Phase 3
Completed N=299
Gallium-68 PSMA-11 PET in Intermediate to High-risk Preprostatectomy Patients
Source: ClinicalTrials.gov NCT02919111 ↗Enrolled (actual)
299
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcomePrimary: Sensitivity of PSMA PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy — .43 proportion of participants
◆ Published Evidence
Highly cited
357citations · ~71 / year
Diagnostic Accuracy of 68Ga-PSMA-11 PET for Pelvic Nodal Metastasis Detection Prior to Radical Prostatectomy and Pelvic Lymph Node Dissection: A Multicenter Prospective Phase 3 Imaging Trial.
Summary
The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68-PSMA-11) in order to evaluate it's ability to detection prostate cancer in patients with high risk disease prior to prostatectomy.
Linked Publications (2)
-
Diagnostic Accuracy of 68Ga-PSMA-11 PET for Pelvic Nodal Metastasis Detection Prior to Radical Prostatectomy and Pelvic Lymph Node Dissection: A Multicenter Prospective Phase 3 Imaging Trial.
-
Presurgical <sup>68</sup>Ga-PSMA-11 Positron Emission Tomography for Biochemical Recurrence Risk Assessment: A Follow-up Analysis of a Multicenter Prospective Phase 3 Imaging Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity of PSMA PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy |
.43 | — |
| PRIMARY Specificity of of PSMA PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy |
.94 | — |
| PRIMARY Positive Predictive Value (PPV) of of PSMA PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy |
.64 | — |
| PRIMARY Negative Predictive Value (NPV) of PSMA PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy |
.87 | — |
| SECONDARY Number of Participants With Grade 3 Treatment-related Adverse Events |
— | — |
| SECONDARY Sensitivity of PSMA PET for the Detection of Extra-pelvic Nodal Metastases |
— | — |
| SECONDARY Specificity of PSMA PET for the Detection of Extra-pelvic Nodal Metastases |
— | — |
| SECONDARY Positive Predictive Value of PSMA PET for the Detection of Extra-pelvic Nodal Metastases |
— | — |
| SECONDARY Negative Predictive Value of PSMA PET for the Detection of Extra-pelvic Nodal Metastases |
— | — |
| SECONDARY Sensitivity of PSMA PET for the Detection of Visceral Metastases |
— | — |
| SECONDARY Specificity of PSMA PET for the Detection of Visceral Metastases |
— | — |
| SECONDARY Positive Predictive Value of PSMA PET Visceral Metastases |
— | — |
| SECONDARY Negative Predictive Value of PSMA PET for the Detection of Visceral Metastases |
— | — |
| SECONDARY Sensitivity of PSMA PET for the Detection of Osseous Metastases |
— | — |
| SECONDARY Specificity of PSMA PET for the Detection of Osseous Metastases |
— | — |
| SECONDARY Positive Predictive Value of PSMA PET for the Detection of Osseous Metastases |
— | — |
| SECONDARY Negative Predictive Value of PSMA PET for the Detection of Osseous Metastases |
— | — |
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).
- Diagnostic CT or MRI as part of the PET study or performed within one month of PSMA PET.
- Karnofsky performance status of greater than 50 (or Eastern Cooperative Oncology Group (ECOG) /World Health Organization (WHO) equivalent).
- Age > 18.
- Ability to understand a written informed consent document, and the willingness to sign it.
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.
Data sourced from ClinicalTrials.gov (NCT02919111) 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.