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| ID | Type | Description | Link |
|---|---|---|---|
| 212082PCR4038 | Other Identifier | Janssen Scientific Affairs, LLC |
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The purpose of this study is to characterize the tolerability profiles of enzalutamide and abiraterone acetate (with prednisone) -with specific focus on central nervous system (CNS) tolerability-and quality of life (QoL) after approximately 2 months of participants starting treatment with one of these agents for metastatic castration-resistant prostate cancer (mCRPC).
This is a multicenter (more than one study site), open-label (all people know the identity of the intervention), prospective, observational study to characterize the tolerability profile of treatment and quality of life (QoL) in participants receiving enzalutamide or abiraterone acetate (with prednisone) in a clinical practice setting. Approximately 100 male participants will be enrolled into this study, 50 participants will be recruited to each treatment arm. Participants will complete 2 scheduled on-site visits (Baseline and Month 2). Participants will primarily be observed for tolerability profiles of enzalutamide and abiraterone acetate (with prednisone) and safety over an observational period of 2 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enzalutamide Group | Participants who are receiving enzalutamide in a clinical practice setting will be observed for tolerability and quality of life. |
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| Abiraterone Acetate plus Prednisone group | Participants who are receiving abiraterone acetate in combination with prednisone in a clinical practice setting will be observed for tolerability and quality of life. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Other | Participants who are receiving enzalutamide or abiraterone acetate in combination with prednisone in a clinical practice setting will be observed for tolerability and quality of life. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Cogstate Tests at Month 2 | The Cogstate computerized cognitive test battery will be used as the assessment tool in this study. Overall, Cogstate measures a range of cognitive functions (example, psychomotor and memory function) using a number of different tests (example, choice reaction time, one-back memory). This battery of tests was chosen because it has been shown to be sensitive to very small cognitive changes and has been tested in cancer participants after chemotherapy. | Baseline and Month 2 |
| Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 at Month 2 | The EORTC QLQ-C30 is a questionnaire developed to assess the quality of Life (QoL) of cancer participants. The QLQ-C30 incorporates 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 3 symptom scales (fatigue, pain, and nausea and vomiting); and a global health and QoL scale. | Baseline and Month 2 |
| Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue subscale (FACIT-Fatigue) at Month 2 | The FACIT Measurement System is a collection of health-related QoL questionnaires targeted to the management of chronic illness. The fatigue subscale (FACIT-Fatigue) is a validated, 13-item questionnaire that assesses fatigue in people being treated for a chronic illness. | Baseline and Month 2 |
| Change From Baseline in Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) at Month 2 | The FACT-Cog is a validated, 37-item, subjective neuropsychological instrument designed to evaluate cancer participants perceived cognitive deterioration on their quality of life. | Baseline and Month 2 |
| Participant or Caregiver Observational Questionnaire (Survey) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) and Serious AEs | An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants who have a confirmed metastatic adenocarcinoma of the prostate will receive either enzalutamide or abiraterone acetate with prednisone for the treatment at the discretion of their treatment physician and in accordance with clinical practice.
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Scientific Affairs, LLC Clinical Trial | Janssen Scientific Affairs, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Homewood | Alabama | United States | ||||
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If a participant has a regular caregiver, the participating physician will ask the caregiver to complete an optional observational, sponsor-developed questionnaire (survey) pertaining to his/her perception of the participants tolerability of treatment and QoL.
| Baseline |
| Participant or Caregiver Observational Questionnaire (Survey) | If a participant has a regular caregiver, the participating physician will ask the caregiver to complete an optional observational, sponsor-developed questionnaire (survey) pertaining to his/her perception of the participants tolerability of treatment and QoL. | Month 2 |
| Screening up to follow-up (Approximately 2 Months) |
| La Mesa |
| California |
| United States |
| Wheat Ridge | Colorado | United States |
| Daytona Beach | Florida | United States |
| Indianapolis | Indiana | United States |
| Jeffersonville | Indiana | United States |
| Saint Clair Shores | Michigan | United States |
| Englewood | New Jersey | United States |
| Lawrenceville | New Jersey | United States |
| Morristown | New Jersey | United States |
| Poughkeepsie | New York | United States |
| Syracuse | New York | United States |
| Middleburg Heights | Ohio | United States |
| Springfield | Oregon | United States |
| Bala-Cynwyd | Pennsylvania | United States |
| Lancaster | Pennsylvania | United States |
| Charleston | South Carolina | United States |
| Myrtle Beach | South Carolina | United States |
| San Antonio | Texas | United States |
| Virginia Beach | Virginia | United States |
| 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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