Clinical trial NCT03471650: Study of PSMA-targeted 18F-DCFPyL PET/CT for the Detection of Clinically Significant Prostate Cancer
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: J17149
PSMA
18F-DCFPyL PET/CT
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: Progenics Pharmaceuticals, Inc.
First posted: 2018-03-20
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Sensitivity of 18F-DCFPyL PET/CT to detect clinically significant prostate cancer on prostate biopsy relative to serum prostate specific antigen (PSA)
timeFrame: 4 years
Secondary outcomes:
measure: Sensitivity of 18F-DCFPyL PET/CT relative to PSA
timeFrame: 4 years
measure: Sensitivity of 18F-DCFPyL PET/CT for detecting clinically significant prostate cancer relative to mpMRI
timeFrame: 4 years
measure: 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
timeFrame: 4 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: SKCCC
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Mohamad Allaf, MD
role: PRINCIPAL_INVESTIGATOR
References: