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

NCT04809584 | Unknown

• 2 other identifiers: IRB-58503PROS0103
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Interventions

F18-DCFPyL DRUG

Participant will be injected iv with 9 mCi ± 20% of 18F-DCFPyL

Gadolinium DRUG

Contrast agent

Also known as: motexafin gadolinium

Positron emission tomography (PET)/Magnetic Resonance Imaging (MRI) Scan PROCEDURE

Imaging test that combines PET (positron emission tomography) and MRI (magnetic resonance imaging)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Men \>/= 18 years of age will be recruited.
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94304, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

2-(3-(1-carboxy-5-((6-fluoropyridine-3-carbonyl)amino)pentyl)ureido)pentanedioic acid; Gadolinium; motexafin gadolinium; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Lanthanoid Series Elements; Metals, Rare Earth; Elements; Inorganic Chemicals; Metals; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Andrei H Iagaru

  Stanford Universiy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: March 22, 2021
• Last Updated: December 19, 2024

Record last verified: 2024-12

Locations

US (1)