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NCT04809584 Clinical Trial

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

Prostate Cancer Clinical Trial

Official title:
18F-DCFPyL PET/MRI for Detection of Regional Nodal and Distant Metastases in Patients With Intermediate and High-risk Prostate Cancer

Clinical Trial Details — Status: Temporarily not available

Administrative data
NCT number NCT04809584
Other study ID # IRB-58503
Secondary ID PROS0103IRB-5850
Status Temporarily not available
Phase
First received
Last updated

Study information
Verified date May 2023
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Temporarily not available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Male
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• F18-DCFPyL
Participant will be injected iv with 9 mCi ± 20% of 18F-DCFPyL
• Gadolinium
Contrast agent
Procedure:
• Positron emission tomography (PET)/Magnetic Resonance Imaging (MRI) Scan
Imaging test that combines PET (positron emission tomography) and MRI (magnetic resonance imaging)

Locations
Country Name City State
United States Stanford University Stanford California

Sponsors (1)
Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

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