Clinical trial · Interventional
68Ga-PSMA-11 PET/MRI in Finding Tumors in Patients With Intermediate or High-Risk Prostate Cancer Undergoing Surgery
68Ga-PSMA-11 PET/MRI for Detection of Regional Nodal and Distant Metastases in Patients With Intermediate and High-Risk Prostate Cancer
- 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)
This phase 2-3 trial studies the utility of 68-gallium (68Ga)-prostate-specific membrane antigen 11 (PSMA-11) positron emission tomography/magnetic resonance imaging (PET/MRI) to find tumors in patients with prostate cancer who are undergoing resection surgery for prostate cancer that is prognostically expected to spread quickly (intermediate-risk) or is likely to come back or spread (high-risk). Diagnostic procedures, such as PET/MRI, may help find and diagnose prostate cancer, and reveal out how far the disease has spread. Radioactive drugs, such as 68Ga-PSMA-11, may bind to tumor cells that have specific receptors, and may allow doctors to see smaller tumors than the standard of care contrast-enhanced computed tomography (CT) or MRI scan.
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 |
|---|---|---|---|
| Stage III Prostate Adenocarcinoma | Prostate Adenocarcinoma | CURATED_BROADER | 0.78 |
| Stage II Prostate Adenocarcinoma | Prostate Adenocarcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-PSMA-11 | Drug | — | UNRESOLVED |
| Magnetic resonance imaging (MRI) | Procedure | — | UNRESOLVED |
| Positron Emission Tomography (PET) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-PSMA PET/MRI
- description
- Patients receive 68Ga-PSMA-11 IV. Patients then undergo PET/MRI after 45 minutes of administration of radiopharmaceutical injection.
- interventionNames
- Drug: 68Ga-PSMA-11
- Procedure: Magnetic resonance imaging (MRI)
- Procedure: Positron Emission Tomography (PET)
Primary outcomes (1)
- measure
- 68Ga-PSMA-11 PET Detection of Prostate Cancer Metastasized to Lymph Nodes
- timeFrame
- 1 Day
- description
- 68-gallium (68Ga)-prostate-specific membrane antigen (PSMA) positron emission tomography/magnetic resonance imaging (PET/MRI) will be used to detect regional nodal and distant metastases in participants with intermediate and high-risk prostate cancer scheduled to undergo prostatectomy with lymph node dissection. The data will be analyzed by imaging interpretation. Each participant will be interpreted as either positive or negative for the presence of metastatic disease by 68Ga-PSMA PET/MRI, as assessed by imaging interpretation. The outcome will be expressed as the number of participants with metastatic disease, as identified by PET/MRI, a number without dispersion.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
INCLUSION CRITERIA * Biopsy-proven prostate adenocarcinoma * Planned prostatectomy with lymph node dissection * Intermediate- to high-risk disease (as determined by elevated prostate-specific antigen (PSA) \[PSA \> 10\], T stage \[T2b or greater\], Gleason score \[Gleason score \> 6\] or other risk factors) * Karnofsky performance status of ≥ 50 \[or Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) equivalent\] * Diagnostic CT or MRI performed within 90 days of the research PET * Able to provide written consent ExCLUSION CRITERIA * Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam * Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy, including focal ablation techniques (HiFu) * Androgen deprivation therapy or other neoadjuvant treatments prior to PET imaging and surgery * Metallic implants (contraindicated for MRI)
References
Publications (1)
- DERIVEDDuan H, Baratto L, Hatami N, Liang T, Levin CS, Khalighi MM, Iagaru A. Reduced Acquisition Time per Bed Position for PET/MRI Using 68Ga-RM2 or 68Ga-PSMA-11 in Patients With Prostate Cancer: A Retrospective Analysis. AJR Am J Roentgenol. 2022 Feb;218(2):333-340. doi: 10.2214/AJR.21.25961. Epub 2021 Aug 18. PMID 34406051