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| ID | Type | Description | Link |
|---|---|---|---|
| 212082PCR4039 | Other Identifier | Janssen Pharmaceutica N.V., Belgium |
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The purpose of this observational study of metastatic castration-resistant prostate cancer (mCRPC) participants is to explore whether or not there are differences between participants treated with abiraterone acetate and enzalutamide on the health-related quality of life (HRQoL), Fatigue, Pain, Cognitive function and medical resource use (MRU).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Prostate Cancer (abiraterone acetate) | Participants with metastatic castration resistant prostate cancer (mCRPC) will receive abiraterone acetate at the discretion of his treating physician. | ||
| Participants with Prostate Cancer (enzalutamide) | Participants with metastatic castration resistant prostate cancer (mCRPC) will receive enzalutamide at the discretion of his treating physician. |
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| Measure | Description | Time Frame |
|---|---|---|
| Health Related Quality of Life (HRQoL) | 12 months | |
| Fatigue (BFI-SF) | Brief Fatigue Inventory-Short Form (BFI-SF) assess the severity of fatigue and the impact of fatigue on daily functioning. BFI-SF is a 4 item questionnaire. Each item is assessed on a 11point scale, ranges from 0 (No Fatigue) to 10 (As bad as you can imagine). Average from all 4 items will be used to derive the final score. | 12 months |
| Pain (BPI-SF) | Brief Pain Inventory-Short Form (BPI-SF) measures severity of pain, impact of pain on daily function, locations of pain, pain medications, and amount of pain relief in the past 24 hours or the past week. The BPI-SF includes 4 items measuring the intensity of pain which make up the pain intensity sub scales, assessed using 11 point numerical rating scales from "0"= no pain to "10" = pain as bad as you can imagine; 7 items that assess how much pain has interfered with 7 daily activities which make up the pain interference sub scale, assessed on a scale of 0, "Does not interfere" to 10, "completely interferes." This sub scale is typically scored as the mean of the 7 interference items; An additional item on the extent of pain relief. | 12 months |
| Cognitive Function (FACT-Cog) | The Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog) is a validated, 37 item, subjective neuro-psychological instrument designed to evaluate cancer participants perceived cognitive deterioration on their quality of life. The FACT-Cog is composed of 37 single items ranging from 04. Based on these single items 4 sub scales are calculated as perceived Cognitive Impairments (20 items; score range 0-80), impact On QOL (4 items; score range 0-16), comments From Others (4 items; score range 0-16), perceived Cognitive Abilities (9 items; score range 0-36). | 12 months |
| Medical Resource Use (MRU) |
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Inclusion Criteria:
Exclusion Criteria:
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Participants who will initiate treatment with abiraterone acetate or enzalutamide at study entry will be observed.
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutica N.V., Belgium Clinical Trial | Janssen Pharmaceutica N.V., Belgium | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Holstebro | Denmark | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31594705 | Derived | Thiery-Vuillemin A, Poulsen MH, Lagneau E, Ploussard G, Birtle A, Dourthe LM, Beal-Ardisson D, Pintus E, Trepiakas R, Lefresne F, Lukac M, Van Sanden S, Pissart G, Reid A; AQUARiUS Investigators. Impact of Abiraterone Acetate plus Prednisone or Enzalutamide on Patient-reported Outcomes in Patients with Metastatic Castration-resistant Prostate Cancer: Final 12-mo Analysis from the Observational AQUARiUS Study. Eur Urol. 2020 Mar;77(3):380-387. doi: 10.1016/j.eururo.2019.09.019. Epub 2019 Oct 5. |
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| 6 months prior to baseline until the end of the follow-up period (up to 18 months) |
| Næstved |
| Denmark |
| Odense | Denmark |
| Besançon | France |
| Beuvry | France |
| Bordeaux | France |
| Challes-les-Eaux | France |
| Chalon-sur-Saône | France |
| Dijon | France |
| Lyon | France |
| Marseille | France |
| Paris | France |
| Quimper | France |
| Saint-Mandé | France |
| Strasbourg | France |
| Toulouse | France |
| Berkshire | United Kingdom |
| Birmingham | United Kingdom |
| Bolton | United Kingdom |
| Derby | United Kingdom |
| Glasgow | United Kingdom |
| Lancaster | United Kingdom |
| Middlesbrough | United Kingdom |
| Oldham | United Kingdom |
| Sutton | United Kingdom |
| Wolverhampton | United Kingdom |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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