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| ID | Type | Description | Link |
|---|---|---|---|
| 56021927PCR4031 | Other Identifier | Janssen Research & Development, LLC |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apalutamide | Drug | No interventions will be administered as a part of this study. Participants will receive apalutamide as per their routine clinical practice. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Janssen-Cilag Ltd Clinical Trial | Janssen-Cilag Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akh Wien | Vienna | 1090 | Austria | |||
| Klinikum Wels Grieskirchen |
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| Enzalutamide | Drug | No interventions will be administered as a part of this study. Participants will receive enzalutamide as per their routine clinical practice. |
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| Up to 30 Months |
| Wels |
| 4600 |
| Austria |
| Institut Sainte Catherine | Avignon | 84918 | France |
| Institut Bergonie | Bordeaux | 33000 | France |
| Polyclinique Bordeaux Nord Acquitaine | Bordeaux | 33077 | France |
| Clinique Pasteur- Lanroze | Brest | 29229 | France |
| Hopital Michallon CHU Grenoble Alpes | La Tronche | 38700 | France |
| Hôpital Edouard Herriot | Lyon | 69003 | France |
| Centre d'oncologie de Gentilly | Nancy | 54100 | France |
| CHU Nimes | Nîmes | 30029 | France |
| Hopital Europeen Georges-Pompidou | Paris | 75015 | France |
| Hopital Tenon | Paris | 75020 | France |
| Centre Hospitalier Rene Dubos Pontoise | Pontoise | 95303 | France |
| Clinique de la Croix du Sud | Quint-Fonsegrives | 31130 | France |
| Centre Hospitalier Prive | Saint-Grégoire | 35760 | France |
| Clinique Sainte Anne | Strasbourg | 67000 | France |
| Hopital Foch | Suresnes | 92150 | France |
| CHU de Toulouse | Toulouse | 31059 | France |
| Urologie Dierdorf | Dierdorf | 56269 | Germany |
| St. Elisabeth Hospital Leipzig | Dresden | 01307 | Germany |
| Urologicum Duisburg | Duisburg | 47169 | Germany |
| Urologisches Zentrum Mittelhessen | Gladenbach | 35075 | Germany |
| Praxis Dr. Serkan Filiz | Hamburg | 22880 | Germany |
| Universitatsmedizin der Johannes Gutenberg Universitat Mainz | Mainz | 55131 | Germany |
| Universitaetsklinikum Muenster | Münster | 48149 | Germany |
| Krankenhaus Barmherzige Brüder Regensburg | Regensburg | 93049 | Germany |
| 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 |
| General Oncology Hospital of Kifisias "Agioi Anargyroi | Athens | 14564 | Greece |
| University Hospital of Heraklion | Heraklion | 71110 | Greece |
| University General Hospital of Rio Patras | Pátrai | 26504 | Greece |
| Papageorgiou General Hospital Of Thessaloniki | Thessaloniki | TK 56403 | Greece |
| Hosp Univ A Coruna | A Coruña | 15006 | Spain |
| Hosp. Torrecardenas | Almería | 04009 | Spain |
| Hosp. Puerta Del Mar | Cadiz | 11009 | Spain |
| Hosp. Gral. Univ. de Castellon | Castellon | 12004 | Spain |
| Hosp. Univ. Lucus Augusti | Lugo | 27003 | Spain |
| Hosp Regional Univ de Malaga | Málaga | 29010 | Spain |
| Hosp. Univ. de Canarias | San Cristóbal de La Laguna | 38320 | Spain |
| Hosp. Clinico Univ. de Santiago | Santiago de Compostela | 15706 | Spain |
| Hosp. Univ. I Politecni La Fe | Valencia | 46026 | Spain |
| Frimley Health NHS Foundation Trust | Berkshire | SL2 4HL | United Kingdom |
| Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital | Cornwall | TR1 3LJ | United Kingdom |
| Torbay Hospital-Devon | Devon | TQ2 7AA | United Kingdom |
| Dorset County Hospital Nhs Foundation Trust | Dorchester | DT1 2JY | United Kingdom |
| Royal Surrey County Hospital NHS Trust | Guildford | GU2 7XX | United Kingdom |
| University College London Hospitals Nhs Foundation Trust | London | NW1 2PG | United Kingdom |
| Royal Free London NHS Foundation Trust | London | NW3 2QG | United Kingdom |
| Pennine Care Nhs Foundation Trust | Oldham | OL1 2JH | United Kingdom |
| Scunthorpe General Hospital | Scunthorpe | DN15 7BH | United Kingdom |
| Taunton and Somerset NHS Foundation Trust | Taunton | TA1 5DA | United Kingdom |
| University Hospitals Sussex NHS Foundation Trust Worthing Hospital | Worthing | BN11 2DH | United Kingdom |
| ID | Term |
|---|---|
| C572045 | apalutamide |
| C540278 | enzalutamide |
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