Molecular Imaging of Prostate Cancer Using Radiofluorinated PSMA Ligand

May 4, 2022 updated by: Dinko Franceschi, Stony Brook University
Eligible patients have prostate cancer that was treated with surgery or radiation therapy for localized disease and there is evidence of biochemical recurrence and/or metastases on conventional imaging.The objective of this study is to assess the performance in detection of prostate cancer of a new positron emission tomography (PET) radiotracer for prostate cancer ([18F]-DCFPyl) combined with magnetic resonance imaging (MRI). Results of tracer uptake and MRI image features as whole body PET/MRI and dedicated pelvic/prostate PET/MRI, alone and together, will be correlated and compared to detection of lesions on conventional imaging modalities. Additionally, if the patient undergoes a biopsy as standard of care, image features will correlate directly with histopathological findings.Validation of this radiotracer can potentially lead to its use as a standard of care for future imaging and improve diagnosis and treatment guidance.This drug is not approved by the Food and Drug Administration (FDA) and is therefore considered experimental.There will be 20 subjects enrolled in this study; all of these patients will be enrolled at Stony Brook University Medical Center.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study objective is to assess the performance of [18F]-DCFPyl PET with whole-body MRI and multiparametric pelvic/prostate MRI for PCa detection in men with recurrence as determined by biochemical PSA level or evidence on CIM. Results of tracer uptake and MRI image features on whole body PET/MRI and dedicated pelvic/prostate PET/MRI, alone and together, will be correlated and compared to detection of lesions on CIM that usually includes bone scan (BS) and CT scan of the abdomen and pelvis, or PET imaging with F-18 Fluciclovine. In addition, in patients who undergo a biopsy when performed as standard of care, image features will correlate directly with histopathological findings on lesion biopsy to directly demonstrate that 'radiotracer and/or MRI positive' lesions contain tumor cells.

To test the hypothesis, this study is being proposed using the [18F]-DCFPyL PET tracer for the detection of PCa in patients with biochemical recurrence or evidence on CIM. The [18F]-DCFPyL PET tracer will be provided by the company Progenics Pharmaceuticals, Inc. (New York, New York) and conducted under an investigational new drug (IND) approval received by Stony Brook University.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • Stony Brook, New York, United States, 11794-7263
        • Stony Brook University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • subject has prostate cancer treated with surgery, radiation therapy and/or chemotherapy for localized disease
  • subject has biochemical recurrence defined in postsurgical patients as a PSA value = > 0.2 ng/mL followed by a subsequent confirmatory PSA value = >0.2 ng/mL according to the American Urological Association (AUA) guidelines, or three consecutive rises above the nadir in patients following radiation therapy according to the American Society for Radiation Therapy and Oncology (ASTRO).
  • in most cases, it will be required that the patient has had a prior CIM scan (such as a BS, MRI, CT or PET with F-18 Fluciclovine) performed before enrollment in this study; the only exception would be if the PSA level of the patient is remarkably high indicating apparent recurrence.

Exclusion Criteria:

  • less than 18 years of age (prostate cancer is not prevalent in the pediatric population);
  • any contraindications to MRI imaging such as electrical implants, cardiac pacemakers or perfusion pumps;
  • ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or ferromagnetic objects such as jewelry or metal clips in clothing;
  • is unable to lie comfortably on a bed inside the scanner for 60 minutes as assessed by physical examination and medical history (e.g. back pain, arthritis);
  • if they have had treatment with investigational drug within 30 days prior to trial enrollment;
  • if they had administration of another radioisotope within five physical half-lives of trial enrollment;
  • if they had radiation or chemotherapy within 4 weeks prior to trial enrollment;

Eligibility will be determined by a screening interview. All subjects recruited for the study will be able to withdraw from the study at any time.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
To assess the performance of [18F]-DCFPyl PET with whole-body MRI and multiparametric pelvic/prostate MRI for PCa detection in men with recurrence as determined by biochemical PSA level or evidence on CIM. Results of tracer uptake and MRI image features on whole body PET/MRI and dedicated pelvic/prostate PET/MRI, alone and together, will be correlated and compared to detection of lesions on CIM that usually includes bone scan (BS) and CT scan of the abdomen and pelvis, or PET imaging with F-18 Fluciclovine.In addition, in patients who undergo biopsy when performed as standard of care, we will correlate image features directly with histopathological findings on lesion biopsy to directly demonstrate that 'radiotracer and/or MRI positive' lesions contain tumor cells.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of PET PSMA and Conventional Imaging
Time Frame: Within 1 year from the PET Imaging study
Compare [18F]DCFPyL PET imaging combined with whole body magnetic resonance imaging (MRI) and multiparametric pelvic/prostate MRI to conventional imaging modalities (CIM)--such as 99mTc-methylene diphosphonate bone scan (BS) and contrast-enhanced CT (CECT) of the abdomen and pelvis, or a newly approved PET imaging agent F-18 Fluciclovine, for the localization and determination of extent of recurrent/metastatic disease in patients with biochemical recurrence of prostate cancer or evidence of recurrence on CIM.
Within 1 year from the PET Imaging study
Sensitivity and Specificity of PET/MRI PSMA in biochemical recurrence
Time Frame: Within 1 year from the PET Imaging study
Determine the sensitivity and specificity of [18F]-DCFPyL PET/MRI for extent of recurrent/metastatic disease in patients with biochemical recurrence.
Within 1 year from the PET Imaging study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Dinko Franceschi, MD, Stony Brook Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2019

Primary Completion (Actual)

October 15, 2021

Study Completion (Actual)

October 15, 2021

Study Registration Dates

First Submitted

February 10, 2020

First Submitted That Met QC Criteria

February 10, 2020

First Posted (Actual)

February 12, 2020

Study Record Updates

Last Update Posted (Actual)

May 5, 2022

Last Update Submitted That Met QC Criteria

May 4, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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