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The purpose of this study is to quantify the preferences for novel hormonal therapy (NHT) +/- androgen-deprivation therapy (ADT) vs ADT monotherapy among patients with non-metastatic hormone-sensitive prostate cancer (PC) in the United States (US), Germany, Spain, France, Italy, the United Kingdom (UK), South Korea, Australia, and Brazil, using a discrete choice experiment (DCE).
The study will collect data from eligible patients (six total) and physicians (six total) from one-on-one qualitative interviews and eligible patients from online surveys. Approximately 330 patients with PC will be recruited to complete the online DCE survey.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants | Participants will include urologists or oncologists for the physician interviews and prostate cancer patients for the patient interviews and surveys. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Other | No investigational drug will be administered to participants in this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patients' Preference weights for different treatment attributes | Preference data will be collected via online survey questionnaires designed using DCE method. | Up to 1 day |
| Patients' Overall Preference for a specific treatment profile (NHT +/- ADT or ADT monotherapy) | Preference data will be collected via online survey questionnaires designed using DCE method. | Up to 1 day |
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Inclusion Criteria:
Physician inclusion criteria
Exclusion Criteria:
Physician exclusion criteria
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Adult prostate cancer patients and urologists or oncologists who have cared for at least ten non-metastatic hormone-sensitive prostate cancer (nmHSPC) patients in the past year.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Global Development, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Analysis Group, Inc. | Boston | Massachusetts | 02199 | United States |
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |