Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:24 AM
Ignite Modification Date:
2025-12-25 @ 4:24 AM
NCT ID:
NCT03459820
Brief Summary:
This is a multi-center, single-arm, open-label, phase III trial in patients with biopsy-proven prostate cancer. Patients will receive regular standard of clinical care. The only study-specific procedures will the administration of 18F-DCFPyL followed by a PET/CT scan. Differences in theoretical optimal clinical management based on a review of clinical, biochemical and radiographic subject data before and after 18F-DCFPyL PET/CT imaging by a central panel of experts will be captured at study completion.
Detailed Description:
Objectives: The primary objective of this study is to assess the differences in theoretical optimal clinical management afforded by 18F-DCFPyL PET/CT in prostate cancer patients as proposed by a central panel of experts.
Primary endpoint:
1\. Differences in theoretical optimal clinical management based on a review of clinical, histopathological, biochemical and radiographic subject data both before and after 18F-DCFPyL PET/CT imaging retrospectively by a central panel of experts.
Secondary endpoints:
1. 18F-DCFPyL PET/CT scan positivity fraction in patients with biochemically recurrent prostate cancer, stratified by PSA.
2. Immediate AE up to 90 minutes post-administration of 18F-DCFPyL.
Study:
NCT03459820
Study Brief:
Protocol Section:
NCT03459820