Clinical trial NCT04266392: Molecular Imaging of Prostate Cancer Using Radiofluorinated PSMA Ligand
Official title: Molecular Imaging of Prostate Cancer Using Radiofluorinated PSMA Ligand
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Prostate Cancer
Lead sponsor: Stony Brook University
Sponsor class: OTHER
Collaborators: name: Progenics Pharmaceuticals, Inc.
First posted: 2020-02-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility 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.

Primary outcomes:
measure: Comparison of PET PSMA and Conventional Imaging
timeFrame: Within 1 year from the PET Imaging study
measure: Sensitivity and Specificity of PET/MRI PSMA in biochemical recurrence
timeFrame: Within 1 year from the PET Imaging study
Secondary outcomes:
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
Study officials:
affiliation: Stony Brook Cancer Center
name: Dinko Franceschi, MD
role: PRINCIPAL_INVESTIGATOR
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