Back to results18F-DCFPyL PET/MRI in Regional Nodal&Distant Metastases Detection in Intermediate &HR Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Temporarily not available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
F18-DCFPyL
Gadolinium
Positron emission tomography (PET)/Magnetic Resonance Imaging (MRI) Scan
Sponsored by
About this trial
This is an expanded access trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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)
Sites / Locations
- Stanford University
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04809584
Brief Title
18F-DCFPyL PET/MRI in Regional Nodal&Distant Metastases Detection in Intermediate &HR Prostate Cancer
Official Title
18F-DCFPyL PET/MRI for Detection of Regional Nodal and Distant Metastases in Patients With Intermediate and High-risk Prostate Cancer
Study Type
Expanded Access
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Temporarily not available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
F18-DCFPyL
Intervention Description
Participant will be injected iv with 9 mCi ± 20% of 18F-DCFPyL
Intervention Type
Drug
Intervention Name(s)
Gadolinium
Other Intervention Name(s)
motexafin gadolinium
Intervention Description
Contrast agent
Intervention Type
Procedure
Intervention Name(s)
Positron emission tomography (PET)/Magnetic Resonance Imaging (MRI) Scan
Intervention Description
Imaging test that combines PET (positron emission tomography) and MRI (magnetic resonance imaging)
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Men >/= 18 years of age will be recruited.
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrei H Iagaru
Organizational Affiliation
Stanford Universiy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
12. IPD Sharing Statement
Learn more about this trial
18F-DCFPyL PET/MRI in Regional Nodal&Distant Metastases Detection in Intermediate &HR Prostate Cancer
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