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

NCT ID: NCT03471650

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-29
• Study Completion Date: 2027-03-07

Brief Summary

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.

Detailed 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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

18F-DCFPyL Injection

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

Group Type: EXPERIMENTAL

18F-DCFPyL Injection

Intervention Type: DRUG

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

Interventions

18F-DCFPyL Injection

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

Intervention Type: DRUG

Other Intervention Names

PyL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Progenics Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mohamad Allaf, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

SKCCC

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

IRB00139990

Identifier Type: OTHER

Identifier Source: secondary_id

J17149

Identifier Type: -

Identifier Source: org_study_id