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NCT00562315 · ClinicalTrials.gov registry record · Phase 2
FACBC PET/CT for Recurrent Prostate Cancer
A Phase 2 study of Prostate Cancer, sponsored by David M. Schuster, MD.
- Completed
- Registry status
- Phase 2
- Development phase
- 128
- Enrollment target
- 1
- Study location
NCT00562315: Completed Phase 2 study of Prostate Cancer, sponsored by David M. Schuster, MD.
NCT00562315 is a Phase 2 study of Prostate Cancer that has completed, run by David M. Schuster, MD. The registered enrollment target is 128 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00562315, a Phase 2 study of Prostate Cancer, has completed, sponsored by David M. Schuster, MD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 128 participants
- Enrollment target
- 1
- Study location
Study Summary
Hypothesis:Anti-\[18F\]FACBC PET-CT will adequately detect local and extraprostatic recurrence, and lead to better characterization of disease status in restaging patients. This is a study that will test a compound (chemical substance) that has a small amount of radioactivity attached to it. This substance has a natural tendency to go to prostate tissue. The substance is called \[18\]FACBC and it is given in the form of an injection into a vein. After the substance reaches the prostate, scans called PET or Positron Emission Tomography, are done. This is similar to having CAT scans or x-rays. Usually a compound called \[18\]FDG is used for PET scans but this substance is eliminated by the kidneys and cannot reach the prostate. This substance called \[18\]FACBC is not eliminated by the kidneys and may allow tumors in the prostate to be seen better. It is sometimes difficult to tell if a growth on the prostate is cancer with scans or x-rays that are usually done. Anti-\[18F\]FACBC PET-CT will be compared to ProstaScint (In-capromab pendetide) which is the conventional imaging for prostate cancer. Investigators will be blinded of the intervention. This study will look at how the \[18\]FACBC goes into the prostate tissue and determine its ability to detect recurrent prostate cancer.
Primary Outcome
Total number of participants with positive FACBC PET-CT and ProstaScint CT scans in diagnosis of prostate cancer in the prostate bed validated by prostate biopsy and follow up.
Conditions Studied
Interventions
- DRUG FACBC
- OTHER ProstaScinct
Study Locations (1)
Georgia
- Emory University Hospital - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2007-10 |
| Est. Completion | 2015-07 |
| Phase | Phase 2 |
What the finished NCT00562315 record still lists
NCT00562315 is an interventional study that assigns participants to a tested intervention. The registered 128 participants enrollment target is mid-sized for trials with a published cap, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which FACBC is the first listed.
NCT00562315 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT00562315 about?
NCT00562315 is a clinical study titled "FACBC PET/CT for Recurrent Prostate Cancer". Hypothesis:Anti-\[18F\]FACBC PET-CT will adequately detect local and extraprostatic recurrence, and lead to better characterization of disease status in restaging patients. This is a study that will test a compound (chemical substance) that has a small amount of radioactivity attached to it. This s...
What is the current status of trial NCT00562315?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 128 participants. The study started on 2007-10. Estimated completion is 2015-07.
What conditions does trial NCT00562315 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT00562315?
The interventions under investigation include: FACBC (DRUG), ProstaScinct (OTHER).
Who is sponsoring clinical trial NCT00562315?
This trial is sponsored by David M. Schuster, MD, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00562315 being conducted?
This trial has 1 study location across Georgia. 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 NCT00562315's enrollment target sits among peer trials
128 295th of 735 higher than 441 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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