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NCT03495427 · ClinicalTrials.gov registry record · Phase 2
PSMA-PET Imaging for Detecting Early Metastatic Prostate Cancer in Men w/ High Decipher Test Scores
A Phase 2 study of Prostate Cancer and Recurrent Prostate Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT03495427: Recruiting Phase 2 study of Prostate Cancer and Recurrent Prostate Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT03495427 is a Phase 2 study of Prostate Cancer and Recurrent Prostate Cancer that is actively recruiting participants, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 60 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03495427, a Phase 2 study of Prostate Cancer and Recurrent Prostate Cancer, is actively recruiting participants, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
To estimate the concordance between tumor GC risk score and early metastatic disease using PSMA-PET imaging.
Conditions Studied
Interventions
- DRUG F-DCFPyL Injection
- DIAGNOSTIC_TEST PSMA PET
Study Locations (1)
Florida
- H. Lee Moffitt Cancer Center and Research Institute - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2019-12-18 |
| Est. Completion | 2029-05 |
| Phase | Phase 2 |
What NCT03495427 shows while recruiting
NCT03495427 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (90% lower).
The record links to 2 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which F-DCFPyL Injection is the first listed.
NCT03495427 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT03495427 about?
NCT03495427 is a clinical study titled "PSMA-PET Imaging for Detecting Early Metastatic Prostate Cancer in Men w/ High Decipher Test Scores". 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)....
What is the current status of trial NCT03495427?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2019-12-18. Estimated completion is 2029-05.
What conditions does trial NCT03495427 study?
This clinical trial studies the following conditions: Prostate Cancer, Recurrent Prostate Cancer.
What interventions are being tested in trial NCT03495427?
The interventions under investigation include: F-DCFPyL Injection (DRUG), PSMA PET (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03495427?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03495427 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03495427's enrollment target sits among peer trials
60 421st of 735 higher than 293 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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