Phase 3
Completed N=44
Clinical Value of FEC-PET Combined With Endorectal MRI for Pre-therapeutic Staging of Prostate Cancer
Source: ClinicalTrials.gov NCT00520546 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Jun 2012
Primary outcomePrimary: Number of Participants With Positive or Negative Results in PET, MRI or PET/MRI for Prostate Cancer Compared to Histological Findings — 36; 26; 35; 1 participants — p=0.0526
Summary
To investigate the sensitivity of the [18F]fluoroethylcholine (FEC) Positron-Emission-Tomography/ Magnetic Resonance Imaging (PET/MRI) method in tumour detection and location (side assignment, encapsulation, invasion of the seminal vesicle) and detection of affected lymph nodes, and to compare these with presently used detection procedures (needle biopsy, digital rectal examination, transrectal ultrasound, and pre-therapeutic assessment), with a view to finding out whether the [18F]fluoroethylcholine PET/MRI method is comparable to, or superior to, the established method. Postoperative histology served as the standard of reference.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Positive or Negative Results in PET, MRI or PET/MRI for Prostate Cancer Compared to Histological Findings |
36; 26; 35; 1; 1; 0 | 0.0526 |
| SECONDARY Lesion Based Analysis of FEC-PET, Endorectal MRI and Combined FEC-PET/eMRI in All Patients |
59; 40; 55; 26; 27; 8 | 0.09 |
| SECONDARY Lesion Based Analysis of FEC-PET, Endorectal MRI and Combined FEC-PET/eMRI in Patients With Gleason Score >6 (3+3) |
27; 22; 27; 5; 9; 1 | <0.001 sig |
| SECONDARY Lesion Based Analysis of FEC-PET, Endorectal MRI and Combined FEC-PET/eMRI in Patients With Malignant Lesions >5mm (n=98) |
48; 37; 48; 24; 26; 8 | 0.002 sig |
Eligibility Criteria
Inclusion Criteria
- Histologically diagnosed prostate cancer (needle biopsy)
- Radical prostatectomy as primary treatment
- No nutrition within 12 hours before Positron-Emission-Tomography (PET)
- No food containing choline within 24 hous before PET
- Age > 50 years
Exclusion Criteria
- Total endo-prothesis of the hip region
- Clinical or chemical detection of an acute infection
- Missing patient agreement
- Secondary cancer
- Surgical treatment within 3 month before PET
- Claustrophobia
- Medical drugs with choline
- Severe liver damage
- Cardiac infarction
- Bradycardia (pulse rate < 55/min)
- Allergic reaction against Neurotropan
- Bronchial asthma
- Cardiac pacemaker
- Small metal implants (e.g., clips, cochlea-implants, etc.)
Data sourced from ClinicalTrials.gov (NCT00520546). 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.