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

Prostate Cancer Clinical Trial

Official title:

A Phase II Study to Evaluate the Performance of PSMA-targeted 18F-DCFPyL PET/CT for the Detection of Clinically Significant Prostate Cancer in Men With an Elevated PSA

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03471650
• Other study ID #: J17149
• Secondary ID: IRB00139990
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 29, 2018
• Est. completion date: March 7, 2025

Study information

• Verified date: April 2024
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: March 7, 2025
• Est. primary completion date: March 7, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	SKCCC	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Progenics Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of 18F-DCFPyL PET/CT to detect clinically significant prostate cancer on prostate biopsy relative to serum prostate specific antigen (PSA)	Measure the diagnostic accuracy of 18F-DCFPyL PET/CT and compare it with serum PSA for detecting clinically significant prostate cancer on prostate biopsy	4 years
Secondary	Sensitivity of 18F-DCFPyL PET/CT relative to PSA	Measure the diagnostic accuracy of 18F-DCFPyL PET/CT relative to serum PSA for detecting clinically significant prostate cancer as defined by the following alternative definitions: Gleason score =4+3=7; Gleason score =3+4 or >50% involvement of =1 core with Gleason score =3+3=6 prostate cancer; Gleason score =3+4 or >70% involvement of =1 core with Gleason score =3+3=6 prostate cancer; Gleason score =3+4=7, or >2 cores with Gleason score =3+3=6, or >50% involvement of =1 core with Gleason score =3+3=6 prostate cancer.	4 years
Secondary	Sensitivity of 18F-DCFPyL PET/CT for detecting clinically significant prostate cancer relative to mpMRI	Measure the diagnostic accuracy of 18F-DCFPyL PET/CT relative to mpMRI for detecting clinically significant prostate cancer by the various tested definitions	4 years
Secondary	Sensitivity and diagnostic accuracy of 18F-DCFPyL PET/CT relative to the phi blood test for detecting clinically significant prostate cancer by the various tested definitions	Measure the diagnostic accuracy of 18F-DCFPyL PET/CT relative to the phi blood test for detecting clinically significant prostate cancer by the various tested definitions	4 years