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| ID | Type | Description | Link |
|---|---|---|---|
| D0817R00074 | Other Identifier | AstraZeneca |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
PROceed is a multisite, prospective, observational study that describes the real-world use and clinical experience of mCRPC patients treated with the combination of olaparib and abiraterone in the mCRPC setting. Clinical outcomes will be assessed in patients who are either NHA-naive or NHA-exposed prior to initiating olaparib + abiraterone treatment, respectively. Patient demographic and clinical characteristics, as well as treatment received prior and subsequent to olaparib + abiraterone, will also be described. The study plans to enroll patients for a maximum of 2 years and follow up patients from initiation of olaparib until 1 year post last patient in.
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| Measure | Description | Time Frame |
|---|---|---|
| Time to treatment discontinuation | Time to treatment discontinuation (TTD) event-free rate at 6 months and 12 months will be assessed among patients treated with olaparib + abiraterone in 1L mCRPC setting by prior NHA exposure status (NHA-exposed and NHA-naive), respectively. TTD is defined as the time from initiation of olaparib therapy until end date of olaparib therapy or death due to any cause. | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first subsequent therapy | Time to first subsequent therapy (TFST) in mCRPC patients treated with olaparib + abiraterone. TFST is defined as the time from olaparib initiation to the earlier of the first subsequent anticancer therapy start date following olaparib discontinuation or death due to any cause. | Up to 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will consist of patients with a confirmed mCRPC diagnosis that has initiated the combination of olaparib and abiraterone through routine clinical practice at participating sites in Germany.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | Contact | 1-877-240-9479 | information.center@astrazeneca.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Recruiting | Aschaffenburg | Germany | |||
| Research Site |
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal
Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
"Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
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AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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| Recruiting |
| Augsburg |
| Germany |
| Research Site | Recruiting | Bergisch Gladbach | Germany |
| Research Site | Recruiting | Berlin | Germany |
| Research Site | Recruiting | Bonn | Germany |
| Research Site | Recruiting | Cologne | Germany |
| Research Site | Recruiting | Dresden | Germany |
| Research Site | Recruiting | Duisburg | Germany |
| Research Site | Recruiting | Eisenach | Germany |
| Research Site | Recruiting | Eisleben Lutherstadt | Germany |
| Research Site | Recruiting | Frankfurt | Germany |
| Research Site | Recruiting | Greifswald | Germany |
| Research Site | Recruiting | Halle | Germany |
| Research Site | Recruiting | Hamburg | Germany |
| Research Site | Recruiting | Hanover | Germany |
| Research Site | Recruiting | Heidelberg | Germany |
| Research Site | Recruiting | Heinsberg | Germany |
| Research Site | Recruiting | Herzogenaurach | Germany |
| Research Site | Recruiting | Leipzig | Germany |
| Research Site | Recruiting | Lübeck | Germany |
| Research Site | Recruiting | Lüneburg | Germany |
| Research Site | Recruiting | Magdeburg | Germany |
| Research Site | Recruiting | Marburg | Germany |
| Research Site | Recruiting | Mülheim | Germany |
| Research Site | Recruiting | Münster | Germany |
| Research Site | Recruiting | Neunkirchen | Germany |
| Research Site | Recruiting | Nuremberg | Germany |
| Research Site | Recruiting | Rüsselsheim am Main | Germany |
| Research Site | Recruiting | Saalfeld | Germany |
| Research Site | Recruiting | Speyer | Germany |
| Research Site | Recruiting | Trier | Germany |
| Research Site | Recruiting | Tübingen | Germany |
| Research Site | Recruiting | Westerstede | Germany |
| Research Site | Recruiting | Wetzlar | Germany |