NCT03976843

Prostate Specific Membrane Antigen (PMSA)-Based PET Imaging of High Risk Prostate Cancer

Active, enrolled Phase 2 Last updated 6 April 2026

What this trial tests

Phase 2 trial testing 18F-DCFPyL in Prostate Cancer in 175 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

4 December 2019

Primary endpoint
19 November 2027

19 November 2027

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	175
Start date	4 December 2019
Primary completion	19 November 2027
Estimated completion	19 November 2027
Sites	6 locations across United States

Drugs / interventions tested

• 18F-DCFPyL — full drug profile →

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

National Cancer Institute (NCI)

Who can join

Adults 18 to 99, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

People with prostate cancer usually have their cancer imaged with a CT scan and bone scan. They then have their prostate gland removed. Researchers want to test a scan that might predict if prostate cancer will return after this surgery.

Objective:

To test if a PET/CT scan before the prostate gland is removed can predict if prostate cancer will return. Also, to test if this approach is better or worse than the usual approach for prostate cancer.

Eligibility:

Men ages 18 and older with prostate cancer that appears to be contained within the prostate but is at risk of having spread

Design:

Participants will be screened with:

* Medical history
* Blood tests
* CT and MRI scans: Participants will lie in a machine. The machine will take pictures of the body.
* Bone scan

Participants will have a radiotracer injected into a vein. They will have a PET/CT scan of their whole body 60-90 minutes later. During the scan, they will lie on their back and stay still.

Within 60 days after the scan, participants will have surgery. This will remove the prostate gland and lymph nodes around it. Some tissue will be used for genetic testing.

If the PET/CT scan suggests the cancer has spread, participants may need to have another biopsy within 60 days after the scan.

After surgery, participants will have follow-up visits for 5 years. They will have 5 visits the first year and 2 the second. Then they will have visits once a year.

If participants cancer returns, they will have repeat PET/CT scans.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. PSMA Theranostics: Review of the Current Status of PSMA-Targeted Imaging and Radioligand Therapy.
   Jones W, Griffiths K, Barata PC, Paller CJ. · · 2020 · cited 78× · PMID 32466595 · DOI 10.3390/cancers12061367
2. Incorporating PSMA-Targeting Theranostics Into Personalized Prostate Cancer Treatment: a Multidisciplinary Perspective.
   Ng TSC, Gao X, Salari K, Zlatev DV, et al · · 2021 · cited 4× · PMID 34395293 · DOI 10.3389/fonc.2021.722277