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NCT07593079 · ClinicalTrials.gov registry record · Phase 2
Prostate Specific Membrane Antigen (PSMA) Imaging for Detection of Residual and Metastatic Prostate Cancer
A Phase 2 study, sponsored by Washington University School of Medicine.
- Not yet
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT07593079: Clinical Trial Phase 2 study, sponsored by Washington University School of Medicine.
NCT07593079 is a Phase 2 study that has not yet begun recruiting, run by Washington University School of Medicine. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07593079, a Phase 2 study, has not yet begun recruiting, sponsored by Washington University School of Medicine.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
This is a randomized, open-label, pilot study assessing the impact of a short course of bicalutamide on PSMA expression in patients with prostate cancer belonging to the intermediate unfavorable or high risk group, who have low levels of PSA. Adult patients with biochemically recurrent prostate cancer (BCR PCa) who have a PSA of less than 1.0 ng/mL and who have undergone complete prostatectomy and/or will be undergoing radiotherapy, in combination with standard of care bicalutamide, will be recruited to this study. Patients will be randomized in a 1:1 ratio into Group A (baseline PSMA PET/CT only with bicalutamide standard of care) or Group B (baseline PSMA PET/CT and an additional PSMA PET/CT after 2 weeks of bicalutamide).
Primary Outcome
Differences in lesion detection rates between Group B PET1 and PET2 will be analyzed by McNemar's test. Lesion detection rates will be reported by Group B patients at PET1 and PET2 scans and by the two scan sets (first 5 minutes and at 60 minutes post 18F-rhPSMA-7.3 injection).
Interventions
- DRUG Bicalutamide
- DRUG 18F-rhPSMA-7.3
- DEVICE Prostate-specific membrane antigen Positron Emission Tomography-Computed Tomography
- DIAGNOSTIC_TEST PROSTest
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2026-07-31 |
| Est. Completion | 2027-10-31 |
| Phase | Phase 2 |
What is known before NCT07593079 opens enrollment
NCT07593079 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 4 interventions - of which Bicalutamide is the first listed.
NCT07593079 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07593079 about?
NCT07593079 is a clinical study titled "Prostate Specific Membrane Antigen (PSMA) Imaging for Detection of Residual and Metastatic Prostate Cancer". This is a randomized, open-label, pilot study assessing the impact of a short course of bicalutamide on PSMA expression in patients with prostate cancer belonging to the intermediate unfavorable or high risk group, who have low levels of PSA. Adult patients with biochemically recurrent prostate canc...
What is the current status of trial NCT07593079?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2026-07-31. Estimated completion is 2027-10-31.
What interventions are being tested in trial NCT07593079?
The interventions under investigation include: Bicalutamide (DRUG), 18F-rhPSMA-7.3 (DRUG), Prostate-specific membrane antigen Positron Emission Tomography-Computed Tomography (DEVICE), PROSTest (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT07593079?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07593079's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 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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