Status:
APPROVED_FOR_MARKETING
18F-DCFPyL PET/MRI in Regional Nodal&Distant Metastases Detection in Intermediate &HR Prostate Cancer
Lead Sponsor:
Stanford University
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Brief Summary
The purpose of this research study is to see if patients' tumor can be identified by 18F-DCFPyL PET/MRI scan. The radioactive study agent, 18FDCFPyL, combined with PET/MRI scan may be able to identify...
Detailed Description
This is an expanded access study with a total of 100 participants with newly diagnosed intermediate or high-risk prostate cancer scheduled to undergo prostatectomy and lymph node dissection.
Eligibility Criteria
Inclusion
- Patient is older than 18-year-old
- Biopsy proven prostate adenocarcinoma
- Planned prostatectomy with lymph node dissection
- Intermediate to high-risk disease (as determined by elevated Prostate-specific antigen (PSA) \[PSA\>10\], T-stage \[T2b or greater\], Gleason score \[Gleason score \> 6\] or other risk factors)
- Able to provide written consent
- Karnofsky performance status of ³50 (or Eastern Cooperative Oncology Group (ECOG) /World Health Organization (WHO) equivalent)
Exclusion
- Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy including focal ablation techniques (HiFu)
- Androgen deprivation therapy or other neoadjuvant treatments prior to PET imaging surgery
- Metallic implants (contraindicated for MRI)
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04809584
Last Update
December 19 2024
Active Locations (1)
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1
Stanford University
Stanford, California, United States, 94304