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NCT01808222 · ClinicalTrials.gov registry record · Phase 2
FACBC for Recurrent Prostate Cancer
A Phase 2 study, sponsored by David M. Schuster, MD.
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
NCT01808222: Completed Phase 2 study, sponsored by David M. Schuster, MD.
NCT01808222 is a Phase 2 study that has completed, run by David M. Schuster, MD. The registered enrollment target is 25 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01808222, a Phase 2 study, has completed, sponsored by David M. Schuster, MD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
Study Summary
The investigators will perform a study with 25 patients in whom the investigators have a strong suspicion of prostate cancer that has returned to the body after having an initial treatment. The major goal of the investigation is to see whether anti-\[18F\] FACBC PET-CT and MRI imaging individually will be useful in the detection of local and extraprostatic recurrence of prostate cancer. Routine blood test will be done on the day of the FACBC scan and one week later as required by the FDA. All patients will undergo biopsy of the prostate as clinically appropriate per standard of care. If either the FACBC or MRI scans indicate cancer recurrence, the subject's cancer site(s) will also be biopsied as clinically appropriate.
Primary Outcome
Participants had a fluciclovine PET-CT scan and a multiparametric magnetic imaging (mpMR) scan. The scans were read by experts (two for the PET-CT scans and two more for the mpMR scans) and the accuracy of each imaging technique was assessed by comparing the interpretations of the imaging to biopsy results. The degree of confidence of interpretation of each reader was recorded on a 5-point Likert scale where: 1. = definitely benign 2. = probably benign 3. = equivocal 4. = probably malignant 5.
Interventions
- DRUG FACBC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2013-11 |
| Est. Completion | 2017-09-13 |
| Phase | Phase 2 |
What the finished NCT01808222 record still lists
NCT01808222 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 1 intervention - of which FACBC is the first listed.
NCT01808222 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01808222 about?
NCT01808222 is a clinical study titled "FACBC for Recurrent Prostate Cancer". The investigators will perform a study with 25 patients in whom the investigators have a strong suspicion of prostate cancer that has returned to the body after having an initial treatment. The major goal of the investigation is to see whether anti-\[18F\] FACBC PET-CT and MRI imaging individually w...
What is the current status of trial NCT01808222?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2013-11. Estimated completion is 2017-09-13.
What interventions are being tested in trial NCT01808222?
The interventions under investigation include: FACBC (DRUG).
Who is sponsoring clinical trial NCT01808222?
This trial is sponsored by David M. Schuster, MD, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01808222's enrollment target sits among peer trials
25 1719th of 2000 higher than 245 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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