Clinical trial · Interventional
Using PSMA PET-CT as a Diagnostic Tool for Detection of Prostatic Cancer at an Early Stage
NCT04116086CI-TRIAL-00041000unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of the study is the evaluation of the possible role of PSMA PET-CT in early detection of prostate cancer, reducing rate of unnecessary prostate biopsies, and in cases of prostate cancer, correct staging of the disease and corresponding management.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prostate Biopsy Test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- PSMA PET-CT exam
- description
- Ga 68 -PSMA PET/CT scanning will be performed using a combined PET/CT protocol with a 16-detector-row helical CT scanner (Philips Gemini GXL). This scanner allows simultaneous acquisition of up to 45 transaxial PET images with interslice spacing of 5 mm in one bed position and provides an image from the vertex to the thigh in about 10 bed positions. The use of (68)Ga-PSMA HBED-CC results in a relatively low radiation exposure, delivering organ doses that are comparable to those of other (68)Ga-labelled PSMA-inhibitors used for PET-imaging. Total effective dose is lower than for other PET-agents used for prostate cancer imaging (e.g. (11) C- and (18) F-Choline).
- interventionNames
- Diagnostic Test: Prostate Biopsy Test
Primary outcomes (1)
- measure
- Prostate Cancer Diagnosis
- timeFrame
- 2 months
- description
- One investigator will interpret the PSMA PET-CT and another one will interpret MRI, both in a blinded and independent fashion and before the biopsy. At the end of the study, these 'blind' PSMA PET-CT and MRI reports will be compared to each other and to the actual fusion biopsy results. In the event that a high correlation is found between the diagnostic imaging results to those of the fusion biopsies, it would suggest that PSMA PET-CT could give the option to be performed instead of the need for biopsy in men who present with high levels of PSA and prompt treatment accordingly.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Men aged 40-75 2. With or without suspicious DRE, 3. Were referred by their treating physicians for prostate cancer biopsy based on either an elevated PSA result, a suspicious DRE exam, or both 4. 4 \< PSA ≤ 10 ng/ml \- Exclusion Criteria: 5. A previous diagnosis of prostate cancer 6. Underwent previous prostate biopsy 7. Previous radiation to pelvis for any reason \-
References
Publications (0)
Data not yet available
No reference posted for this study.