxiety of the participant will be assessed by the MAX-PC questionnaire. The MAX-PC total score ranges from scale 0 to 54. The MAX-PC is divided into three subscales: a) prostate cancer anxiety (PCA) range from 0 to 33, b) Prostate-Specific Antigen Anxiety (PSAA) ranges from 0 to 9, and c) fear of recurrence (FOR) ranges from 0 to 12.

  Up to 30 Months

Study Arms (2)

Apalutamide Plus Androgen Deprivation Therapy (ADT)

Participants with metastatic hormone-sensitive prostate cancer (mHSPC) will be observed who are being treated with apalutamide under clinical practice setting. Only data available per routine clinical practice will be collected within this study.

Drug: Apalutamide

Enzalutamide Plus Androgen Deprivation Therapy (ADT)

Participants with metastatic hormone-sensitive prostate cancer (mHSPC) will be observed who are being treated with enzalutamide under clinical practice setting. Only data available per routine clinical practice will be collected within this study.

Drug: Enzalutamide

Interventions

Apalutamide DRUG

No interventions will be administered as a part of this study. Participants will receive apalutamide as per their routine clinical practice.

Also known as: ERLEADA

Apalutamide Plus Androgen Deprivation Therapy (ADT)

Enzalutamide DRUG

No interventions will be administered as a part of this study. Participants will receive enzalutamide as per their routine clinical practice.

Also known as: XTANDI

Enzalutamide Plus Androgen Deprivation Therapy (ADT)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Cilag Ltd.: lead

Study Sites (53)

Akh Wien

Vienna, 1090, Austria

Location

Klinikum Wels Grieskirchen

Wels, 4600, Austria

Location

Institut Sainte Catherine

Avignon, 84918, France

Location

Institut Bergonie

Bordeaux, 33000, France

Location

Polyclinique Bordeaux Nord Acquitaine

Bordeaux, 33077, France

Location

Clinique Pasteur- Lanroze

Brest, 29229, France

Location

Hopital Michallon CHU Grenoble Alpes

La Tronche, 38700, France

Location

Hôpital Edouard Herriot

Lyon, 69003, France

Location

Centre d'oncologie de Gentilly

Nancy, 54100, France

Location

CHU Nimes

Nîmes, 30029, France

Location

Hopital Europeen Georges-Pompidou

Paris, 75015, France

Location

Hopital Tenon

Paris, 75020, France

Location

Centre Hospitalier Rene Dubos Pontoise

Pontoise, 95303, France

Location

Clinique de la Croix du Sud

Quint-Fonsegrives, 31130, France

Location

Centre Hospitalier Prive

Saint-Grégoire, 35760, France

Location

Clinique Sainte Anne

Strasbourg, 67000, France

Location

Hopital Foch

Suresnes, 92150, France

Location

CHU de Toulouse

Toulouse, 31059, France

Location

Urologie Dierdorf

Dierdorf, 56269, Germany

Location

St. Elisabeth Hospital Leipzig

Dresden, 01307, Germany

Location

Urologicum Duisburg

Duisburg, 47169, Germany

Location

Urologisches Zentrum Mittelhessen

Gladenbach, 35075, Germany

Location

Praxis Dr. Serkan Filiz

Hamburg, 22880, Germany

Location

Universitatsmedizin der Johannes Gutenberg Universitat Mainz

Mainz, 55131, Germany

Location

Universitaetsklinikum Muenster

Münster, 48149, Germany

Location

Krankenhaus Barmherzige Brüder Regensburg

Regensburg, 93049, Germany

Location

Alexandra General Hospital of Athens

Athens, 115 28, Greece

Location

Anticancer Oncology Hospital of Athens Agios Savvas

Athens, 11522, Greece

Location

Attikon University General Hospital of Attica

Athens, 12462, Greece

Location

General Oncology Hospital of Kifisias "Agioi Anargyroi

Athens, 14564, Greece

Location

University Hospital of Heraklion

Heraklion, 71110, Greece

Location

University General Hospital of Rio Patras

Pátrai, 26504, Greece

Location

Papageorgiou General Hospital Of Thessaloniki

Thessaloniki, TK 56403, Greece

Location

Hosp Univ A Coruna

A Coruña, 15006, Spain

Location

Hosp. Torrecardenas

Almería, 04009, Spain

Location

Hosp. Puerta Del Mar

Cadiz, 11009, Spain

Location

Hosp. Gral. Univ. de Castellon

Castellon, 12004, Spain

Location

Hosp. Univ. Lucus Augusti

Lugo, 27003, Spain

Location

Hosp Regional Univ de Malaga

Málaga, 29010, Spain

Location

Hosp. Univ. de Canarias

San Cristóbal de La Laguna, 38320, Spain

Location

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, 15706, Spain

Location

Hosp. Univ. I Politecni La Fe

Valencia, 46026, Spain

Location

Frimley Health NHS Foundation Trust

Berkshire, SL2 4HL, United Kingdom

Location

Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital

Cornwall, TR1 3LJ, United Kingdom

Location

Torbay Hospital-Devon

Devon, TQ2 7AA, United Kingdom

Location

Dorset County Hospital Nhs Foundation Trust

Dorchester, DT1 2JY, United Kingdom

Location

Royal Surrey County Hospital NHS Trust

Guildford, GU2 7XX, United Kingdom

Location

University College London Hospitals Nhs Foundation Trust

London, NW1 2PG, United Kingdom

Location

Royal Free London NHS Foundation Trust

London, NW3 2QG, United Kingdom

Location

Pennine Care Nhs Foundation Trust

Oldham, OL1 2JH, United Kingdom

Location

Scunthorpe General Hospital

Scunthorpe, DN15 7BH, United Kingdom

Location

Taunton and Somerset NHS Foundation Trust

Taunton, TA1 5DA, United Kingdom

Location

University Hospitals Sussex NHS Foundation Trust Worthing Hospital

Worthing, BN11 2DH, United Kingdom

Location

MeSH Terms

Interventions

apalutamide; enzalutamide

Study Officials

• Janssen-Cilag Ltd Clinical Trial

  Janssen-Cilag Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 13, 2023
• Study Start: July 5, 2023
• Primary Completion (Estimated): June 5, 2026
• Study Completion (Estimated): June 5, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); FR (16); DE (8); GR (7); GB (11); ES (9)