Study of PSMA-targeted 18F-DCFPyL PET/CT for the Detection of Clinically Significant Prostate Cancer

Johns Hopkins Medicine

Status and phase: Active, not recruiting; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: 18F-DCFPyL Injection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03471650

J17149

IRB00139990 (Other Identifier)

Details and patient eligibility

About

This is a phase II, single-center, open-label, trial to evaluate the diagnostic accuracy of PSMA-targeted 18F-DCFPyL PET/CT for detecting clinically significant prostate cancer in a screening population.

Full description

This is a phase II, single-center, open-label, trial to evaluate the diagnostic accuracy of PSMA-targeted 18F-DCFPyL PET/CT for detecting clinically significant prostate cancer in a screening population. 150 biopsy-naïve patients with an elevated PSA (2-10 ng/mL) will be enrolled in this study.

Within 28 days of informed consent, patients will undergo an 18F-DCFPyL PET/CT. All scans will be read by a single experienced radiologist who will identify regions of interest (ROI) with discrete radiotracer uptake. The maximum SUV value (SUVmax) of each ROI will be recorded. For patients without a detectable ROI, the mean SUV (SUVmean) of a 1-2 cm volume of the prostate will instead be recorded.

One to 28 days following PET/CT imaging, a systematic 12 to 14 core TRUS-guided prostate biopsy will be performed. Immediately following completion of systematic TRUS biopsies, fusion-targeted biopsies of all PET and/or MRI visible lesions will be performed, taking an additional 2 to 3 cores from each radiographic ROI. All biopsy cores will be assessed for Gleason score and percent cancer involvement.

Enrollment: 150 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥18 years of age
• PSA of 2-10 ng/mL
• Clinical stage T1c-T2a on digital rectal exam
• Elect to undergo TRUS-guided prostate biopsy as part of routine clinical care
• Willingness to sign informed consent and comply with all protocol requirements

Exclusion criteria

• History of prior prostate biopsy
• Administered a radioisotope ≤5 physical half-lives prior to the date of study PET/CT
• Administered IV X-ray contrast medium ≤24 hours prior to the date of study PET/CT
• Administered oral contrast medium ≤120 hours prior to the date of study PET/CT
• Any medical condition or other circumstances that in the opinion of the investigators compromise obtaining reliable data or achieving the study objectives

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

18F-DCFPyL Injection

Experimental group

Description:

A bolus of \~9 mCi (333 MBq) of 18F-DCFPyL will be injected by slow IV push.

Treatment:

Drug: 18F-DCFPyL Injection