Molecular Imaging of Prostate Cancer Using Radiofluorinated PSMA Ligand

Early Phase 1

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: [18F]-DCFPyl Ligand

• Registration Number: NCT04266392
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2019-12-16
• Study First Submitted: 2020-02-10
• Study First Submitted QC: 2020-02-10
• Study First Posted: 2020-02-12
• Primary Completion: 2021-10-15
• Study Completion: 2021-10-15
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-04
• Last Update Posted: 2022-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	[18F]-DCFPyl Ligand	-

Primary Outcome Measures

Name	Time	Method
Comparison of PET PSMA and Conventional Imaging	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.
Sensitivity and Specificity of PET/MRI PSMA in biochemical recurrence	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.

Trial Locations

Locations (1)

Stony Brook University; 🇺🇸 Stony Brook, New York, United States