Metastatic Hormone-sensitive Prostate CancerArtemisPRONCT05901649
A Study for the Participants With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Treated With Androgen Deprivation Therapy (ADT) Plus Apalutamide or Enzalutamide
An observational study of Metastatic Hormone-sensitive Prostate Cancer, run by Janssen-Cilag Ltd. at 53 sites in 6 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Hormone-sensitive Prostate Cancer
- What is being tested?
- Apalutamide and Enzalutamide
- How many people
- 505 participants
- Where
- 53 sitesin 6 countries
- Study dates
- 5 Jul 2023to 16 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
53 sites in 6 countries.
53 sites in 6 countries
France16 sites
Institut Sainte Catherine
Avignon, 84918
Institut Bergonie
Bordeaux, 33000
Polyclinique Bordeaux Nord Acquitaine
Bordeaux, 33077
Clinique Pasteur- Lanroze
Brest, 29229
Hopital Michallon CHU Grenoble Alpes
La Tronche, 38700
Hôpital Edouard Herriot
Lyon, 69003
Centre d'oncologie de Gentilly
Nancy, 54100
CHU Nimes
Nîmes, 30029
Hopital Europeen Georges-Pompidou
Paris, 75015
Hopital Tenon
Paris, 75020
Centre Hospitalier Rene Dubos Pontoise
Pontoise, 95303
Clinique de la Croix du Sud
Quint-Fonsegrives, 31130
Centre Hospitalier Prive
Saint-Grégoire, 35760
Clinique Sainte Anne
Strasbourg, 67000
Hopital Foch
Suresnes, 92150
CHU de Toulouse
Toulouse, 31059
United Kingdom11 sites
Lewisham & Greenwich NHS Trust
Berkshire, SL2 4HL
Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital
Cornwall, TR1 3LJ
Torbay Hospital-Devon
Devon, TQ2 7AA
Dorset County Hospital Nhs Foundation Trust
Dorchester, DT1 2JY
Royal Surrey County Hospital NHS Trust
Guildford, GU2 7XX
University College London Hospitals Nhs Foundation Trust
London, NW1 2PG
Royal Free London NHS Foundation Trust
London, NW3 2QG
Northern Care Alliance NHS Foundation Trust
Oldham, OL1 2JH
Northern Lincolnshire and Goole NHS Foundation Trust
Scunthorpe, DN15 7BH
Taunton and Somerset NHS Foundation Trust
Taunton, TA1 5DA
University Hospitals Sussex NHS Foundation Trust Worthing Hospital
Worthing, BN11 2DH
Spain9 sites
Hosp Univ A Coruna
A Coruña, 15006
Hosp. Torrecardenas
Almería, 04009
Hosp. Puerta Del Mar
Cadiz, 11009
Hosp. Gral. Univ. de Castellon
Castellon, 12004
Hosp. Univ. Lucus Augusti
Lugo, 27003
Hosp Regional Univ de Malaga
Málaga, 29010
Hosp. Univ. de Canarias
San Cristóbal de La Laguna, 38320
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, 15706
Hosp. Univ. I Politecni La Fe
Valencia, 46026
Germany8 sites
Urologie Dierdorf
Dierdorf, 56269
St. Elisabeth Hospital Leipzig
Dresden, 01307
Urologicum Duisburg
Duisburg, 47169
Urologisches Zentrum Mittelhessen
Gladenbach, 35075
Praxis Dr. Serkan Filiz
Hamburg, 22880
Universitatsmedizin der Johannes Gutenberg Universitat Mainz
Mainz, 55131
Universitaetsklinikum Muenster
Münster, 48149
Krankenhaus Barmherzige Brüder Regensburg
Regensburg, 93049
Greece7 sites
Alexandra General Hospital of Athens
Athens, 115 28
Anticancer Oncology Hospital of Athens Agios Savvas
Athens, 11522
Attikon University General Hospital of Attica
Athens, 12462
General Oncology Hospital of Kifisias "Agioi Anargyroi
Athens, 14564
University Hospital of Heraklion
Heraklion, 71110
University General Hospital of Rio Patras
Pátrai, 26504
Papageorgiou General Hospital Of Thessaloniki
Thessaloniki, TK 56403
About this study
Official title: Prospective, Multi-Country, Observational Study of Clinical Outcomes for Participants With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Treated With ADT Plus Apalutamide or Enzalutamide Under Routine Clinical Practice (ArtemisPRO)
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).
- Being tested
- Apalutamide, Enzalutamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApalutamideDrug
Also called ERLEADA
No interventions will be administered as a part of this study. Participants will receive apalutamide as per their routine clinical practice.
EnzalutamideDrug
Also called XTANDI
No interventions will be administered as a part of this study. Participants will receive enzalutamide as per their routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Enzalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Up to 30 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study start5 Jul 2023
- Primary completion16 Jun 2026
- Study completion16 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Hormone-sensitive Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 505 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag Ltd Clinical Trial, Study director, Janssen-Cilag Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05901649
- Sponsor's protocol ID
- CR109320
- Other IDs
- 56021927PCR4031
- Acronym
- ArtemisPRO
- Status last verified
- Jul 2026
- First submitted
- 5 Jun 2023
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-Country, Observational Study of Clinical Outcomes for Participants With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Treated With ADT Plus Apalutamide or Enzalutamide Under Routine Clinical Practice (ArtemisPRO)
- ClinicalTrials.gov ID
- NCT05901649
- Acronym / sponsor ID
- ArtemisPRO / CR109320
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 505 participants (actual)
- Lead sponsor
- Janssen-Cilag Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 16 Jun 2026 (actual)
- Study completion
- 16 Jun 2026 (actual)
- First posted
- 13 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apalutamide Plus Androgen Deprivation Therapy (ADT) | – | Drug: ApalutamideParticipants 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. |
| Enzalutamide Plus Androgen Deprivation Therapy (ADT) | – | Drug: EnzalutamideParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApalutamideAlso: ERLEADANo interventions will be administered as a part of this study. Participants will receive apalutamide as per their routine clinical practice. | Drug | Apalutamide Plus Androgen Deprivation Therapy (ADT) |
| EnzalutamideAlso: XTANDINo interventions will be administered as a part of this study. Participants will receive enzalutamide as per their routine clinical practice. | Drug | Enzalutamide Plus Androgen Deprivation Therapy (ADT) |
Primary outcome
Percentage of Participants With Prostate-specific Antigen (PSA) Level <0.2 ng/mL at Month 3
Time frame: At month 3
Percentage of participants with PSA level less than (<)0.2 nanogram per milliliter (ng/mL) at month 3 will be reported.
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
Time frame: Up to 30 Months
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.
Cognitive Functioning as Assessed by Partial Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) Questionnaire
Time frame: Up to 30 Months
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.
Fatigue as Assessed by Brief Fatigue Inventory-Short Form (BFI-SF) Questionnaire
Time frame: Up to 30 Months
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).
Prostate-specific Antigen (PSA) Anxiety as Assessed by Memorial Anxiety Scale for Prostate Cancer (MAX-PC) Questionnaire
Time frame: Up to 30 Months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen-Cilag Ltd Clinical Trial study director
Janssen-Cilag Ltd.
53 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Hormone-sensitive Prostate Cancer, run by Janssen-Cilag Ltd. at 53 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in France, United Kingdom, Spain, Germany, Greece and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Prostate-specific Antigen (PSA) Level <0.2 ng/mL at Month 3 (time frame: At month 3). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.