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

Primary Purpose

Metastatic Prostate Cancer

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

18F-DCFPyL Injection

18F-NaF

About this trial

This is an interventional diagnostic trial for Metastatic Prostate Cancer

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)MaleDoes not accept 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.

Sites / Locations

Johns Hopkins University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F-DCFPyL Injection & 18F-NaF

Arm Description

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

Outcomes

Primary Outcome Measures

Comparison of DCFPyL- PET/CT (or PET/MRI imaging) to NaF-PET/CT

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

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.

Full Information

NCT ID

NCT03497377

First Posted

May 12, 2016

Last Updated

May 5, 2020

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT03497377

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

May 16, 2016 (Actual)

Primary Completion Date

April 2020 (Actual)

Study Completion Date

April 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Prostate Cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

18F-DCFPyL Injection & 18F-NaF

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

18F-DCFPyL Injection

Intervention Type

Drug

Intervention Name(s)

18F-NaF

Primary Outcome Measure Information:

Title

Comparison of DCFPyL- PET/CT (or PET/MRI imaging) to NaF-PET/CT

Description

Compare the diagnostic accuracy during visit 2 18F-DCFPyL imaging and visit 3 NaF imaging

Time Frame

4 years

Secondary Outcome Measure Information:

Title

Estimation of new or progressive metastatic lesions found on NaF and 18F-DCFPyL

Description

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.

Time Frame

4 years

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martin Pomper, MD,PhD

Organizational Affiliation

Department of Nuclear Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Johns Hopkins University

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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