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Molecular Imaging of Prostate Cancer Using Radiofluorinated PSMA Ligand

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04266392
Recruitment Status : Recruiting
First Posted : February 12, 2020
Last Update Posted : February 12, 2020
Sponsor:
Collaborator:
Progenics Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Dinko Franceschi, Stony Brook University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: [18F]-DCFPyl Ligand Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Molecular Imaging of Prostate Cancer Using Radiofluorinated PSMA Ligand
Actual Study Start Date : December 16, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1 Drug: [18F]-DCFPyl Ligand
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.




Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04266392


Contacts
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Contact: Audrey Anderson 631-638-0829 Audrey.Anderson@stonybrookmedicine.edu

Locations
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United States, New York
Stony Brook University Recruiting
Stony Brook, New York, United States, 11794-7263
Contact: Dinko Franceschi, MD    631-444-2480    Dinko.Franceschi@stonybrookmedicine.edu   
Sponsors and Collaborators
Stony Brook University
Progenics Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Dinko Franceschi, MD Stony Brook Cancer Center

Publications:

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Responsible Party: Dinko Franceschi, Clinical Associate Professor, Stony Brook University
ClinicalTrials.gov Identifier: NCT04266392    
Other Study ID Numbers: 889520
First Posted: February 12, 2020    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases