Clinical trial · Interventional
Combined PSMA PET/MRI for Detection of Lymph Node Metastases in High-risk Prostate Cancer Patients
- 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)
For high-risk prostate cancer patients, detection of lymph node metastases is crucial to ensure optimal treatment. Standard treatment for these patients is radiotherapy or surgery. The surgery involves resection of the prostate and the pelvic lymph nodes. Currently, the most reliable method to confirm lymph node metastases is by histologic examination of the resected lymph nodes. Ideally, one should be able to detect lymph node metastases prior to treatment. Then, the treatment could be better adjusted to each patient. Imaging methods such as prostate specific membrane antigen positron emission tomography (PSMA-PET) can possibly aid the detection of lymph node metastases. In this study, the investigators want to test whether PSMA-PET or a combination of PSMA-PET and MRI (magnetic resonance imaging) can improve staging of lymph nodes before treatment.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasm Metastasis | — | UNRESOLVED | — |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PSMA-PET | Diagnostic Test | — | UNRESOLVED |
| PSMA-PET/CT | Diagnostic Test | — | UNRESOLVED |
| PSMA-PET/MRI | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PSMA-PET/MRI and PET/CT for detection of lymph node metastases.
- description
- Each patients will undergo an MRI-, PET/MRI- and PET/CT-examination (on the same day) prior to treatment. Patients in the radiotherapy cohort will additionally undergo an MRI examination after hormonal treatment, before radiotherapy.
- interventionNames
- Diagnostic Test: PSMA-PET
- Diagnostic Test: PSMA-PET/MRI
- Diagnostic Test: PSMA-PET/CT
Primary outcomes (1)
- measure
- Diagnostic accuracy of PSMA PET and combined PSMA PET/MRI
- timeFrame
- 1 month
- description
- To compare the diagnostic accuracy of PSMA PET and combined PSMA PET/MRI to that of the current standard multiparametric MRI, using histopathology as the gold standard.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion criteria (surgery cohort): * High risk localized/locally advanced prostate cancer patients who are candidates for radical prostatectomy plus bilateral extended PLND; ISUP Gleason grade group ≥ 4 Inclusion criteria (radiotherapy cohort): * High-risk localized/locally advanced prostate cancer patients scheduled for radiation treatment of the prostate and pelvic lymph nodes; ISUP Gleason grade group ≥ 4 Exclusion criteria (surgery and radiotherapy cohort): * Prior history of any other cancer 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