NCT03793543 is a Phase 1 clinical trial of 18F-DCFPyL Injection in Prostate Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

Who is sponsoring NCT03793543?

NCT03793543 is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

What drugs are being tested in NCT03793543?

Interventions in NCT03793543: 18F-DCFPyL Injection.

What condition does NCT03793543 study?

NCT03793543 studies Prostate Cancer.

Is NCT03793543 still recruiting?

NCT03793543 is currently completed. Last updated 15 December 2021.

Last reviewed 2021-12-15 · How we verify

NCT03793543

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Test-Retest Reproducibility of 18F-DCFPyL PET/CT in the Evaluation of Patients With Metastatic Prostate Cancer

Completed Phase 1 Last updated 15 December 2021

What this trial tests

Phase 1 trial testing 18F-DCFPyL Injection in Prostate Cancer in 23 participants. Completed in 15 October 2021.

Timeline

27 March 2019

Primary endpoint
6 March 2020

15 October 2021

Quick facts

Lead sponsor	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	23
Start date	27 March 2019
Primary completion	6 March 2020
Estimated completion	15 October 2021
Sites	1 location across United States

Drugs / interventions tested

18F-DCFPyL Injection

Conditions studied

Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — full company profile →

Who can join

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

Sponsor's own description

In this study, the investigators intend to validate 18F-DCFPyL test-retest reproducibility in metastatic lesions, in order to investigate whether it serves as a reliable response assessment tool, both to interpret existing studies and to design future longitudinal trials.

Publications & conference data

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

High SUVs Have More Robust Repeatability in Patients with Metastatic Prostate Cancer: Results from a Prospective Test-Retest Cohort Imaged with 18F-DCFPyL.
Werner RA, Habacha B, Lütje S, Bundschuh L, et al · · 2022 · cited 10× · PMID 35283693 · DOI 10.1155/2022/7056983
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
Test-retest repeatability of organ uptake on PSMA-targeted 18 F-DCFPyL PET/CT in patients with prostate cancer.
Werner RA, Lütje S, Habacha B, Bundschuh L, et al · · 2023 · cited 2× · PMID 37211963 · DOI 10.1002/pros.24577
Repeatability of Semi-Quantitative and Volumetric Features from Artificial-Intelligence-Guided Lesion Segmentation on 18F-DCFPyL PSMA-PET/CT Images: Results from a Test-Retest Cohort.
Islam MZ, Perk TG, Weisman A, Markowski MC, et al · · 2026 · PMID 41893833 · DOI 10.3390/tomography12030038

Verify or expand the search:

Other trials of 18F-DCFPyL Injection

Trials testing the same drug.

NCT03800784 — Study of 18F-DCFPyL PET/CT Imaging in Patients With Prostate Cancer · Phase 2, PHASE3 · withdrawn
NCT03471650 — Study of PSMA-targeted 18F-DCFPyL PET/CT for the Detection of Clinically Significant Prostate Cancer · Phase 2 · active not recruiting
NCT03542773 — Targeted Imaging of Glutamate Carboxypeptidase II With DCFPyL-PET · Phase 1 · completed

Other recruiting trials for Prostate Cancer

Currently open trials in the same condition.

NCT06960798 — Characterizing the Genomic Landscape of Prostate Cancer in Native American Populations (NAT-Geno) · recruiting
NCT07237269 — Abi/Pred + ADT vs ADT in PSMA-Positive, Conventionally Node-Negative Prostate Cancer · Phase 2 · recruiting
NCT07234981 — PSMA-PET Guided De-escalation of Salvage Radiation Treatment in Recurrent Prostate Cancer · Phase 2 · recruiting
NCT07027124 — Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Ris · Phase 2 · recruiting
NCT07426094 — PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate · Phase 2, PHASE3 · recruiting

Other Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins trials

Trials by the same sponsor.

NCT07424222 — Ruxolitinib for Immune Effector Cell Associated Hemophagocytic Lymphohistiocytosis-like Syndrome (RISE) · Phase 1 · not yet recruiting
NCT06210854 — Assessing Administration of pBI-11 Via Electroporation for the Treatment of Patients With HPV16/18+ · Phase 2 · not yet recruiting
NCT07360119 — Total Pancreatectomy With Islet Autotransplantation (TPIAT) for High-Risk Patients With Pancreatic Tumors · NA · not yet recruiting
NCT07140315 — DK222 Study at Hopkins · Phase 1 · recruiting
NCT07071155 — Momelotinib in Combination With Hypomethylating Agent for Chronic Phase Myelodysplastic Syndromes/Myeloproliferative Ove · EARLY_PHASE1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03793543 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last refreshed: 15 December 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03793543.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing