Clinical trial · Interventional
68Ga-PSMA PET in the Prostate Cancer
Efficacy of 68Ga PSMA PET in the Diagnosis of Lymph Node Metastasis in Patients With Prostate Cancer: a Single Center Prospective Randomized Controlled Trial
NCT04967001CI-TRIAL-00073301unknownN/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)
Efficacy of 68Ga PSMA PET / CT in the diagnosis of lymph node metastasis in patients with prostate cancer: a single center prospective randomized controlled trial. To identify and compare the diagnostic efficacy of 68Ga-PSMA PET/CT and mpMRI for lymph nodes in patients with newly diagnosed prostate cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastases | — | UNRESOLVED | — |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
| PSMA-PET | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PSMA PET | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PSMAPET-MRI
- interventionNames
- Diagnostic Test: PSMA PET
- type
- EXPERIMENTAL
- label
- MRI-PSMAPET
- interventionNames
- Diagnostic Test: PSMA PET
Primary outcomes (1)
- measure
- Diagnostic accuracy of PSMA PET and combined PSMA PET/MRI or PSMA PET/CT
- timeFrame
- 2 years
- description
- To compare the diagnostic accuracy of PSMA PET and combined PSMA PET/MRI or PET/CT to that of the current standard multiparametric MRI, using histopathology as the gold standard.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * High risk localized/locally advanced prostate cancer patients who are candidates for radical prostatectomy plus bilateral extended PLND * ISUP Gleason grade group ≥ 4 Exclusion Criteria: * Prior history of any other cancer in the last 5 years excluding basal cell carcinoma Proven metastases in bones or other distant metastases * General contra-indications for MRI (pacemaker, aneurysm clips, any form of metal in the body, severe claustrophobia) * Serious concomitant systemic disorders that in the opinion of the investigator would compromise the patient's ability to complete the study or interfere with the evaluation of the efficacy and safety of the study objectives * Metal implants in the pelvic region which will deteriorate PET/MR/CT image quality.
References
Publications (0)
Data not yet available
No reference posted for this study.