Phase 3
Completed N=74
68Ga-PSMA-11 PET/MRI in Finding Tumors in Patients With Intermediate or High-Risk Prostate Cancer Undergoing Surgery
Stage II Prostate Adenocarcinoma · Stage III Prostate Adenocarcinoma
Source: ClinicalTrials.gov NCT02678351 ↗
Enrolled (actual)
74
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcomePrimary: 68Ga-PSMA-11 PET Detection of Prostate Cancer Metastasized to Lymph Nodes — 19 Participants
◆ Published Evidence
Emerging
6citations · ~2 / year
Reduced Acquisition Time per Bed Position for PET/MRI Using <sup>68</sup>Ga-RM2 or <sup>68</sup>Ga-PSMA-11 in Patients With Prostate Cancer: A Retrospective Analysis.
Summary
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.
Linked Publications
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Reduced Acquisition Time per Bed Position for PET/MRI Using <sup>68</sup>Ga-RM2 or <sup>68</sup>Ga-PSMA-11 in Patients With Prostate Cancer: A Retrospective Analysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 68Ga-PSMA-11 PET Detection of Prostate Cancer Metastasized to Lymph Nodes |
19 | — |
| SECONDARY Histopathologic Detection of Prostate Cancer Metastasized to Lymph Nodes |
16 | — |
| SECONDARY Sensitivity of 68Ga-PSMA-11 PET/MRI |
56.2 | — |
| SECONDARY Specificity of 68Ga-PSMA-11 PET/MRI |
85.4 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT02678351) and the linked publication. 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.