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

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

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.

Study Overview

• Status: Completed
• Conditions: Metastatic Prostate Cancer
• Intervention / Treatment: Drug: 18F-DCFPyL Injection; Drug: 18F-NaF

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Histological confirmation of prostate cancer
2. 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
3. Rising PSA on two observations taken at least 1 week apart
4. Adequate peripheral venous access or available central venous catheter access for radiopharmaceutical administration
5. Patient can remain on androgen deprivation therapy if on the same regimen prior to documentation of progressive metastatic disease
6. Patient cannot start a new therapy for prostate cancer prior to study radiopharmaceutical imaging
7. 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
8. 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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 years

Collaborators and Investigators

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Martin Pomper, MD,PhD, Department of Nuclear Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2016
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: May 12, 2016
• First Submitted That Met QC Criteria: April 6, 2018
• First Posted (Actual): April 13, 2018

Study Record Updates

• Last Update Posted (Actual): May 7, 2020
• Last Update Submitted That Met QC Criteria: May 5, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: J1559; IRB00065679 (Other Identifier: JHM IRB); 1U01CA183031-01A1 (U.S. NIH Grant/Contract)