Phase 2
Completed N=10
68Ga-PSMA PET/CT or PET/MRI in Evaluating Patients With Recurrent Prostate Cancer
Recurrent Prostate Carcinoma
Source: ClinicalTrials.gov NCT02488070 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Average SUVmax of Ga68 PSMA Uptake Outside the Expected Normal Biodistribution — 12.4 SUVmax
Summary
This clinical trial studies gallium-68 (68Ga)-prostate specific membrane antigen (PSMA) (gallium Ga 68-labeled PSMA ligand Glu-urea-Lys[Ahx]) positron emission tomography (PET)/computed tomography (CT) or PET/magnetic resonance imaging (MRI) in identifying prostate cancer that may have returned after a period of improvement (biochemical recurrence). 68Ga-PSMA is a radiopharmaceutical that localizes to a specific prostate cancer receptor, which can then be imaged by the PET/CT or PET/MRI scanner.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average SUVmax of Ga68 PSMA Uptake Outside the Expected Normal Biodistribution |
12.4 | — |
| PRIMARY Average SUVmean of Ga68 PSMA Uptake Outside the Expected Normal Biodistribution |
7.1 | — |
| PRIMARY Average SUVmax Focal Uptake of Ga68 PSMA (F/N Ratio) |
10.4 | — |
| PRIMARY Average SUVmean Focal Uptake of Ga68 PSMA (F/N Ratio) |
9.2 | — |
| SECONDARY Feasibility of Ga-68 PSMA PET/CT or PET/MRI Scan |
10 | — |
Eligibility Criteria
Inclusion Criteria
- Provides written informed consent
- Known diagnosis of prostate cancer
- Patient has suspected recurrence based on biochemical data (prostate specific antigen [PSA] > 2 ng/mL)
- Able to remain still for duration of each imaging procedure (about one hour)
Exclusion Criteria
- Unable to provide informed consent
- Inability to lie still for the entire imaging time
- Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
- Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance
Data sourced from ClinicalTrials.gov (NCT02488070). 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. Informational only — not medical advice.