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

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Other)

Overall Status

Completed

CT.gov ID

NCT03497377

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arm

46.5

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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. 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. Investigators 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 metastatic disease detected by ultra sensitive but less specific [18F]Sodium Fluoride (NaF)-PET/CT imaging for prostate cancer.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Prostate Cancer	Drug: 18F-DCFPyL Injection Drug: 18F-NaF	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

25 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 :

May 16, 2016

Actual Primary Completion Date :

Apr 1, 2020

Actual Study Completion Date :

Apr 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 18F-DCFPyL Injection & 18F-NaF A bolus of ~9 mCi (333 MBq) of 18F-DCFPyL injected by slow IV push. A dose of 5 mCi 18F-NaF is injected through the IV and followed by at least 10 ml of saline to flush the IV line of the remaining dose	Drug: 18F-DCFPyL Injection Drug: 18F-NaF

Arm

Intervention/Treatment

Experimental: 18F-DCFPyL Injection & 18F-NaF

A bolus of ~9 mCi (333 MBq) of 18F-DCFPyL injected by slow IV push. A dose of 5 mCi 18F-NaF is injected through the IV and followed by at least 10 ml of saline to flush the IV line of the remaining dose

Drug: 18F-DCFPyL Injection

Drug: 18F-NaF

Outcome Measures

Primary Outcome Measures

Comparison of DCFPyL- PET/CT (or PET/MRI imaging) to NaF-PET/CT [4 years]
Compare the diagnostic accuracy during visit 2 18F-DCFPyL imaging and visit 3 NaF imaging

Secondary Outcome Measures

Estimation of new or progressive metastatic lesions found on NaF and 18F-DCFPyL [4 years]
Compare proportion of new or progressive metastatic lesions found on NaF-PET/CT that are DCFPyL- PET/CT (or PET/MRI imaging if available) positive, and vice-versa.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

Histological confirmation of prostate cancer
Radiologic evidence of new or progressive metastatic disease demonstrated on anatomical imaging (CT, MRI, or ultrasound), bone scintigraphy, [18F]Sodium Fluoride PET, and/or [18F]FDG PET
Rising PSA on two observations taken at least 1 week apart
Adequate peripheral venous access or available central venous catheter access for radiopharmaceutical administration
Patient can remain on androgen deprivation therapy if on the same regimen prior to documentation of progressive metastatic disease
Patient cannot start a new therapy for prostate cancer prior to study radiopharmaceutical imaging
Patient is judged by the Investigator to have the initiative and means to be compliant with the protocol and be within geographical proximity to make the required study visits
Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures

Exclusion Criteria:

Patient has been treated with an investigational drug, investigational biologic, or investigational therapeutic device within 14 days prior to study radiotracer administration
Prior radiation therapy, chemotherapy, or androgen-deprivation therapy within 2 weeks prior to study radiotracer administration (Washout is one half-life of the drug or 2 weeks, whichever is longest)
Initiation of new therapy for progressive metastatic disease since radiographic documentation of progression.
Serum creatinine > 3 times the upper limit of normal
Total bilirubin > 3 times the upper limit of normal
Liver Transaminases > 5times the upper limit of normal
Unable to lie flat during or tolerate PET/CT (or PET/MRI imaging if available)
Prior history of any other malignancy within last 2 years, other than skin basal cell carcinoma or superficial bladder cancer.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins University	Baltimore	Maryland	United States	21287

Sponsors and Collaborators

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
National Cancer Institute (NCI)

Investigators

Principal Investigator: Martin Pomper, MD,PhD, Department of Nuclear Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

ClinicalTrials.gov Identifier:

NCT03497377

Other Study ID Numbers:

J1559
IRB00065679
1U01CA183031-01A1

First Posted:

Apr 13, 2018

Last Update Posted:

May 7, 2020

Last Verified:

May 1, 2020

Additional relevant MeSH terms:

Prostatic Neoplasms

Study Results

No Results Posted as of May 7, 2020