Phase 2
N=93
FACBC PET/CT for Recurrent Prostate Cancer
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00562315 ↗Enrolled (actual)
93
Serious AEs
0.0%
Results posted
Aug 2015
Primary outcome: Primary: Number of Participants With True Positive Scans Within the Prostate Bed — 55; 41 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- FACBC (Drug); ProstaScinct (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- David M. Schuster, MD
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With True Positive Scans Within the Prostate Bed |
55; 41 | — |
| PRIMARY Number of Participants With False Positive Scans Within the Prostate Bed |
18; 13 | — |
| PRIMARY Number of Participants With True Negative Scans Within the Prostate Bed |
12; 17 | — |
| PRIMARY Number of Participants With False Negative Scans Within the Prostate Bed |
6; 20 | — |
| PRIMARY Number of Participants With True Positive Scans Outside the Prostate Bed |
22; 4 | — |
| PRIMARY Number of Participants With True Negative Scans Outside the Prostate Bed |
29; 26 | — |
| PRIMARY Number of Participants With False Positive Scans Outside the Prostate Bed |
1; 4 | — |
| PRIMARY Number of Participants With False Negative Scans Outside the Prostate Bed |
18; 36 | — |
| PRIMARY Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma |
55.0; 96.7; 72.9; 95.7; 61.7 | — |
| PRIMARY Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed |
90.2; 40.0; 73.6; 75.3; 66.7 | — |
| SECONDARY Diagnostic Performance of ProstaScint Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed |
67.2; 56.7; 63.7; 75.9; 45.9 | — |
| SECONDARY Diagnostic Performance of ProstaScint Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma |
10.0; 86.7; 42.9; 50.0; 41.9 | — |
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.
Eligibility Criteria
STUDY NOW CLOSED for recruitment
Inclusion Criteria
- Patients must be 18 years of age or older.
- Patients will have been originally diagnosed with localized (Stage T1c, T2, or T3 ) prostate carcinoma and have undergone what was considered definitive therapy for localized disease.
- In the case of brachytherapy, cryotherapy, or external beam radiation, treatment will have occurred at least 2 years in the past to eliminate patients with so-called "PSA bump."
- Patient will have suspicion of recurrent prostate carcinoma as defined by: ASTRO criteria of three consecutive rises of PSA or earlier if clinically appropriate, and/or nadir + 2.0 after radiotherapy, and/or greater than 0.3 after prostatectomy.
- Ability to lie still for PET scanning
- Patients must be able to provide written informed consent.
Exclusion Criteria
- Age less than 18.
- Greater than T3 disease in past
- Prior prostatectomy or 2 years since brachytherapy, cryotherapy, or external beam radiation therapy.
- Does not meet above criteria of suspicious PSA elevation
- Inability to lie still for PET scanning
- Cannot provide written informed consent.
- Bone scan findings characteristic for metastatic prostate carcinoma
- Less than 2 months since any prior prostate biopsy (to decrease false positive uptake from inflammation).
Data sourced from ClinicalTrials.gov (NCT00562315). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.