18F-DCFPyL PSMA- Versus 18F-NaF-PET Imaging for Detection of Metastatic Prostate Cancer

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Enrolling by invitation

CT.gov ID

NCT03173924

Collaborator

(none)

180

Enrollment

Location

Arm

96.8

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Background:

Prostate cancer is the second leading cause of cancer deaths in American men. Few options exist to create images of this type of cancer. Researchers think an experimental radiotracer called 18F-DCFPyL could find sites of cancer in the body.

Objective:

To see if 18F-DCFPyL can identify sites of prostate cancer in people with the disease.

Eligibility:

People ages 18 and older who have metastatic prostate cancer

Design:

Participants will be screened with:

Blood tests
Physical exam
Medical history

Participants will be assigned to 1 of 2 groups based on their PSA.

Participants will have 18F-DCFPyL injected into a vein. About 2 hours later they will have a whole-body Positron Emission

Tomography/Computed Tomography (PET/CT). For the scan, they will lie on their back on the scanner table while it takes pictures of the body. This lasts about 50 minutes.

On another day, participants will have 18F -NaF injected into a vein. About 1 hour later, they will have a whole-body PET/CT.

Participants will be contacted 1 3 days later for follow-up. They may undergo PET/Magnetic Resonance Imaging (MRI) either after having a 18F-DCFPyL PET/CT, or in place of PET/CT imaging. A tube may be placed in the rectum. More coils may be wrapped around the outside of the pelvis.

If the 18F-DCFPyL PET/CT is positive participants will be encouraged to undergo a biopsy of one of the tumors. The biopsy will be taken through a needle put through the skin into the tumor.

Participants will be followed for 1 year. During this time researchers will collect information about their prostate cancer, such as PSA levels and biopsy results.

About 4-6 months after scanning is completed, participants may have a tumor biopsy. The biopsy will be taken through a needle put through the skin into the tumor.

...

Condition or Disease	Intervention/Treatment	Phase
Metastatic Prostate Cancer Prostatic Neoplasms Prostate Cancer Prostatic Cancer Prostate Neoplasms	Drug: 18F-NaF Drug: 18F-DCFPyL Drug: 18F-FDG	Phase 2

Detailed Description

Background:

The objective of this study is to evaluate a radiolabeled urea-based small molecule inhibitor of prostate-specific membrane antigen (PSMA), [18F] DCFPyL (DCFPyL) PET/CT (or PET/MRI imaging if available) for detection of metastatic prostate cancer

PSMA is a well characterized histological marker of prostate cancer tumor aggressiveness and metastatic potential

Our preliminary first-in-human studies demonstrate high specific uptake of a first generation less avid compound, DCFBC, in metastatic prostate cancer and demonstrated feasibility for prostate cancer metastatic detection.

We propose to assess the ability of DCFPyL PET to detect metastatic prostate cancer by visual qualitative and quantitative SUV analysis. Correlation will be made to sites of suspected bony metastatic disease detected by ultra-sensitive but less specific [18F] Sodium Fluoride (NaF)-PET/CT imaging and all sites of suspected disease detected by [18F] Fluorodeoxyglucose (FDG) for prostate cancer.

Objective:

To compare the diagnostic sensitivity of DCFPyL-PET/CT (or PET/MRI imaging if available) to NaF-PET/CT for detection of prostate cancer bone metastasis based on comparison to reference standard of care conventional imaging modalities (CIM); such as CT and whole body bone scintigraphy incorporating prior and follow-up scans and histopathology when available.

Eligibility:

Histological confirmation of prostate cancer

Age >=18 years old

Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2.

Patients must have either:

Confirmation of prostate cancer with identifiable metastatic disease on at least 1 clinically indicated imaging modality. If there is only soft tissue metastasis, one lesion must measure at least 6 mm or greater. OR
Documented history of metastatic prostate cancer.

Design:

Two Cohort study

Cohort 1: Stable/Decreasing Prostate Specific Antigen (PSA): PSA must be equal to or less than 0.5 ng/mL value of the last PSA obtained (at least one month apart)

Cohort 2: Rising PSA: PSA must be greater than 0.5 ng/mL above the last PSA value obtained on at least two occasions within 1 year

Patients will undergo DCFPyL PET/CT (or PET/MRI), NaF-PET/CT, and FDG PET/CT within 21 days of each other. The order obtained does not matter.

The DCFPyL PET/CT (or PET/MRI) will be compared with the NaF-PET/CT and FDG PET/CT and standard chest/abdomen/pelvis CT.

DCFPyL PET/CT (or PET/MRI) detection of metastatic disease will be assessed by visual qualitative assessment as positive, equivocal, or negative. Sites of equivocal or positive metastatic disease will have a quantitative PET assessment (SUVmax, SUVmean).

A mandatory research biopsy will be performed under image guidance on a suspicious lesion, if feasible.

The patients will be followed yearly for 4 years by chart review, phone-call, email or any other NIH approved platform for PSA relapse and radiologic evidence of metastatic disease. Additional 18F-DCFPyL and 18F-FDG PET/CTs might be performed during the subject s follow up period there has been a considerable change in patient status (progression or response) based on PSA value, symptomatology, bone scan or CT findings.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Evaluation of 18F-DCFPyL PSMA- Versus 18F-NaF-PET Imaging for Detection of Metastatic Prostate Cancer

Actual Study Start Date :

Jun 6, 2017

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Jun 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1/Experimental intervention 18F-DCFPyL is administered to cohorts	Drug: 18F-NaF Baseline IV followed by PET/CT IMAGING Drug: 18F-DCFPyL Baseline IV followed by PET/CT IMAGING. Additional 18F-DCFPyL PET/CTs might be performed during the subject s follow up period if, in the opinion of the referring clinician, there has been a considerable change in patient status (progression or response) based on clinical grounds/PSA value or to help assess changes of standard of care therapy. Drug: 18F-FDG Baseline IV followed by PET/CT IMAGING. Additional 18F-FDG PET/CTs may be obtained per PI discretion within a 21-day window relative to each 18F-DCFPyL PET/CTs.

Arm

Intervention/Treatment

Experimental: 1/Experimental intervention

18F-DCFPyL is administered to cohorts

Drug: 18F-NaF

Baseline IV followed by PET/CT IMAGING

Drug: 18F-DCFPyL

Baseline IV followed by PET/CT IMAGING. Additional 18F-DCFPyL PET/CTs might be performed during the subject s follow up period if, in the opinion of the referring clinician, there has been a considerable change in patient status (progression or response) based on clinical grounds/PSA value or to help assess changes of standard of care therapy.

Drug: 18F-FDG

Baseline IV followed by PET/CT IMAGING. Additional 18F-FDG PET/CTs may be obtained per PI discretion within a 21-day window relative to each 18F-DCFPyL PET/CTs.

Outcome Measures

Primary Outcome Measures

Accuracy of DCFPyL-PET/CT diagnostics [36 months]
Accuracy of DCFPyL-PET/CT diagnostics

Secondary Outcome Measures

PSMA expression in lesion samples from patients with presumed stable disease and actively expanding disease [36 months]
Correlation between PSMA expression and PSA levels
Association between PSA parameters and the number of metastases identified with DCFPyL- PET/CT (or PET/MRI imaging if available). [36 months]
Correlation between PSA parameters and the number of metastases identified with DCFPyL- PET/CT

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

INCLUSION CRITERIA:
Age greater than or equal to 18 years old
Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2.
Ability of subject to understand and the willingness to sign a written informed consent document.
Patients must have confirmation of prostate cancer with identifiable metastatic disease on at least 1 clinically indicated imaging modality. If there is only soft tissue metastasis, one lesion must measure at least 6 mm or greater. OR Documented history of metastatic prostate cancer.
Patients must be co-enrolled on a UOB, GMB or ROB protocol
Histological confirmation of prostate cancer
Patients must be willing to undergo mandatory research biopsy

EXCLUSION CRITERIA:

Subjects for whom participating would significantly delay the scheduled standard of care therapy.
Subjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results.
Subjects with severe claustrophobia unresponsive to oral anxiolytics
Other medical conditions deemed by the principal investigator (or associates) to make the subject unsafe/ineligible for protocol procedures.
Subjects weighing greater than 350 lbs. (weight limit for scanner table), or unable to fit within the imaging gantry
Serum creatinine greater than 2 times the upper limit of normal