NCT03495427 is a Phase 2/Phase 3 clinical trial of F-DCFPyL Injection in Prostate Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

Who is sponsoring NCT03495427?

NCT03495427 is sponsored by H. Lee Moffitt Cancer Center and Research Institute.

What drugs are being tested in NCT03495427?

Interventions in NCT03495427: F-DCFPyL Injection, PSMA PET.

What condition does NCT03495427 study?

NCT03495427 studies Prostate Cancer, Recurrent Prostate Cancer.

Is NCT03495427 still recruiting?

NCT03495427 is currently recruiting now. Last updated 26 February 2026.

Last reviewed 2026-02-26 · How we verify

NCT03495427

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

The Utility of PSMA-PET Imaging for Detecting Early Metastatic Prostate Cancer in Men With High GC Decipher® Test Scores: A Sub-aim of the VANDAAM Study (MCC #18523)

Recruiting now Phase 2/Phase 3 Last updated 26 February 2026

What this trial tests

Phase 2/Phase 3 trial testing F-DCFPyL Injection in Prostate Cancer in 60 participants. Currently enrolling.

Timeline

18 December 2019

Primary endpoint
1 February 2029

1 May 2029

Quick facts

Lead sponsor	H. Lee Moffitt Cancer Center and Research Institute
Phase	Phase 2/Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	60
Start date	18 December 2019
Primary completion	1 February 2029
Estimated completion	1 May 2029
Sites	1 location across United States

Drugs / interventions tested

F-DCFPyL Injection — full drug profile →
PSMA PET

Conditions studied

Prostate Cancer — all drugs for Prostate Cancer →
Recurrent Prostate Cancer — all drugs for Recurrent Prostate Cancer →

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Who can join

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

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Concordance (AUC) Between High Tumor GC Risk Score and Positive PSMA-PET Imaging Findings
Time frame: Up to 5 years
To estimate the concordance between tumor GC risk score and early metastatic disease using PSMA-PET imaging.

Sponsor's own description

This study will enroll 60 patients previously enrolled to MCC#18523, "A Validation Study on the Impact of Decipher® Testing on Treatment Recommendations in African-American and Non-African American Men with Prostate Cancer: (VANDAAM)" that had high risk Decipher test results (Decipher score \>0.45). Patients with a high genomic classifier (GC) score at diagnosis will be approached for formal consenting for PSMA-PET imaging at 2 years post treatment.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Racial disparity in prostate cancer: an outlook in genetic and molecular landscape.
Kaushal JB, Raut P, Muniyan S, Siddiqui JA, et al · · 2024 · cited 4× · PMID 38902476 · DOI 10.1007/s10555-024-10193-8

Verify or expand the search:

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 H. Lee Moffitt Cancer Center and Research Institute trials

Trials by the same sponsor.

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NCT07222995 — Hybrid Effectiveness-Implementation Trial to Integrate Precision Skin Cancer Risk Feedback in FQHCs · NA · recruiting
NCT06047977 — Tumor Infiltrating Lymphocyte Therapy for Pediatric High Risk Solid Tumors · Phase 1 · recruiting
NCT06121180 — Study of Cemiplimab Plus Ziv-Aflibercept for Subjects With Metastatic Uveal Melanoma · Phase 2 · recruiting
NCT06193486 — Autologous Gamma Delta T Cells to Target Prostate Stem Cell Antigen in mCRPC · Phase 1 · 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 NCT03495427 (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 H. Lee Moffitt Cancer Center and Research Institute
Last refreshed: 26 February 2026

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/NCT03495427.

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