NCT04266392

Molecular Imaging of Prostate Cancer Using Radiofluorinated PSMA Ligand

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Stony Brook University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-12-16
• Primary completion: 2021-10-15
• Completion: 2021-10-15
• First posted: 2020-02-12
• Last updated: 2022-05-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study