NCT03471650Active, not recruitingPhase 2
Study of PSMA-targeted 18F-DCFPyL PET/CT for the Detection of Clinically Significant Prostate Cancer
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
Source: ClinicalTrials.gov · Last updated 30 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 2 Mar 2018
- Start date
- 29 Mar 2018
- Primary completion date
- 7 Mar 2028
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Diseases
- Prostate cancer
- NCT number
- NCT03471650
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 150
- From 29 Mar 2018 to the primary completion date, 7 Mar 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Any medical condition or other circumstances that in the opinion of the investigators compromise obtaining reliable data or achieving the study objectives
Who the study is looking for
- ≥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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| SKCCC Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.