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

NCT ID: NCT04809584

Last Updated: 2024-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

APPROVED_FOR_MARKETING

Study Classification

EXPANDED_ACCESS

Brief Summary

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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

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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.

Conditions

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Prostate Cancer

Interventions

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F18-DCFPyL

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

Intervention Type DRUG

Gadolinium

Contrast agent

Intervention Type DRUG

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

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

Intervention Type PROCEDURE

Other Intervention Names

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motexafin gadolinium

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrei H Iagaru

Role: PRINCIPAL_INVESTIGATOR

Stanford Universiy

Locations

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Stanford University

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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PROS0103

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-58503

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-58503

Identifier Type: -

Identifier Source: org_study_id