18F-DCFPyL PET/MRI in Regional Nodal&Distant Metastases Detection in Intermediate &HR Prostate Cancer

• Conditions: Prostate Cancer

• Registration Number: NCT04809584
• Lead Sponsor: Stanford University

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 smaller tumors than the standard of care contrast-enhanced CT or MRI scan.

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.

Study Timeline

• Study First Submitted: 2021-03-15
• Study First Submitted QC: 2021-03-19
• Study First Posted: 2021-03-22
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-19

Recruitment & Eligibility

• Status: APPROVED_FOR_MARKETING
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

1. Patient is older than 18-year-old
2. Biopsy proven prostate adenocarcinoma
3. Planned prostatectomy with lymph node dissection
4. 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)
5. Able to provide written consent
6. Karnofsky performance status of ³50 (or Eastern Cooperative Oncology Group (ECOG) /World Health Organization (WHO) equivalent)

Exclusion Criteria

1. Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy including focal ablation techniques (HiFu)
2. Androgen deprivation therapy or other neoadjuvant treatments prior to PET imaging surgery
3. Metallic implants (contraindicated for MRI)

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States