Trial Title:
A Study for the Participants With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Treated With Androgen Deprivation Therapy (ADT) Plus Apalutamide or Enzalutamide
NCT ID:
NCT05901649
Condition:
Metastatic Hormone-sensitive Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Hypersensitivity
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Apalutamide
Description:
No interventions will be administered as a part of this study. Participants will receive
apalutamide as per their routine clinical practice.
Arm group label:
Apalutamide Plus Androgen Deprivation Therapy (ADT)
Other name:
ERLEADA
Intervention type:
Drug
Intervention name:
Enzalutamide
Description:
No interventions will be administered as a part of this study. Participants will receive
enzalutamide as per their routine clinical practice.
Arm group label:
Enzalutamide Plus Androgen Deprivation Therapy (ADT)
Other name:
XTANDI
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).
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Klinikum Wels Grieskirchen
Address:
City:
Wels
Zip:
4600
Country:
Austria
Status:
Recruiting
Facility:
Name:
Akh Wien
Address:
City:
Wien
Zip:
1090
Country:
Austria
Status:
Recruiting
Facility:
Name:
Institut Sainte Catherine
Address:
City:
Avignon
Zip:
84918
Country:
France
Status:
Recruiting
Facility:
Name:
Institut Bergonie
Address:
City:
Bordeaux
Zip:
33000
Country:
France
Status:
Recruiting
Facility:
Name:
Polyclinique Bordeaux Nord Acquitaine
Address:
City:
Bordeaux
Zip:
33077
Country:
France
Status:
Recruiting
Facility:
Name:
Clinique Pasteur- Lanroze
Address:
City:
Brest
Zip:
29229
Country:
France
Status:
Recruiting
Facility:
Name:
Hopital Michallon CHU Grenoble Alpes
Address:
City:
La Tronche
Zip:
38700
Country:
France
Status:
Recruiting
Facility:
Name:
Hôpital Edouard Herriot
Address:
City:
Lyon
Zip:
69003
Country:
France
Status:
Recruiting
Facility:
Name:
Centre d'oncologie de Gentilly
Address:
City:
Nancy
Zip:
54100
Country:
France
Status:
Recruiting
Facility:
Name:
CHU Nîmes
Address:
City:
Nimes
Zip:
30029
Country:
France
Status:
Recruiting
Facility:
Name:
Hopital Europeen Georges-Pompidou
Address:
City:
Paris
Zip:
75015
Country:
France
Status:
Recruiting
Facility:
Name:
Hopital Tenon
Address:
City:
Paris
Zip:
75020
Country:
France
Status:
Recruiting
Facility:
Name:
Centre Hospitalier Rene Dubos Pontoise
Address:
City:
Pontoise
Zip:
95303
Country:
France
Status:
Recruiting
Facility:
Name:
Clinique de la Croix du Sud
Address:
City:
Quint-Fonsegrives
Zip:
31130
Country:
France
Status:
Recruiting
Facility:
Name:
Centre Hospitalier Prive
Address:
City:
Saint-Grégoire
Zip:
35760
Country:
France
Status:
Recruiting
Facility:
Name:
Clinique Sainte Anne
Address:
City:
Strasbourg
Zip:
67000
Country:
France
Status:
Recruiting
Facility:
Name:
Hopital Foch
Address:
City:
Suresnes
Zip:
92150
Country:
France
Status:
Recruiting
Facility:
Name:
CHU de Toulouse
Address:
City:
Toulouse cedex 9
Zip:
31059
Country:
France
Status:
Recruiting
Facility:
Name:
Urologie Dierdorf
Address:
City:
Dierdorf
Zip:
56269
Country:
Germany
Status:
Recruiting
Facility:
Name:
St. Elisabeth Hospital Leipzig
Address:
City:
Dresden
Zip:
01307
Country:
Germany
Status:
Recruiting
Facility:
Name:
Urologicum Duisburg
Address:
City:
Duisburg
Zip:
47169
Country:
Germany
Status:
Recruiting
Facility:
Name:
Urologisches Zentrum Mittelhessen
Address:
City:
Gladenbach
Zip:
35075
Country:
Germany
Status:
Recruiting
Facility:
Name:
Praxis Dr. Serkan Filiz
Address:
City:
Hamburg
Zip:
22880
Country:
Germany
Status:
Completed
Facility:
Name:
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Address:
City:
Mainz
Zip:
55131
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitaetsklinikum Muenster
Address:
City:
Muenster
Zip:
48149
Country:
Germany
Status:
Recruiting
Facility:
Name:
Krankenhaus Barmherzige Brüder Regensburg
Address:
City:
Regensburg
Zip:
93049
Country:
Germany
Status:
Recruiting
Facility:
Name:
Anticancer Oncology Hospital of Athens Agios Savvas
Address:
City:
Athens
Zip:
11522
Country:
Greece
Status:
Recruiting
Facility:
Name:
Attikon University General Hospital of Attica
Address:
City:
Athens
Zip:
12462
Country:
Greece
Status:
Recruiting
Facility:
Name:
General Oncology Hospital of Kifisias "Agioi Anargyroi
Address:
City:
Athens
Zip:
14564
Country:
Greece
Status:
Recruiting
Facility:
Name:
Alexandra General Hospital of Athens
Address:
City:
Athina
Zip:
115 28
Country:
Greece
Status:
Recruiting
Facility:
Name:
University Hospital of Heraklion
Address:
City:
Heraklion
Zip:
71110
Country:
Greece
Status:
Recruiting
Facility:
Name:
Papageorgiou General Hospital Of Thessaloniki
Address:
City:
Thessaloniki
Zip:
TK 56403
Country:
Greece
Status:
Recruiting
Facility:
Name:
Hosp Univ A Coruna
Address:
City:
A Coruna
Zip:
15006
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp. Torrecardenas
Address:
City:
Almería
Zip:
04009
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp. Gral. Univ. de Castellon
Address:
City:
Castellon
Zip:
12004
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp. Puerta Del Mar
Address:
City:
Cádiz
Zip:
11009
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp. Univ. de Canarias
Address:
City:
La Laguna
Zip:
38320
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp. Univ. Lucus Augusti
Address:
City:
Lugo
Zip:
27003
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp Regional Univ de Malaga
Address:
City:
Malaga
Zip:
29010
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp. Clinico Univ. de Santiago
Address:
City:
Santiago de Compostela
Zip:
15706
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp. Univ. I Politecni La Fe
Address:
City:
Valencia
Zip:
46026
Country:
Spain
Status:
Recruiting
Facility:
Name:
Frimley Health NHS Foundation Trust
Address:
City:
Berkshire
Zip:
SL2 4HL
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Torbay Hospital-Devon
Address:
City:
Devon
Zip:
TQ2 7AA
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Royal Surrey County Hospital NHS Trust
Address:
City:
Guildford
Zip:
GU2 7XX
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Royal Free London NHS Foundation Trust
Address:
City:
London
Zip:
NW3 2QG
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Pennine Care Nhs Foundation Trust
Address:
City:
Oldham
Zip:
OL1 2JH
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Scunthorpe General Hospital
Address:
City:
Scunthorpe
Zip:
DN15 7BH
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
University Hospitals Sussex NHS Foundation Trust Worthing Hospital
Address:
City:
Worthing
Zip:
BN11 2DH
Country:
United Kingdom
Status:
Recruiting
Start date:
July 5, 2023
Completion date:
June 5, 2026
Lead sponsor:
Agency:
Janssen-Cilag Ltd.
Agency class:
Industry
Source:
Janssen-Cilag Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05901649
