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NCT07455903 · ClinicalTrials.gov registry record · Phase 2
Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET/CT
A Phase 2 study, sponsored by Baptist Health South Florida.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT07455903: Recruiting Phase 2 study, sponsored by Baptist Health South Florida.
NCT07455903 is a Phase 2 study that is actively recruiting participants, run by Baptist Health South Florida. The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07455903, a Phase 2 study, is actively recruiting participants, sponsored by Baptist Health South Florida.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study Summary
The purpose of this research study is to test the efficacy of ADT on prostate-specific membrane antigen (PSMA), a marker of prostate cancer, before and after scheduled ADT. Follow up will be 48 months your prostate removal to do a blood test and log if any new or worsening symptoms have occurred as a part of your standard-of-care (SOC).
Primary Outcome
ORR is based on changes in maximum standard uptake value (SUVmax) on PSMA PET/CT imaging pre- and post-ADT. Complete response (CR) is defined as resolution of all PSMA-avid lesions. Partial response (PR) is defined as \>30% decrease in SUVmax. Progressive disease (PD) is defined as \>30% increase in SUVmax or presence of new PSMA-avid lesions. Stable disease (SD) is defined as not meeting criteria for CR, PR, or PD. ORR is defined as the proportion of participants having CR or PR after ADT based
Interventions
- DRUG Relugolix
- DRUG Bicalutamide
- DRUG Degarelix
- DRUG Leuprolide
- DRUG Triptorelin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2026-04-23 |
| Est. Completion | 2030-10 |
| Phase | Phase 2 |
What NCT07455903 shows while recruiting
NCT07455903 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 5 interventions - of which Relugolix is the first listed.
NCT07455903 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07455903 about?
NCT07455903 is a clinical study titled "Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET/CT". The purpose of this research study is to test the efficacy of ADT on prostate-specific membrane antigen (PSMA), a marker of prostate cancer, before and after scheduled ADT. Follow up will be 48 months your prostate removal to do a blood test and log if any new or worsening symptoms have occurred as ...
What is the current status of trial NCT07455903?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2026-04-23. Estimated completion is 2030-10.
What interventions are being tested in trial NCT07455903?
The interventions under investigation include: Relugolix (DRUG), Bicalutamide (DRUG), Degarelix (DRUG), Leuprolide (DRUG), Triptorelin (DRUG).
Who is sponsoring clinical trial NCT07455903?
This trial is sponsored by Baptist Health South Florida, which has 40 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07455903's enrollment target sits among peer trials
50 1195th of 2000 higher than 740 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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