NCT03181867

18F-DCFPyL PET/CT in High Risk and Recurrent Prostate Cancer

ENROLLING BY INVITATION Phase 2 Last updated 21 January 2026

What this trial tests

Phase 2 trial testing 18F-DCFPyL in Prostate Neoplasms in 800 participants. Enrolling by invitation.

Timeline

3 August 2017

Primary endpoint
31 December 2029

31 December 2030

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 2
Status	ENROLLING BY INVITATION
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	800
Start date	3 August 2017
Primary completion	31 December 2029
Estimated completion	31 December 2030
Sites	1 location across United States

Drugs / interventions tested

• 18F-DCFPyL — full drug profile →
• 18F-FDG — full drug profile →
• PSMA-11 — full drug profile →

Conditions studied

• Prostate Neoplasms — all drugs for Prostate Neoplasms →
• Prostatic Cancer — all drugs for Prostatic Cancer →
• Prostate Cancer — all drugs for Prostate Cancer →
• Cancer Of Prostate — all drugs for Cancer Of Prostate →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, male only, with Prostate Neoplasms or Prostatic Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

Prostate cancer is the second leading cause of cancer deaths in American men. When prostate cancer is confined to the prostate there is a high chance of cure. However, it is outside the prostate or comes back after treatment, additional therapy may be needed. Current methods of imaging prostate cancer are limited. Researchers want to see if a radiotracer called 18F-DCFPyL can identify prostate cancer in patients who have a high risk of cancer spreading outside the prostate or who have signs of recurrent cancer after treatment.

Objectives:

To see if the radiotracer 18F-DCFyL can help identify prostate cancer in the body before or after therapy.

Eligibility:

Men ages 18 and older who have prostate cancer that has been newly diagnosed, or has relapsed after radiation or surgery

Design:

Participants will be divided into 2 groups.

* Group 1 will be men with cancer that has been newly diagnosed as high risk by their doctor who are scheduled to have prostate removal surgery or undergo biopsy before radiation therapy.
* Group 2 will be men who have presumed prostate cancer relapse after prostate removal surgery or radiation therapy.

Both groups will have scans taken. Participants will lie still on a table in a machine that takes pictures of their body. 18F-DCFyL will be injected by intravenous (IV) line.

Participants will be contacted for follow-up after scans.

Participants in Group 1 may have surgery to remove their prostate gland or a biopsy to remove some prostate tissue. This procedure will be standard of care and is not a part of this study. They will also have an extra MRI scan of their prostate. For this, a tube, called an endorectal coil, will be placed in their rectum. Other tubes may be wrapped around the inside of their pelvis. A contrast agent will be given by IV.

Participants in Group 2 may also undergo an MRI of the pelvis and may have a biopsy of abnormalities found on the 18F-DCFyL scan.

Participants will have data about their prostate cancer collected for up to 1 year.

Publications & conference data

8 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. ¹⁸F-DCFPyL PET/CT Imaging in Patients with Biochemically Recurrent Prostate Cancer After Primary Local Therapy.
   Mena E, Lindenberg ML, Turkbey IB, Shih JH, et al · · 2020 · cited 43× · PMID 31676732 · DOI 10.2967/jnumed.119.234799
3. Evaluating Biochemically Recurrent Prostate Cancer: Histologic Validation of <sup>18</sup>F-DCFPyL PET/CT with Comparison to Multiparametric MRI.
   Lindenberg L, Mena E, Turkbey B, Shih JH, et al · · 2020 · cited 26× · PMID 32633674 · DOI 10.1148/radiol.2020192018
4. Prospective Evaluation of <sup>18</sup>F-DCFPyL PET/CT in Detection of High-Risk Localized Prostate Cancer: Comparison With mpMRI.
   Gaur S, Mena E, Harmon SA, Lindenberg ML, et al · · 2020 · cited 22× · PMID 32755168 · DOI 10.2214/ajr.19.22042
5. Predictors of ¹⁸F-DCFPyL PET/CT Positivity in Patients with Biochemical Recurrence of Prostate Cancer After Local Therapy.
   Mena E, Rowe SP, Shih JH, Lindenberg L, et al · · 2022 · cited 18× · PMID 34916246 · DOI 10.2967/jnumed.121.262347
6. Predicting Outcomes of Indeterminate Bone Lesions on <sup>18</sup>F-DCFPyL PSMA PET/CT Scans in the Setting of High-Risk Primary or Recurrent Prostate Cancer.
   Phelps TE, Harmon SA, Mena E, Lindenberg L, et al · · 2023 · cited 17× · PMID 36265908 · DOI 10.2967/jnumed.122.264334
7. PSMA expression in the Hi-Myc model; extended utility of a representative model of prostate adenocarcinoma for biological insight and as a drug discovery tool.
   Simons BW, Turtle NF, Ulmert DH, Abou DS, et al · · 2019 · cited 15× · PMID 30656716 · DOI 10.1002/pros.23770
8. Pattern of failure in prostate cancer previously treated with radical prostatectomy and post-operative radiotherapy: a secondary analysis of two prospective studies using novel molecular imaging techniques.
   Rowe LS, Harmon S, Horn A, Shankavaram U, et al · · 2021 · cited 12× · PMID 33568190 · DOI 10.1186/s13014-020-01733-x