PSMA-based 18F-DCFPyL PET/CT and PET/MRI Pilot Studies in Prostate Cancer

Prostate Cancer Clinical Trial

Official title: PSMA-based 18F-DCFPyL PET/CT and PET/MRI Pilot Studies in Prostate Cancer

Status Recruiting

Clinical Trial Summary

The overall goal of this research is to validate and develop a non-invasive imaging biomarker of prostate cancer detection, progression, and recurrence. Development of such a biomarker may be useful to differentiate indolent from aggressive prostate cancer phenotypes allowing for selection of an appropriate risk adaptive therapy.

Clinical Trial Description

The investigators propose to evaluate a novel second-generation low-molecular-weight prostate specific membrane antigen (PSMA)-based positron emission tomography (PET) agent, 18F-DCFPyL, for detection of primary and metastatic prostate cancer. 18F-DCFPyL PET demonstrates very high tumor-to-background and tumor specific uptake which may allow for a more sensitive and accurate method for detection of early tumor recurrence and metastatic disease as compared to current PET radiotracers and current standard-of-care imaging including 99mTc-methylene diphosphonate bone scintigraphy (bone scan), contrast-enhanced computed tomography (CT) and magnetic resonance imaging (MRI).

Primary Objectives: The investigators propose to evaluate this PET agent for four different prostate cancer clinical scenarios.

1. detection of clinically significant high-grade prostate cancer and initial staging

2. detection of sites of recurrence in the setting of biochemical recurrence after definitive prostatectomy

3. detection of advanced androgen-resistant metastatic prostate cancer, and

4. detection of clinically significant prostate cancer in very low to intermediate risk primary prostate cancer

Secondary Objectives:

• Evaluate the performance of 18F-DCFPyL PET and MRI whole body DWI for detection of local-nodal and distant metastatic disease on initial staging compared to conventional imaging modalities (CT and bone scintigraphy).

• Correlate 18F-DCFPyL PET standardized-uptake values (SUV) and MRI parameters with PSMA expression by prostatectomy pathology IHC.

• Evaluate the specificity of 18F-DCFPyL PET for differentiating primary prostate cancer versus non-malignant prostate lesions (BPH, prostatitis).

• Comparison of whole body low-dose CT and whole body MRI derived PET SUV-quantitation.

• Evaluate the performance of dedicated pelvic 18F-DCFPyL PET/MRI with dynamic PET acquisition and multi-parametric MRI for differentiation of urine versus recurrent malignancy in the prostatectomy bed.

• Evaluate the contribution of whole body MRI DWI obtained from PET/MRI to improve the diagnostic performance of 18F-DCFPyL PET/CT and PET/MRI for metastatic prostate cancer lesion detection.

• Assess the quantitative accuracy of PET-derived standardized uptake value (SUV)-based parameters in 18F-DCFPyL PET obtained from PET/MRI versus PET/CT.

• Assess the quantitative reproducibility of 18F-DCFPyL PET/CT derived-SUV values in normal organ and metastatic tumor lesions.

• Evaluate the ability of 18F-DCFPyL PET to improve detection of clinically significant primary prostate cancer in men with very low to intermediate risk prostate cancer under active surveillance or watchful waiting.

Update: As of July 2022 verification, the investigators are no longer enrolling into sub-studies 1 and 2. ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostate Neoplasm
• Prostatic Neoplasms

• NCT number: NCT03232164
• Study type: Interventional
• Source: University of Wisconsin, Madison
• Contact: Gemma Gliori
• Phone: (608) 262-7269
• Email: ggliori@uwhealth.org
• Status: Recruiting
• Phase: Early Phase 1
• Start date: February 2, 2017
• Completion date: December 2024